Diagnostic Platform Survey / Review

Diagnostic Platform Survey / Review

Prepared By:

A. Ingram Altis Human Resources (Calgary) Inc. 633 – 6th Ave SW, Suite 550

Calgary, AB T2P 2Y5 PWGSC Contract Number: W7702-155714

Contract Scientific Authority: Dr Mary Christopher, Biologist

The scientif ic or technical validity of this Contract Report is entirely the responsibility of the Contractor and the contents do

not necessarily have the approval or endorsement of Department of National Defence of Canada.

Contract Report

DRDC-RDDC-2015-C279

March 2015

© Her Majesty the Queen in Right of Canada, as represented by the Minister of National Defence, 2015

© Sa Majesté la Reine (en droit du Canada), telle que représentée par le ministre de la Défense nationale, 2015

Table of Contents I. Definitions/Glossary ................................................................................................. 2

II. Executive Summary .................................................................................................. 5

Introduction

Overview of Analytical Principals

Survey Methodology

Analysis

III. Results ...................................................................................................................... 10

IV. Comparative Tables - Size, Efficacy, Detection, Cost, Readiness ....................................................................................................... 15

Platform Size Parameters (Dimensions/Weight) & Efficacy

Detection

Cost and Platform Readiness

Weighted Response Scores

V. Diagnostic Platform Detail Summaries ................................................................ 24

VI. Notes ......................................................................................................................... 83

VII. Appendix .................................................................................................................. 84

VIII. Diagnostic Platform Vendor Survey ..................................................................... 84

IX. Weighted Analysis of Survey Responses .............................................................. 89

X. Vendors Invited to Participate in Survey ............................................................. 94

XI. Bibliography ............................................................................................................ 97

DIAGNOSTIC PLATFORM SURVEY / REVIEW - MARCH 2015 2

Definitions/Glossary Amplification - A process in a cell by which a particular gene is replicated so that more copies are available to produce a protein for the cell's use.

Analytical Laboratory - A reference laboratory that is able to validate assays done by lower level laboratories.

Biomarker - A characteristic that is objectively measured and evaluated as an indicator of some biological state or condition. Biomarkers, in the present context, refer to messenger RNA (mRNA), proteins derived from mRNA, or metabolites.

Calibration – Set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by material measure or a reference material, and the corresponding values realized by standards.

Clinical Samples – Specimen of blood, saliva, sputum, urine etc. required for analysis.

Closed System - Systems that use manufacturer-specific reagents only. Closed systems may be advantageous due to the use of specific reagents that are validated by the manufacturers to ensure accuracy and reproducibility of test results and maintenance of equipment integrity.

Configurable – A system has the ability to design, arrange, set up, or shape with a view to a specific application or use.

Consumables – Laboratory equipment that must be regularly replaced because it wears out or is used up in a short period of time or limited use. Consumables may include: Pipettes, culture flasks, dishes, tubes, plates, chambers, microplates, roller bottles, filters, tips or film.

Deoxyribonucleic Acid (DNA) - A molecule that can be extracted from any biological material such as living or conserved tissues, cells and virus particles.

Diagnostic Laboratory - Laboratories that are typically found in hospitals or similar medical settings. Equipment would have high sample capacity and be fully automated. Size, energy signature, additional equipment, utility requirements are of limited concern. Calibration, accuracy, and ease of maintenance are critical.

Emerging Technologies - Technologies that are in the developmental pipeline.

Extraction – Removal of DNA or RNA from the cells or viruses in which it normally resides, a purification from biological samples as an early step in diagnostic processes.

Field Use - Systems that are able to be used by soldiers, first responders or researchers outside of a typical laboratory setting, and can be used in a variety of environments and weather conditions. The systems need to be small, lightweight, easy to carry, simple to operate even when personnel are wearing personal protective equipment (PPE), stand alone in operation, have limited utility requirements, disposable or reusable with minimal cleaning required for re-use, and a small energy signature for use in covert environments.

Footprint – Space occupied by a device.

Genetic Molecular Diagnostic Platform - A platform that can detect genetic material, both RNA and DNA. In the present context, the platform must be able to detect specific RNA sequences. The platform may utilize polymerase chain reaction, but is not limited to, as the means of detection.


Host-specific Biomarker - Detection of mRNA, protein or metabolite produced by the individual that is subjected to the biological condition being evaluated. In the present context, the host-specific biomarker is a marker produced by the individual infected with a pathogen, not a protein or RNA produced by the pathogen itself;

Immunological Molecular Diagnostic Platform - A platform that utilizes antibodies in order to detect nucleic acids, proteins or metabolites.

In Vitro Diagnostics (IVD) - A method of performing a diagnostic test to detect diseases, conditions, or infections outside of a living body in an artificial environment, usually a laboratory.

Lab-on-a-chip (LOC) - A device that integrates one or several laboratory functions on a single chip of only millimeters to a few square centimeters in size. LOCs deal with the handling of extremely small fluid volumes down to less than pico liters.

Messenger RNA (mRNA) - A large family of RNA molecules that convey genetic information from DNA to the ribosome, where they specify the amino acid sequence of the protein products of gene expression.

Microfluidics - science of designing, manufacturing, and formulating devices and processes that deal with volumes of fluid on the order of nanolitres or picolitres.

Mobile Laboratory/Field Hospital Platform- A system that can be used in deployable laboratories or field hospitals. Equipment can be semi-automated and some additional equipment can be present although the total space, weight and consumable requirements for all pieces of equipment in the mobile laboratory are an important parameter. Power requirements and battery life are important as the equipment would likely be operated for longer periods of time than equipment used in the field. Energy signature should be limited to maximize mobility of the laboratory and maintain camouflagability of the laboratory.

Molecular Diagnostic Platform - A platform that can detect biological markers in the genome and proteome through technologies such as polymerase chain reaction, DNA probes, biosensors, molecular labels, immunological labels, etc.

Multiplex Assay - A type of assay that simultaneously measures multiple analytes (dozens or more) in a single run/cycle of the assay. It is distinguished from procedures that measure one analyte at a time (single assay).

OEM (Original Equipment Manufacturer) – Describes a partnership in which one company makes a part or subsystem that is used in another company's end product.

Open Innovation Model – A complimentary corporate strategy in which outside ideas and technologies from a variety of sources committed to discovery or solution of a particular challenge (students, scientists, researchers, academicians, institutions, corporations) are included in the innovation process.

Open System - A system that requires acquisition of all reagents from a variety of other suppliers by the end-user. The major benefit of an open system is the possibility of selecting a wide range of reagents at a lower cost.

Peer-reviewed Scholarly Articles - Literature that is published after review by other scholars in the same field.

Point-of-care/Near-patient - Analytical patient testing activities provided within a hospital or doctor’s office, but performed outside the physical facilities of a diagnostic laboratory.

Point-of-use - The location that the diagnostic platform can be used e.g. field, mobile laboratory, diagnostic laboratory, etc.


Polymerase chain reaction (PCR) - A laboratory technique used to make multiple copies of a segment of DNA. PCR is very precise and can be used to amplify, or copy, a specific DNA target from a mixture of DNA molecules.

Primary Literature - Document or record containing first-hand information or original data on a topic, and may be obtained from the platform manufacturer/developer.

Quantitative Results – Results in numerical form, such as a measured value or percentage.

Research and Development (R&D) Partnerships - Investigative activities that a business chooses to conduct with the intention of making a discovery that can either lead to the development of new products or procedures, or to improvement of existing products or procedures.

Ribonucleic acid (RNA) - A nucleic acid present in all living cells. Its principal role is to act as a messenger carrying instructions from DNA for controlling the synthesis of proteins, although in some viruses RNA rather than DNA carries the genetic information.

Sensitivity - A measure of the proportion of actual positives which are correctly identified as such (e.g., the percentage of sick people who are correctly identified as having the condition), and is complementary to the false negative rate. (also called the true positive rate, or the recall rate in some fields)

Signature – The sounds, lights and heat (measured in BTU – British Thermal units) produced by a device. Important to maintain camouflagability of devices in a covert mobile laboratory or field setting.

Single Nucleotide Polymorphism (SNP) - A DNA sequence variation occurring commonly within a population in which a single nucleotide in the genome (or other shared sequence) differs between members of a biological species or paired chromosomes.

Specificity – A measure the proportion of negatives which are correctly identified as such (e.g., the percentage of healthy people who are correctly identified as not having the condition), and is complementary to the false positive rate. (sometimes called the true negative rate)

SWOT Analysis - An evaluation of the strengths, weaknesses, opportunities and threats associated with each platform. Strengths are characteristics of the platform that give it an advantage over other platforms; weaknesses are characteristics that give the platform a disadvantage relative to others; opportunities are elements that could be exploited; threats are elements that could cause trouble.

Technology Readiness Level (TRL) - A measure to determine how developed the platform technology and its readiness to be used as a diagnostic system. Can range from Developmental/Design phase up to Commercialization of technology.

Vertical Partnerships - A corporate strategy in which ideas and technologies from suppliers or customers (vertical relationships) are included in the innovation process or product.


Executive Summary

Introduction

This document includes the results of a comprehensive survey of currently available and emerging molecular diagnostic platforms capable of detecting host-specific biomarkers. Defence Research and Development Canada (DRDC), Suffield Research Centre, is investigating the utility of host-derived biomarkers (e.g. specific RNA sequences, protein, metabolite) for early detection of infection with a pathogen. Should candidate diagnostic biomarkers be identified, these molecular diagnostic platforms will be required to detect the candidate biomarkers in clinical diagnostic samples. The long term goal of this initiative is the development of diagnostic systems that can be used in the field by soldiers/first responders or in a mobile laboratory/field hospital (point-of-care/near-patient testing systems). In addition to the technical detail provided for each diagnostic platform, potential partnerships have also been identified, in relation to the development and integration of diagnostic assays into selected platforms.

This report reviews and scores vendor supplied information for each platform. 215 vendors were invited to submit information regarding their platforms via a survey questionnaire. (Appendix)

Scenarios of Use

The range of detection devices and systems is continually evolving and includes improvement on gold standard detection systems, as well as development of new technologies. However, in different operational environments, one device or system may be preferred over others based on situational circumstances. In the following scenarios, the distinct environments demonstrate how different situations can require different devices or systems for biological agent detection.

Man portable and field use

Field use detection devices or systems would be used by soldiers or first responders, typically outdoors in a variety of environments (e.g. extreme cold, desert, forest, plains, urban) and be subjected to various environmental conditions (e.g., heat, cold, humidity). Devices need to be small, lightweight, and easy to carry. They should be simple to operate and should not require other machinery such as centrifuges or heat blocks. Kits or devices with limited electrical requirements are preferred.

These devices can be disposable with a single use only or they can be reusable with minimal cleaning required for reuse. Signature is important in the operation of these devices or systems, as large ventilation systems or protective gear could jeopardize covert operations. Devices that can dim screens or light sources, mute sounds and alarms and have minimal thermal output are preferred. Field use devices can have a narrow range


of detectable agents, (e.g., can be specific for one particular target) because several different devices may be deployed on a mission.

In the evaluation of detection equipment for field use, factors pertaining to mobility (size), physical system requirements (e.g., battery power, water use), and operational conditions were considered as the most important criteria. An ideal field use device would be small and easily transportable, easy to maintain, able to operate in a variety of environmental conditions, and require few manual steps to operate.

Mobile laboratory/ Field hospital

Mobile and field detection devices or systems are located in mobile laboratories or field hospitals. They would likely be semi-automated or integrated into a system that is capable of a higher throughput of samples (i.e., 20-30 samples at a time). Ideally, the diagnostic laboratory or point of care detection device or system must be able to detect biological agents from all encountered samples (blood, tissue, cultured cells, and other typical samples) with a consistently high level of specificity and sensitivity.

Some additional equipment such as centrifuges and vortexes can be used during operation, although smaller systems are preferred. Size is a concern with mobile laboratory components because space is limited and the detection device or system is likely only one component of the laboratory. A mobile laboratory would ideally be able to operate for a longer period of time than a field use item, therefore consumables and manpower are a concern.

Signature is somewhat important for the mobile laboratory, as extensive safety precautions could hinder the mobility and camouflage of the mobile laboratory. The mobile laboratory detection device or system should ideally be able to detect a wide range of agents.

In the evaluation of detection equipment for mobile laboratories, sensitivity; mobility; physical system requirements; operational conditions; and versatility of sample input were considered as the most important criteria. An ideal mobile laboratory device would require few manual steps to operate; require no or little additional equipment; and would have increased throughput, speed, and potential for automation.

Overview of Analytical Principals

Diagnostic platforms provide detection of different biomarkers using different types of chemistry. A platform often uses one type of detection chemistry (immunological, genetic) for analysis, however technology is allowing for consolidation of immunoassay and nucleic acid testing into one device.

Immunoassays are chemical tests used to detect or quantify a specific substance, the analyte, in a blood or body fluid sample, using an immunological reaction. Immunoassays may be qualitative (positive or negative) or quantitative (amount measured) and are highly sensitive and specific. Their high specificity results from the use of antibodies and purified antigens as reagents. An antibody is a protein (immunoglobulin) produced by B-lymphocytes (immune cells) in response to stimulation by an antigen. Immunoassays measure the formation of antibody-antigen complexes and detect them via an indicator reaction. High sensitivity is


achieved by using an indicator system (e.g., enzyme label) that results in amplification of the measured product. Immunoassay is the method of choice for measuring analytes normally present at very low concentrations that cannot be determined accurately by other less expensive tests. Common uses include measurement of drugs, hormones, specific proteins, tumor markers, and markers of cardiac injury.

There are different types of immunoassay methodology. Immunoprecipitation is the simplest and measures the quantity of precipitate, which forms after the reagent antibody (precipitin) has incubated with the sample and reacted with its respective antigen to form an insoluble aggregate. Particle immunoassays link several antibodies to the particle, the particle is able to bind many antigen molecules simultaneously, accelerating the speed of the visible reaction. Radioimmunoassays employ radioactive isotopes to label either the antigen or antibody. This isotope emits gamma rays, which are then usually measured following removal of unbound (free) radiolabel. Enzyme immunoassays use an enzyme to label either the antibody or antigen. The sensitivity of enzyme immunoassays approaches that for radioimmunoassays, without the danger posed by radioactive isotopes. One of the most widely used enzyme methods for detection of infectious diseases is the enzyme-linked immunosorbent assay (ELISA). Fluorescent immunoassays utilize a fluorescent label or an enzyme label which acts on the substrate to form a fluorescent product. Fluorescent measurements are inherently more sensitive than colorimetric (spectrophotometric) measurements. Chemiluminescent immunoassays utilize a chemiluminescent label and chemiluminescent molecules produce light when they are excited by chemical energy and these emissions are measured by a light detector.

Molecular diagnostics comprises a rapidly evolving range of assays for the detection and analysis of nucleic acid sequences and proteins and diagnostic platforms perform testing using a variety of biomarker detection chemistries. Genetic diagnostics comprises a huge range of technologies ranging from comparatively simple techniques such as the real-time Polymerase Chain Reaction (PCR) for the quantification of nucleic acids to more complex technologies which analyse protein-based biomarkers.

PCR is the most widely used technology in molecular diagnostics, with its potential for quantification enabling assessment of DNA copy number variation, differential RNA expression levels and pathogen load. It can even be combined with disease- or pathogen-specific antibodies in a method termed ‘proximity ligation assay’, an innovative immunoassay platform that combining the sensitivity and dynamic range of PCR with antibody-based detection of proteins and other analytes to quantify protein levels, providing a more sensitive alternative to conventional ELISAs. Original PCR protocols assessed individual markers, however the trend now is towards testing for multiple targets in a single assay, multiplexing, which allows for faster high throughput testing at reduced costs.

Microchips/Biochips are arrays (or microarrays) of immobilised biomolecules that allow rapid analysis and sequencing of DNA and detection of RNA as well as of proteins. For DNA microarrays, thousands of spots are arrayed in orderly rows and columns on a solid surface (usually glass). Each spot contains multiple identical strands of DNA, with the DNA sequence on each spot being unique and representing one gene. The precise location and sequence of each spot is recorded in a computer database. In addition to the biochips, this technology requires instruments to handle the samples, read the reported molecules and analyse the resulting wealth of data. They allow massively parallel analysis of many target molecules in many samples, allowing the identification of disease-associated mutations or mRNA/miRNA expression patterns.


Survey Methodology

Evaluation criteria was provided to the contractor by DRDC in order to conduct a critical evaluation of each detection platform/system. Assessment measures included variable related to effectiveness, logistics, operations, biomarker detection, system maturity/readiness and interest in partnership development/participation. A vendor questionnaire was developed and submitted to DRDC for review and revision prior to survey commencement. The final, approved questionnaire can be viewed in the Appendix of this report.

Vendors were identified using several search strategies and included commercialized and corporate groups as well as academic laboratories and research groups. A review of the peer-reviewed literature was performed using EMBASE, cross referenced with PubMed and Web of Science. A search of conference proceedings which included presented abstracts as well as exhibitors from National and International academic meetings, including AACC Emerging Technologies for 21st Century Clinical Diagnostics April 2014, European Congress of Clinical Microbiology and Infectious Diseases, ASM Biodefense and Emerging Diseases Research Meeting, Advanced Molecular Diagnostics for Biomarker Discovery, International Molecular Medicine Tri-Conference, International Molecular Diagnostics Europe, and Biomarker World Congress. Further searches of granting agencies, scientific partnership webpages and previous reports was also undertaken. Overall 215 vendors were identified that had valid contact information available. A list of vendors can be found in the Appendix.

The contractor sent formal email invitations to vendors to participate in diagnostic platform evaluation process. These invitations included the draft criteria, the questionnaire, an outline of the process and key deadlines for inclusion, identified as two weeks following the initial contact. Two days prior to the initial invitation deadline, follow up contact was made via email, telephone or fax. After the initial deadline had passed, a final reminder was sent, indicating an extension of the deadline for an additional 10 days in order to accommodate any interested vendors. All surveys submitted were included, even two that were received >1 week after deadline extension. Respondents are indicated in the list found in the Appendix. Some (7) vendors did not wish to participate in the survey or provide details of their diagnostic platforms, others (3) indicated that they did not feel that their platform would be suitable for the needs outlined by DRDC, e.g. too large (1) (not portable), did not provide detection for identified biomarkers (1), too early in development process (Technology Readiness Level) (1).


Analysis

The information provided in writing by the vendors within the submitted questionnaires was used as the basis for assessing the different platforms. The contractor evaluated every product that submitted a completed questionnaire and translated the details into a Microsoft® Excel spreadsheet and contained both quantitative and qualitative data. Each device or system was scored relative to the evaluation criterion outlined by DRDC. Outcomes and rankings were generated using IBM® Statistical Packages for Social Sciences (SPSS) Version 19.

The systems were scored using specific criteria (quantitative and qualitative) that were weighted, based on the desired scenarios of field use and use in a mobile or field laboratory setting. Values provided by vendors related to efficacy, results reporting and associated costs were highly variable, based on platform technology and often assay dependent. Comments were also provided by vendors related to willingness to adopt new assays and partnership opportunities. This un-weighted information was subjectively considered and is provided in comparison tables and platform summaries.

Portability (10%)

•Dimensions•Weight

Throughput (5% field, 10% mobile lab)

•Single/Multiplexed (sample, test per sample run)

•Time to Result•Level of Automation

Signature (10% field, 5% mobile lab)

•Sounds•Lights•Thermal Output

Ease of Use (10%)

•Training duration•Skills required

Operational Timing (10%)

•Time to Begin Testing

•Downtime•Steps to Perform Analysis

Operational Conditions (10% field, 5% mobile lab)

•Temperature Range•Humidity Limitations•Elevation

Maintenance / Lifespan (5% field, 10% mobile lab)

•Maintenance Frequency•Lifespan of Platform•Warranty

Consumables (10%)

•Requirements•Storage Requirements•Shelf Life

System Requirements (10%)

•Electricity•Water •Gas•Battery Capability, Duration of Charge (time/tests)

Samples (10%)

•Volume required•Types of Biological Samples

•Environmental Sample Capability

Technical Readiness Level (5%)

•Commercialized•Clinical•Pre-Clinical•Investigational•Developmental

Publications (3%)

•Cited in Peer Reviewed Literature

Regulatory (2%)

•Approved•Submitted


Results Results were analyzed in two groups: Handheld Diagnostic Platforms and Portable Diagnostic Platforms. Of

note, the Fraunhofer IZI-BB IVD Platform, Fraunhofer IZI-BB (pg. 41), LuBEA (pg. 71) and geneLEAD1

(pg. 73), Precision System Science USA, Inc. are described as “Portable Platforms” and both vendors have

indicated that they can modify the technology to be a hand-held device if desired.

Three of the platforms (MAGPIX, Luminex (pg. 67), LuBEA (pg. 71), Precision Systems Science, and

Accutas (pg. 57), Aquila Diagnostic Systems), indicated an ability to perform analysis on environmental

samples (eg. water, soil, food) in additional to biological samples. The Fraunhofer ivD Platform (pg. 41), from Fraunhofer IZI-BB also noted a capability for species identification.

All vendors reported that their platforms were “Easy To Use”, or “Somewhat Easy to Use” with minimal

(basic laboratory skills, ≤4hrs training) or no specialized training or skill set required.

All vendors reported an interest in partnerships and would be pleased to discuss opportunities in assay

development. Specific details provided can be found in each platform’s summary pages.

Detection Chemistry Immunological Rapid Multi-line Assay, MP Biomedicals Asia Pacific Pte Ltd. (pg. 25)

TrueDX, True Diagnostics (pg. 39)

AgPlus Advantage, AgPlus Diagnostics Ltd. (pg. 33)

*PTDi, Bruker Daltonik GmbH (pg. 65) *LuBEA, Precision System Science USA, Inc. (pg. 71)

*Fraunhofer IZI-BB IVD Platform, Fraunhofer IZI-BB (pg. 41)

*Mycrolab Diagnostic platform, Mycrolab Diagnostics (pg. 35)

HRDR-200, Holomic, LLC. (pg. 31) BD Accuri C6 Flow Cytometer, BD Biosciences Canada (pg. 63)

*CapSenze 100, CapSenze HB (pg. 59) BD Veritor, BD Biosciences (pg. 27) LIASON, Diasorin Inc. (pg. 77)

*Ziplex System, Axela Corp. (pg. 61) LIASON XL, Diasorin Inc. (pg. 79)

Genetic/PCR PanNAT System, Micronics, Inc. (pg. 43) *PTDi, Bruker Daltonik GmbH (pg.

65) GenePOC Inc. Diagnostic system, GenePOC Inc. (pg. 45)

iDiagnostics,TIRF Labs, Inc. (pg. 29) *LuBEA, Precision System Science USA, Inc. (pg. 71)

M2000, Abbott Molecular* (pg. 81)

MOL 1001, Focus Diagnostics, Inc. (pg. 53)

Spartan RX, Spartan Bioscience Inc. (pg. 49)

geneLEAD1, Precision System Science USA, Inc. (pg. 73)

*Fraunhofer IZI-BB IVD Platform, Fraunhofer IZI-BB (pg. 41)

*Mycrolab Diagnostic platform, Mycrolab Diagnostics (pg. 35)

Accutas, Aquila Diagnostic Systems, Inc. (pg. 57)

NESDEP IU, F Cubed, LLC (pg. 75) cobas Liat, Roche Diagnostics (pg. 47)

T-COR 8, Tetracore, Inc. (pg. 51)

Lightcycler 2.0, Roche Diagnostics (pg. 69)

FilmArray, bioMerieux Canada Inc. (pg. 55)

*CapSenze 100, CapSenze HB (pg. 59)

two3, Biomeme, Inc. (pg. 37) *Ziplex System, Axela Corp. (pg. 61) * Ziplex System, CapSenze 100, PTDi, LuBEA, Fraunhofer IZI-BB IVD Platform and Mycrolab Diagnostic platform indicated that both

immunological and genetic detection chemistry are used.


Top Five Handheld Diagnostic Platforms: 1. TrueDX, True Diagnostics (pg. 39)

2. iDiagnostics,TIRF Labs, Inc. (pg. 29)

3. Mycrolab Diagnostic Platform, Mycrolab Diagnostics. (pg. 35)

4. HRDR-200, Holomic, LLC. (pg. 31)

5. AgPlus Advantage, AgPlus Diagnostics Ltd. (pg. 33)

TrueDX (pg. 39) from True Diagnostics ranked highest due to its portability, low unit cost (~$2000/unit),

being a commercialized multiplexed system that screens 12 biomarkers simultaneously, detects proteins, metabolites and nucleic acids using immunological

biomarker detection chemistry from small samples (20-30µl) of blood, saliva, urine

or stool. The system uses 18650 lithium cells charged by a mini-USB. No other

equipment is required other than the internally calibrated cassette that remain stable

for up to 2 years at room temperature. As part of the TrueDX diagnostic system,

there are also disposable readers, also with internal calibration control, LCD display and customizable assay detection capabilities for ~$10.00/test.

The iDiagnostics (pg. 29) platform from TIRF Labs, Inc. ranked a very close second due

to its portability, the flexibility of the microarray format, ability to detect nucleic acids,

protein, metabolite, chemical agents and biochemical compounds, variability of sample

types (blood, saliva, urine, sputum, biopsy, stool or smear), battery life of 6-8 hours, all

sounds and lights can be hidden and it produces 3.4 BTU. This platform is in the Design/Developmental phase and has not yet been commercialized or obtained regulatory

approval. TIRF Labs, Inc. has an Open Innovation Model for partnership and Development.

Mycrolab Diagnostic Platform, (pg. 35) is a handheld device, weighing only 400grams that uses

multiplexed detection technology and configurable assay cartridge interface that screens 8 or

more markers simultaneously. The instrument can be charged using 110V/220V and

length of charge is assay dependent. Is was designed specifically for field use as a point of care solution for unskilled users to achieve rapid and reliable laboratory quality

results for in-vitro diagnostic assays. It detects nucleic acids, protein and metabolite

using immunological and genomic chemistry from blood, plasma, serum, saliva and urine.

Results are captured by consumable cartridge and instrument and data is write-protected and therefore

tamperproof. The corporate mission of Mycrolabs is to partner with corporations and government to deliver the benefits of field-based laboratory quality IVD using handheld devices and lab on a chip consumables.


HRDR-200 (pg. 31) smartphone based reader from Holomic, LLC is an economical, handheld quantitative

reader for lateral flow immunoassay tests. It charges using a 110v power adapter and can

perform 500 tests on a single charge. It is a multiplexed system that screens up to 12 markers simultaneously with the potential for more and provides a result

in <1 minute that can be provided as encrypted data for easy transfer. It

can operate from -45 to 45°C and features instant access to electronic

health records and real-time wide area diagnostic data collection via a

secure CLOUD service. Available in both chromatographic and

fluorescent versions, the reader also features Test Developer software for R&D and manufacturing of rapid tests.

AgPlus Advantage (pg. 33) from AgPlus Diagnostics Ltd. is a 357gram handheld device developed to

require minimal operator intervention to run assays where rapid diagnostics would be of most value. The

internal rechargeable battery (110/220V) can last up to 1 week in stand-by mode, or 3 days of

testing (50 tests/day) and the on-board memory can store up to 30,000 results. Results are

associated with used ID, patient ID and are time and date stamped for traceability and the unit includes a barcode scanner for assay identification that can be used to patient

identification as well. It detects proteins, peptides, hormones, viral antigen particles,

intercellular cancer antigens via immuno-electrochemistry. Samples of 50µl serum, plasma or saliva (urine

and whole blood in development) are diluted and transferred to disposable cartridge where results are

delivered within 10 minutes. The business model of AgPlus is to work with clients partners to develop, manufacture and supply specific diagnostic test (hardware/software/test cartridges) systems to client

specifications on an exclusive or non-exclusive basis. The unit cost is approximately $5,800 and cost of test

cartridge and disposable pipette is approximately $11 per test.


Top Five PortableDiagnostic Platforms: 1. Ziplex System, Axela Corp. (pg. 61)

2. MAGPIX Instrument, Luminex Corp. (pg. 67)

3. Fraunhofer IZI-BB IVD Platform, Fraunhofer IZI-BB (pg. 41)

4. T-COR 8, Tetracore, Inc. (pg. 51)

5. GenePOC Inc. Diagnostic system, GenePOC Inc. (pg. 45)

The Ziplex® System, (pg. 61) from Axela Corp. ranked highest due to its portability, low unit cost

($5000/unit), low testing cost ($5.00 for protein assays, $10.00 nucleic acid assays) and is available as a single or four bay cartridge system and the vendor has indicated that the cartridge instrument can be modified for

handheld applications. Ziplex is not yet commercialized but is being used in CLIA regulated

environments and in clinical trials. The system simultaneously tests up to 576 targets,

typically taking quadruplicate measurements of 100-125 biomarkers. Ziplex detects

proteins (antigens and antibodies) and nucleic acids (RNA/DNA) via

hybridization and chemiluminesence from small samples (2-15µl) of serum, plasma, whole blood, saliva, nasal aspirates, urine and tissue lysates. It has been

used brain injury markers, sepsis, pathogen screening (bacteria, virus, fungi), blood

safety (HIV), parasitology, oncology and allergy. It can run on a 110/220V power supply or on battery

power. Set up is <2 minutes, as well as < 2minutes of downtime between runs. No other equipment is

required and it can operate in 10-45°C. Axela’s business model is one of co-development of new assays, including customer specific instruments and adaptation of assays to existing or partner instrumentation.

The MAGPIX Instrument (pg. 67) from Luminex Corp. is a commercialized, FDA/Health Canada

approved, multiplexing platform capable of performing qualitative and

quantitative analysis of numerous types of biomarkers, including DNA and

RNA, (including pathogen ID, genetic subtyping, gene expression), protein

(including serological, cytokines), small molecule metabolites and antigens from a variety of sample matrices (blood, nasal and throat swabs, stool, urine,

wound, air, water soil and food). It requires small sample input (as little as 10µl)

and can perform up to 50 tests in a single reaction volume, greatly reducing

sample input, reagents and labour. The analyzer uses the xMAP (Multi-Analyte Profiling) platform that uses

encoded microbeads to capture analytes, which are then labeled and read using simple, robust digital

fluorescence microscopy. Roughly 23,000 peer reviewed publications have been published on the platform. The unit costs is higher, $35,000 USD and the costs per run are assay dependent (eg. Biothreat panel

$2400/100 samples). Using a 96 well format, first results are available in 60-90 minutes, but further results

can follow at 1/minute (up to 96). The lifespan of the system is over a decade and maintenance is required

every 6 months. Luminex is actively involved in partnerships with government and private industry in assay

development, instrument development and assay manufacturing and quality control.


The Fraunhofer IZI-BB IVD Platform, (pg. 41) from Fraunhofer IZI-BB provides near patient diagnostics

in a self-contained, low cost ($1400-$7000/unit, $3.00-$7.00/run), microfluidic cartridge system in a

small, portable format that the vendor indicates can be modified to a battery run, hand-held device. The cartridge holds an electrochemical or optical biosensor, reagents and integrated

microfluidic actuators (pumps). Together with a read-out instrument it can run a bioassay in a

fully automated way without any fluidic interfaces to the instrument. The cartridge is

produced by low-cost injection-moulding processes. Within 10 to 15 minutes, a

multitude of different parameters can simultaneously be measured and displayed.

Detects nucleic acid (DNA/RNA), SNP detection, proteins, metabolites, species identification via immunoassay, serological or DNA based chemistry conducted on small

samples from a variety of biological sample types (20µl blood, serum, saliva, 2ml urine, 2-10µl tears or swabs).

The platform has been cited in the peer-reviewed literature many times in the past few years. Testing requires

minimal steps and there is no downtime between runs. Each assay run in a new disposable cartridge and

several cartridges can run in parallel. The system has a lifespan of over a decade and require no maintenance as there are no moving parts or pumps. Fraunhofer IZI-BB’s main corporate focus is integration of existing

assays into the platform and of new assay development.

T-COR 8, (pg. 51)from Tetracore, Inc. is a portable thermocycler, <5kg, designed to be a fully automated,

portable sample-to-result platform, to meet the requirements for both field-based biothreat response as well

as clinical molecular diagnostics outside the hospital core laboratory. Its operational

temperature has been tested at -4°C to 50°C. Integrated sample preparation and nucleic acid amplification cartridge and a corresponding sample

collection and transportation device that minimizes exposure to the

potentially infected samples are also designed and tested to include with this

portable device. Includes multiplexing capability with independent well control.

The unit cost is $28,500 with a target dependent run costs of $35-65. Eight tests can be performed per run and sampling to result can take 20 to 60 minutes. The T-

COR 8 can perform testing on a variety of sample types (blood, plasma, urine, stool, oral fluids,

nasopharyngeal and buccal swabs) and has a battery life of 4.5 hours per charge. All sounds and lights can be

hidden and it produces very little thermal output. Tetracore Inc shared numerous citations from the peer-

reviewed literature related to T-COR 8 and is open to co-development of assays.


GenePOC Inc. Diagnostic (pg. 45) system from GenePOC Inc. is a standalone, fully automated Point-of-

Care molecular diagnostic system (i.e. extract nucleic acids, amplify and detect nucleic acids

based on real-time PCR, or real-time RT-PCR amplification and fluorescence detection) that screens up to 12 genetic targets per disposable cartridge, providing results in less

than one hour requiring about 1 minute hands on time. The system does not have

battery capabilities, but use of an inverter is possible. Samples for testing include

whole blood, serum/plasma, urine, throat swab, nasal swab, rectal swab or vaginal

swab of volumes of 100µl to 200µl, with no need for precise metering. The unit costs is

$15,000 to $20,000 with a lifespan of >1000 days. Results are provided via a touch screen interface or can be customizable to user needs and connectivity. Maintenance is not required as every test has

on-board process control material.

Comparative Tables - Size, Efficacy, Detection, Cost, Readiness

Platform Size Parameters (Dimensions/Weight) & Efficacy

Handheld Platform Dimensions (cm)/Weight(kg)

Detection Efficacy (Diagnostic Sensitivity [DSe], Specificity [DSp], Error margin, Detection Range/Quantitative Capacity)

Rapid Multi-line Assay, MP Biomedicals Asia Pacific Pte Ltd. (pg. 25)

0.5x 0.20x0.6cm / 0.03kg DSe >99%, DSp >99%

BD Veritor, BD Biosciences (pg. 27) 5x6.5x11cm / 0.25kg DSe/DSp are assay dependent. PPA vs. PCR (sensitivity): 82.1%-94.9% for Flu A and 74.6%-83.9% for Flu B NPA vs. PCR(specificity): 93.9%- 98.6% for Flu A and 91.9%-99.6% for Flu B Group A Strep: Sensitivity (vs. Culture): 94.4% Specificity (vs. Culture): 95.7%

iDiagnostics,TIRF Labs, Inc. (pg. 29) 4x 10x16cm / 0.3kg Nucleic acids without amplification - E(-9) - E(-18) M - nanoM - attoM Protein markers - depending on antibodies used - typically - E(-6) - E(-15) microM - femtoM Metabolite markers - depending on antibodies or aptamers used - E(-6) - E(-16) microM - sub-femtoM

HRDR-200, Holomic, LLC. (pg. 31) 7.7x7.1x14.7cm / 0.3kg Limited by lateral flow test, Error margin ±2% More sensitive than visual read-out of lateral flow test.

AgPlus Advantage, AgPlus Diagnostics Ltd. (pg. 33) 3x9x19cm / 0.357kg DSe/DSp are assay dependent. Detection range for developed assays as low as 6pg/mL with upper limit of 100 ng/mL.

Mycrolab Diagnostic platform, Mycrolab Diagnostics (pg. 35)

10x10x17.5cm / 0.4kg Error Margin <5% Detection range: assay dependent

two3, Biomeme, Inc. (pg. 37) 17x7.6x6.3cm / 0.5kg DSe/DSp are assay dependent. Performance on par with standard lab equipment. Detection range down to one genomic equivalent within a single reaction well.

TrueDX, True Diagnostics (pg. 39) 24x11x10cm / 0.7kg DSe/DSp are assay dependent, error margin ±10% Detection range 10-15 pg


Portable Platform Dimensions (cm)/Weight(kg) Detection Efficacy (Diagnostic Sensitivity [DSe], Specificity [DSp], Error margin, Detection Range/Quantitative Capacity)

Fraunhofer IZI-BB IVD Platform, Fraunhofer IZI-BB (pg. 41)

14x 14x14cm / 2.5kg Assay dependent, same range as laboratory gold-standard

PanNAT System, Micronics, Inc. (pg. 43) 20x 35x12cm / 3.2kg Assay dependent

cobas Liat, Roche Diagnostics (pg. 47) 19x11.4x24.1cm / 3.76 DSe: 100% Flu A/B, 98.3% Strep A DSp: 96.8% Flue A, 94.1% Flu B, 94.2% Strep A

GenePOC Inc. Diagnostic system, GenePOC Inc. (pg. 45)

40x33x24cm / 4kg DSe/DSp - Test/method dependent Dynamic range of 7 logs, quantitative detection possible within single disposable.

Spartan RX, Spartan Bioscience Inc. (pg. 49)

12x 17x36cm / 4.2kg DSe: 100% vs DNA sequencing, DSp: 100% vs DNA sequencing, Error Margin 0% in study of 325 samples.

T-COR 8, Tetracore, Inc. (pg. 51) 8.1x27.2x30cm / 4.5kg DSe/DSp - assay specific, Error margin <1% Detection range is assay dependent. Tetracore assays are optimized for detection range of 10-1e7 copies per reaction.

MOL 1001, Focus Diagnostics, Inc. (pg. 53) 31x21x31cm / 8kg DSe/DSp: Assay dependent, Error margin: ±5% Detection range/quantitative capacity: 1 copy/mL to 5x108 copies/mL, assay dependent

Accutas, Aquila Diagnostic Systems, Inc. (pg. 57)

35x 25x40cm / 9kg DSe: 85-99%, DSp: 85-99% Error Margin ~2% Detection range: can test down to 2 malaria parasites per microlitre of blood.


16.5x25.4x39.3cm / 9kg Panel specific (Eg. DSe 95%, DSp 99% respiratory panel) Bacteria (100-1,000 CFU/mL) Viruses (10e3-10e4 PFU/mL)

CapSenze 100, CapSenze HB (pg. 59) 25x40x30cm / 12kg DSe 10-18-10-16 M9LOD) DSp depends on capture molecule, error margin ±5%. Detection Range 10-18-10-12; dynamic range.

Ziplex System, Axela Corp. (pg. 61) 15.2x20.3x25cm (single) 30.5x30.5x45.7cm / 12kg (four bay)

DSe/DSp are assay dependent. Typical CV’s for quantitation are 5‐7%. Demonstrated sensitivity examples include low femtogram/ml range for proteins, <10 copies /ml for viruses, single femtomolar detection of RNA, 4 logs of instrument dynamic range

BD Accuri C6 Flow Cytometer, BD Biosciences Canada (pg. 63)

28x54.6x42cm / 13.6kg Unknown DSe, DSp, Error Margin 5pg to 5000pg quantitative range. Variable.

PTDi, Bruker Daltonik GmbH (pg. 65) 41x31x40cm / 15.3kg DSe: 95-98% DSp: >98% in majority of targets. Limit of detection for protein analysis in pg/mL range to low ng per mL range (using a total assay time of 20 minutes); detection range from high pg per mL to low µg per mL; dynamic (quantitative) range from approx. 1-10 ng per mL to 10-100 ng per mL.

MAGPIX Instrument, Luminex Corporation (pg. 67)

43x16.5x60cm / 18kg DSe: >90% DSp: >98% in most targets Error Margin: 95% confidence. Optics measure 3.5 decades of dynamic range, correlating to rough 3-4 orders of magnitude dynamic range in analyte of interest.


LuBEA, Precision System Science USA, Inc. (pg. 71)

40x17x49cm / 22kg DSe/DSp - Target dependent

Lightcycler 2.0, Roche Diagnostics (pg. 69) 50.5x28x38.5cm / 22kg DSe/DSp - Test/method dependent

geneLEAD1, Precision System Science USA, Inc. (pg. 73)

65x17x59cm / 25kg DSe/DSp - Target dependent

NESDEP IU, F Cubed, LLC (pg. 75) 21.6x35.5x111.7cm / 25kg DSe: 93% DSp: 91% Error Margin 1.5% Detection range: Picomolar or one (1) bacteria in a 150mL sample.

LIASON, Diasorin Inc.* (pg. 77) 90x90x152cm / 90kg DSe/DSp - Test/method dependent

LIASON XL, Diasorin Inc.* (pg. 79) 152x90x152cm / 135kg DSe/DSp - Test/method dependent

M2000, Abbott Molecular* (pg. 81) 221x81x145cm / 211kg Assay Specific, Hepatitis B viral load assay we can detect down to 10 IU/mL and up to 1,000,000,000 IU/mL with 95% confidence.

*excluded from further analysis due to >40kg

Detection

Handheld Platform Detection Sample

Rapid Multi-line Assay, MP Biomedicals Asia Pacific Pte Ltd.

Protein (both antigens and antibodies to disease causing microbes) by immunological chemistry (antigen-antibody interaction)

Blood (venous whole blood, finger-pricked whole blood, serum, plasma)

BD Veritor, BD Biosciences Protein (antigen) via digital immunoassay.

Assay dependent, currently nasal and throat swabs

iDiagnostics,TIRF Labs, Inc Detects nucleic acids, protein, metabolite, certain chemical agents, certain biochemical compounds using real-time, in-situ Total Internal Reflection Fluorescence (TIRF) and luminesce assays - microarrays that use antibody, aptamer, molecular beacon, molecular switch, and other bioassays based on natural or artificial affinity reagents.

Blood, saliva, urine, sputum, biopsy, stool, smear.

HRDR-200, Holomic, LLC. Reader for detection of any biomarker measured by lateral flow immunoassay tests, eg. Proteins, metabolites.

Dependent on manufacturer of lateral flow test.

AgPlus Advantage, AgPlus Diagnostics Ltd. Proteins, peptides, hormones, viral antigen particles, intercellular cancer antigens and limited work in DNA. Detection via Immuno- electrochemistry.

Serum, plasma, saliva, just started with urine samples, limited work on whole blood, but do not anticipate to be an issue.

Mycrolab Diagnostic platform, Mycrolab Diagnostics

Nucleic acids (DNA/RNA), protein and metabolite, dependent on assay cartridge via immunological, genomic chemistry.

Blood, plasma, serum, saliva, urine

two3, Biomeme, Inc. Isothermal detection of nucleic acid targets using fluorescent probes and intercalating dyes. Real-time Polymerase Chain Reaction.

Assay dependent

TrueDX, True Diagnostics Proteins, metabolite and RNA via immunological detection chemistry.

Whole blood, saliva, stool and urine


Portable Platform Detection Sample

Fraunhofer IZI-BB IVD Platform, Fraunhofer IZI-BB Nucleic acids (DNA/RNA), SNP detection, proteins, metabolites, species identification via immunoassay, serological or DNA based chemistry. Others can be developed as well.

Blood, plasma, serum, saliva, urine, tears, swabs

PanNAT System, Micronics, Inc. Nucleic acids (RNA/DNA) of infectious disease pathogens by Polymerase Chain Reaction.

Blood, stool, urine, swabs, aspirates

cobas Liat, Roche Diagnostics Nucleic acids (specific RNA and/or DNA sequence) via molecular real-time Polymerase Chain Reaction. Currently 1 biomarker for Strep A (single) and 2 simultaneously for Flu A and B (multiplexed)

Nasopharyngeal swab specimens for Flu A/B and throat swab for Strep A

GenePOC Inc. Diagnostic system, GenePOC Inc.

Extracts nucleic acids, amplify and detect nucleic acids based on real-time Polymerase Chain Reaction, or real-time RT-PCR amplification and fluorescence detection

Whole blood, serum/plasma, urine, throat swab, nasal swab, rectal swab, vaginal swab.

Spartan RX, Spartan Bioscience Inc. Specific genetic sequences via real-time Polymerase Chain Reaction.

Buccal swabs

T-COR 8, Tetracore, Inc Nucleic acids (DNA/RNA) via real-time Polymerase Chain Reaction.

Blood, plasma, urine, stool, oral fluids, nasopharyngeal swabs, buccal swabs

MOL 1001, Focus Diagnostics, Inc. Multi-analyte molecular biomarker detection (DNA/RNA) via real-time Polymerase Chain Reaction.

Whole blood, plasma, serum, stool, nasopharyngeal swab and user defined in open mode

Accutas, Aquila Diagnostic Systems, Inc. Nucleic acids (DNA/RNA) in the future, mRNA via Polymerase Chain Reaction

Blood, saliva, urine, water

FilmArray, bioMerieux Canada Inc. Amplifies, detects and identifies genetic sequences from biological, regardless of genetic composition (RNA/DNA) of targeted agent. Gram positive and negative bacteria, enveloped and non-enveloped viruses, and yeast all at the same time. Several panels covering the most common types of infections (Respiratory, Gastro-intestinal, Bloodstream, Meningitis/Encephalitis (in development).

Blood, nasopharyngeal swab, stool, cerebral-spinal fluid.

CapSenze 100, CapSenze HB Nucleic acid sequences, protein using, immuno-; genetic; molecularly imprinted polymer (MIP); lectin.

Blood, saliva, urine

Ziplex System, Axela Corp. Proteins (antigens and antibodies) and nucleic acids (RNA/DNA) via hybridization and chemiluminesence. Demonstrated in brain injury markers, sepsis, pathogen screening (bacteria, virus, and fungi), blood safety (HIV), parasitology, oncology and allergy.

Serum, plasma, whole blood, saliva, nasal aspirates, urine, tissue lysates

BD Accuri C6 Flow Cytometer, BD Biosciences Canada

Any biomarker labeled with fluorochrome conjugated antibody. Uses fluorescence detection and quantitation. Up to four fluorochrome conjugated antibodies are incubated with sample and analyzed on a flow cytometer to detect fluorescence intensity.

Variable, typically whole blood, serum, plasma

PTDi, Bruker Daltonik GmbH Proteins; extension to metabolite (low molecular weight substances) and RNA



detection is feasible; in general also PCR-based amplification of DNA signature sequences and hybridization based detection of amplification products is possible for pathogen identification. Uses immunological detection; additional module for (RT)-PCR-based amplification of RNA biomarkers is in development

MAGPIX Instrument, Luminex Corporation Nucleic Acids (DNA/RNA, including pathogen ID, genetic subtyping, gene expression, etc), Protein (including serological, cytokines), small molecule metabolites and antigens via xMAP platform using microbead capture and digital fluorescence microscopy.

Blood, nasal and throat swabs, stool, urine, wound, environmental air, environmental water, soil, food

LuBEA, Precision System Science USA, Inc. Allergy, oncology marker, cardiac failure, clinical testing, autoimmune, pharmacogenomics, immunodeficiency, neonatal screening, genetically modified food, food allergens, protein, GMO, genes via immunological and genetic chemistry.

Whole blood, tissue, serum, plasma, hair, food, stool, water, stained blood in paper

Lightcycler 2.0, Roche Diagnostics Nucleic acids (DNA/cDNA/RNA) via Real Time Polymerase Chain Reaction: genetic, infection, disease.


geneLEAD1, Precision System Science USA, Inc. Virus/bacteria, mRNA profiling, SNP typing, mutation detection via genetic chemistry.

Whole blood, tissue, serum, swab, urine, plasma

NESDEP IU, F Cubed, LLC Nucleic acids (DNA/RNA) and proteins via AC Dielectrophoresis in a CNT-based biochip

Any fluid, blood, wound product

Cost and Platform Readiness

Handheld Platform Cost (per unit/per test) Readiness

Rapid Multi-line Assay, MP Biomedicals Asia Pacific Pte Ltd.

$10.00/ reverse lateral flow rapid test Commercialized

BD Veritor, BD Biosciences $399.00/unit $5.50 to $15.00/test, assay dependent

Commercialized

iDiagnostics,TIRF Labs, Inc $9,800.00 (USD)Application Development Kit (smartphone, iDiagnostics cradle, cartridge blanks, software, hardware, development tools, reagent kits, and protocols) $0.10 to 1.00/test

Developmental/Design

HRDR-200, Holomic, LLC. $500.00 to $1400.00 (USD) (includes integrated reader housing, smartphone, software application, and access to Holomic Cloud Services and Holomic Test Developer.) Test cost - dependent on cost of lateral flow test.

Investigational

AgPlus Advantage, AgPlus Diagnostics Ltd. £3000.00 (~$5800 CAD)/unit Investigational


£5.50/test cartridge plus disposable pipette £0.20 (~$11.00 CAD)

Mycrolab Diagnostic platform, Mycrolab Diagnostics

Unit cost not provided $5-50 (USD)/test. Variable, dependent on market volumes

Developmental/Design

two3, Biomeme, Inc. $7,500.00 (USD)/unit (monthly lease available) $10.00 to $70.00/test, assay dependent

Investigational

TrueDX, True Diagnostics Single use disposable units at ~$10 per meter device, Portable Handheld Reader at $2,500.00 per meter, USB-Powered Reader (Windows OS) at $2,000 per meter (USD)

Commercialized/Clinical

Portable Platform Detection Sample

Fraunhofer IZI-BB IVD Platform, Fraunhofer IZI-BB $1400.00-7000.00/base unit $3.00-$7.00/test, assay/volume dependent, (negotiable)

Developmental/Pre-Clinical

PanNAT System, Micronics, Inc. $30,000.00 (USD)/unit (rental/lease options available) $40.00 to $100.00/test, depending on assay/multiplexed panel

Pre-Clinical/In-house testing

cobas Liat, Roche Diagnostics Costs not provided due to regulatory status Commercialized

GenePOC Inc. Diagnostic system, GenePOC Inc.

$15,000.00-$20,000.00/unit $15.00-20.00/test (disposables), assay dependent

Investigational/Clinical

Spartan RX, Spartan Bioscience Inc. $9,995.00/base unit $150.00/ Per FDA/Health Canada approved test

Commercialized

T-COR 8, Tetracore, Inc $28,500.00 (USD)/unit $35.00-$65.00/test, target dependent

Investigational

MOL 1001, Focus Diagnostics, Inc. $60,000.00 (USD)/unit Direct test: $50.00-80.00/test Universal test: $50.00-80.00/test (for assay)

Commercialized

Accutas, Aquila Diagnostic Systems, Inc. $5,000.00/unit Value not provided/test, variable, dependent on target

Investigational

FilmArray, bioMerieux Canada Inc. $50,000.00/unit Volume dependent, average $180.00/sample

Commercialized

CapSenze 100, CapSenze HB $51,200.00/unit $10.00 + consumables/test

Pre-Clinical/In-house testing

Ziplex System, Axela Corp. $5,000.00/unit $5.00/protein assays, $10.00/ nucleic acid assays.

Clinical Trial use

BD Accuri C6 Flow Cytometer, BD Biosciences Canada

$56,000.00/unit $2.00 to $22.00/test

Investigational

PTDi, Bruker Daltonik GmbH $67,700.00/unit 10.00-100.00 EUR ($13.50-$135.00 CAD)/test, assay dependent

Commercialized

MAGPIX Instrument, Luminex Corporation $35,000.00/unit Cost per test, assay dependent. Multiplex biothreat panel (Bot A, B, E, F, ricin and SEB) $2400/100 samples (discounts for higher volume)

Commercialized


LuBEA, Precision System Science USA, Inc. $14,000.00 (USD)/unit Value not provided/test, dependent on detected target

Pre-Clinical/In-House Testing

Lightcycler 2.0, Roche Diagnostics $95,000.00/unit ~ $3.15/ reaction, based on test.

Commercialized

geneLEAD1, Precision System Science USA, Inc. $19,000.00 (USD)/unit ~$10.00 (USD)/test

Pre-Clinical/In-House Testing

NESDEP IU, F Cubed, LLC $50,000.00 (USD)/unit ~ $25.00-50.00/test, depending on target

Commercialized


Weighted Analysis – Field Use/Handheld Devices Portability Throughput Signature Ease

of Use

Operational Timing

Operational Conditions

Maintenance/

Lifespan

Consumables System Requirements

Regulatory Samples TRL Publications

/10 /5 /10 /10 /10 /10 /5 /10 /10 /2 /10 /5 /3

Rapid Multi-line Assay, MP Biomedicals Asia Pacific Pte Ltd. (pg. 25) 10 2.25 8.3 10 7.5 2.5 4.7 8.75 8.75 1 3.2 5 0

BD Veritor, BD Biosciences (pg. 27) 10 3.1 --- 10 9.16 2.5 4.2 8.75 9.38 2 1 5 3

iDiagnostics,TIRF Labs, Inc. (pg. 29) 10 4.3 8.3 10 8.8 4.2 1.7 8.75 8.13 0 7.45 1 3

HRDR-200, Holomic, LLC. (pg. 31) 10 3.8 6.6 10 8.3 4.2 4.2 6.5 8.75 2 2.91 2.5 3

AgPlus Advantage, AgPlus Diagnostics Ltd. (pg. 33) 10 3.1 6.6 10 7.16 3.2 4.7 8.75 8.75 0 5.1 2.5 3

Mycrolab Diagnostic platform, Mycrolab Diagnostics (pg. 35) 10 3.1 6.6 10 10 2.5 4.2 8.75 8.13 0 4.72 1 0

two3, Biomeme, Inc. (pg. 37) 10 2.4 8.3 10 8.8 3.2 4.7 6.25 8.13 0 4.18 2.5 3

TrueDX, True Diagnostics (pg. 39) 8.25 3.5 8.3 10 10 4.2 4.7 8.75 8.75 2 5.1 5 0

Weighted Analysis – Mobile Lab Portability Throughput Signature Ease

of Use

Operational Timing

Operational Conditions

Maintenance/

Lifespan

Consumables System Requirements

Regulatory Samples TRL Publications

/10 /10 /5 /10 /10 /5 /10 /10 /10 /2 /10 /5 /3

Fraunhofer IZI-BB IVD Platform, Fraunhofer IZI-BB (pg. 41) 8.25 9.3 3.3 10 8.3 2.1 10 6.5 7 0 6.9 1.5 3

PanNAT System, Micronics, Inc. (pg. 43) 7 6.3 3.3 10 7.2 3.3 9.2 4 7 2 5.1 1.5 0

cobas Liat, Roche Diagnostics (pg. 47) 8.25 5.3 4.2 10 8.3 2.1 9.2 6.5 7.5 2 1.5 5 3

GenePOC Inc. Diagnostic system, GenePOC Inc. (pg. 45) 5.75 8 4.2 10 5.8 2.9 7.5 6.5 8.1 0 6.9 4 0

Spartan RX, Spartan Bioscience Inc. (pg. 49) 7 5.5 4.2 10 9.2 1.25 9.2 6.5 7 2 2.7 5 3

T-COR 8, Tetracore, Inc. (pg. 51) 7 7.3 4.2 10 7.5 1.7 5 6.5 8.1 0 7.5 2.5 3

MOL 1001, Focus Diagnostics, Inc. (pg. 53) 6.25 6.7 2.5 10 9.2 1.25 4.2 4 2.3 2 5.6 5 3

Accutas, Aquila Diagnostic Systems, Inc. (pg. 57) 3.75 5 ---- 7 6.7 3.3 2.5 6.3 7.5 0 7.3 2.5 3



5 5.7 3.3 8.5 0.8 3.75 6.7 6.5 3.75 2 4.2 5 3

CapSenze 100, CapSenze HB (pg. 59) 5 7 ---- 10 5.8 2.5 7.5 5.25 7.6 1 3.8 1.5 3

Ziplex System, Axela Corp. (pg. 61) 3.75 6.3 ---- 10 7.5 2.9 9.2 6.5 7.5 1 6.9 4 0

BD Accuri C6 Flow Cytometer, BD Biosciences Canada (pg. 63) 3.75 5.5 4.2 10 5 0.8 1.7 4 3.75 0 2 2.5 3

PTDi, Bruker Daltonik GmbH (pg. 65) 1.25 6.2 2.5 10 6.7 2.5 5.8 4 7.6 0 2.9 5 3

MAGPIX Instrument, Luminex Corporation (pg. 67) 1.25 5 4.2 7.5 5 2.5 5 4 3.75 2 7.45 5 3

LuBEA, Precision System Science USA, Inc. (pg. 71) 1.25 6.3 4.2 10 7.2 3.3 3.3 6.5 3.75 0 8.4 1.5 3

Lightcycler 2.0, Roche Diagnostics (pg. 69) 1.25 7.3 4.2 8.5 6.7 2.5 10 6.5 3.75 2 3.8 5 3

geneLEAD1, Precision System Science USA, Inc. (pg. 73) 1.25 5.5 3.3 10 7.5 2.1 3.3 5.25 3.75 0 5.6 1.5 3

NESDEP IU, F Cubed, LLC (pg. 75) 1.25 4 4.16 10 5.8 0.8 4.2 8.75 8.25 0 6.5 5 0


Diagnostic Platform Detail Summaries

Rapid Multi‐line Assay MP Biomedicals Asia Pacific Pte Ltd.

MP Biomedicals Asia Pacific Pte Ltd.2 Pioneer PlaceSingapore 627885+65 6775 0008www.mpbio.com Matthew Mak

[email protected]

DETECTION:Detects protein (both antigens and antibodies to disease causing microbes) by immunological chemistry (antigen‐antibody interaction)

OPEN SYSTEM

MULTIPLEXEDScreens 4 or 5 biomarkers simultaneously. Reverse lateral flow test, 1 sample per test. Up to 5 samples/test assayed in single run or batch.

SAMPLES:Blood (venous whole blood, finger‐pricked whole blood, serum, plasma)20‐35µl No purification of sample required.Pre‐processing not required for whole blood, processing required for plasma and serum.

SEMI‐AUTOMATED (when integrated with a rapid test reader)

Cost/test: $10.00 (USD)

DESCRIPTION:• Platform involves a patented reverse lateral flow rapid test which is capable of multi‐line testing as

demonstrated in the MULTISURE HCV Antibody Assay. The rapid test results can be read and interpreted manually by eye or automation using a hand held battery operated reader.

• No laboratory equipment is needed for the assay. Test can be used in the field, as POC test or bedside test and stored and transported at room temperature at 2‐28°C.

• The reverse lateral flow platform gives a clean background after the assay is run, resulting in clear test lines for easier reading. This platform also enables multiple test lines to be incorporated in a single window, allowing multiple testing of analytes from the same microbe or different microbes.

• The diagnostic platform has been successfully tested and commercialized on various microbes.• When integrated with a reader as a diagnostic solution or system, the test can be semi‐quantitative. This

is useful to measure the increase or reduction of antigens or antibodies over subsequent sample collections. The unique multi test lines enable the design of a rapid test which can capture and detect IgA, IgM, IgG & antigens simultaneously in a single test and also be used as a rapid confirmatory assay as an alternative to immunoblot assays, saving time and money.

Rapid Test Cassette0.5x 0.20x0.6cm

20‐30g

Test Reader Approx. 2x size of cell phone

Portable/Handheld

Smart Phone Reader using Android software features, charged with 100V/220V.

Single battery charge lasts approx. 12hr or 1000 rapid test readings.

25

Evaluation Criteria Provided by Vendor

Throughput15 to 20 min.Reverse lateral flow test, 1 sample per test. Up to 5 samples/tests assayed in single run or batch.

POC/PON sample collection/analysis Yes

Cost per run $10.00 per test

SignatureSounds able to muteScreen light able to dimThermal output similar to any smart phone

Battery/ Auxiliary PowerSmart Phone Reader using Android software features, charged with 100V/220V.Single battery charge lasts approx. 12hr or 1000 rapid test readings

EnvironmentalConsumable chase buffer provided needs to stored 2‐28°C<0°C may affect image quality of smart phone reader.Manual reading of tests, no restriction

MaintenanceNo maintenance required for smart phone based reader

Warranty1 year warranty on reader.Shelf life of rapid test is indicated on kit, 20‐24 months from time of manufacturing. Software updates provided throughout lifetime of reader.

Lifespan>5years

Operational Timing3 steps 15 minutes for assay completion, +1 minute for reading and interpretation of results.If using Reader, 1 minute required between readings

Decontamination/CleaningN/A

Other Equipment requiredNo,Consumable chase buffer provided with Rapid Test.

Training/Ease of UseEasy to use – no specific training required.

Results ReportingPositive, Negative or IndeterminatePresence of test band can be assigned intensity value by Reader, corresponding to concentration of analyte in sample tested.

Sensitivity/SpecificityDSe >99%, DSp >99%

Regulatory Approval/PatentYes, Multisure HCV antibody Assay is CE approved (CE0123) and received Singapore Health Science Authority approval.

Other approvals submitted: December 2014 / FDA, FDA approval of MP Diagnostics HTLV (Human T‐Cell Lymphotropic Virus) Blot 2.4, a Western Blot for HTLV confirmatory testing and viral type discrimination.

Assays CE approved: 1. ASSURE H. pylori Rapid Test2. ASSURE HEV IgM Rapid Test3. ASSURE TB Rapid Test4. ASSURE Dengue IgA Rapid Test5. MULTISURE HCV Antibody Assay

Patent – Yes (US Patent 6,316,205 B1, SG2010000203)

Readiness Level ‐ Commercialized

Willingness to Adopt New Assays Yes

Willingness to Partner in Assay Development Yes

Partnerships: Licensing of platform, Contract Research, Contract Manufacturing

Rapid Multi‐line Assay MP Biomedicals Asia Pacific Pte Ltd.

26

BD Veritor™ BD (Becton Dickinson)

BD2100 Derry Road West, Suite 100Mississauga, Ontario L5N 0B3905‐288‐6270www.bd.com/ds/veritorsystem Chris Mitchell

[email protected]

DETECTION:Protein (antigen) via digital immunoassay.

CLOSED SYSTEM

SINGLE/MULTIPLEXEDCan detect up to two antigens in single test.

SAMPLES:Assay dependent, currently nasal and throat swabsVolume – N/A, swab eluted into reagent Purification – N/A can be performed in open environmentPre‐processing – Immerse swab into small tube of reagent, dispense contents of tube onto reagent test strip.

SEMI AUTOMATED

Cost/unit: $399.00 (reader) (CAD)

DESCRIPTION:• Eliminates the need for visual read and subjective interpretation, enabling lab‐quality accuracy for any

user.• Easy‐to‐read digital display.• System is configured to analyze and interpret additional assays as they become available.• A dependable, familiar platform that allows antigen to interact with antibodies quickly, delivering a

definitive result within minutes.• Handheld, portable.• Low cost.

5x6.5x11cm0.25kg

Portable

Uses 2 AA batteries

27


Throughput11 minutes from sampling to result


Cost per run Assay dependent ‐ $5.50 to $15.00

SignatureSounds/light – not providedThermal output – not evaluated

Battery/ Auxiliary PowerUses 2 AA batteries, number of tests has not been evaluated.

EnvironmentalKits should be stored at 2‐30°C and used at room temperature.

MaintenanceNone

WarrantyNo, but BD will replace any defective Readers.

Lifespan3000 tests.

Operational Timing<1 minute. Immerse swab into small tube of reagent, dispense contents of tube onto reagent test strip. No downtime between runs.

Decontamination/CleaningNone

Other Equipment requiredNone

Training/Ease of UseEasy to use – CLIA waived in United States, indicating no special training required.

Results ReportingPositive/Negative digitally displayed on screen.

Sensitivity/Specificity/Detection RangeDSe/DSp are assay dependent. Flu:• PPA vs. PCR (sensitivity): 82.1%‐94.9% for Flu A and

74.6%‐83.9% for Flu B• NPA vs. PCR(specificity): 93.9%‐ 98.6% for Flu A and

91.9%‐99.6% for Flu BGroup A Strep:• Sensitivity (vs. Culture): 94.4% • Specificity (vs. Culture): 95.7%

Regulatory Approval/PatentYes, FDA, Health Canada, EMAPatent – Yes

Readiness Level – Commercialized

Willingness to Adopt New Assays ‐ Yes

Willingness to Partner in Assay Development ‐ Yes

Partnerships: Willing to provide support and discuss options for assays development partnership.

SELECT CITATIONS:• Selvarangan R. Comparison of the BD Veritor™ System Flu A+B with the Alere BinaxNOW® Influenza A+B Card for detection of

influenza A and B in respiratory specimens from pediatric patients. J Clin Microbiol. 2014• Yamaguchi I, Aoyama T, Yamamoto M, et al. Evaluation of the sensitivity of a densitometry system, in judging the result of

influenza antigen‐detection kit using immunochromatography. J Jpn Soc Clin Microbiol. 2013;23(3):213.• Jim Dunn,, Prompt detection of influenza A and B viruses using the BD VeritorTM System Flu A+B, Quidel Sofia Influenza A+B

FIA, and Alere BinaxNOW Influenza A&B compared to real time RT‐PCR. DMID 2014• Rapid communications ‐A comparison of rapid point‐of‐care tests for the detection of avian influenza A(H7N9) virus, 2013, A C

Hurt, Eurosurveillance 2013• Evaluation of Rapid Influenza Diagnostic Tests for Influenza A (H3N2)v Virus and Updated Case Count —United States, 2012,

MMWR• Evaluation of the limit of detection of the BD Veritor™ system flu A+B test and two rapid influenza detection tests for influenza

virus, Katherine A. Poehling, Diagnostic Microbiology and Infectious Disease 2013

BD Veritor™ BD (Becton Dickinson)

28

iDiagnostics TIRF Labs, Inc.

TIRF Labs Inc.106 Grendon PlaceCary, North Carolina 27519919‐963‐9545www.tirf‐labs.com www.i‐diagnostics.net Dr. Alexander Asanov

Alex.asadno@tirf‐labs.com

DETECTION:Detects nucleic acid, protein and metabolite biomarkers, certain chemical agents, certain biochemical compounds using real‐time, in‐situ Total Internal Reflection Fluorescence (TIRF) and luminesce assays ‐microarrays that use antibody, aptamer, molecular beacon, molecular switch, and other bioassays based on natural or artificial affinity reagents.

OPEN SYSTEM

MULTIPLEXEDScreens from 1 to approx. 10,000 bioanalytes. iDiagnostics microarray is flexible, can use single bioassay without internal standards or 10000 microarray spots that include internal standards, calibration, and normalization assays. Typical application, for example, detection of an infectious disease requires from 4 to 32 assays.

SAMPLES:Blood, saliva, urine, sputum, biopsy, stool, smear. 50‐100µl Minimal purification/pre‐processing required.

Cost/unit: $9,800.00 (USD) Application Development Kit (ADK), which

consists of a smartphone, iDiagnostics cradle, cartridge blanks, software,

hardware, development tools, reagent kits, and protocols

DESCRIPTION:• Open Innovation Platform for Collaborative Development of Advanced Molecular Diagnostics• iDiagnostics consists of a cradle and a disposable cartridge, using iPhone or other smartphone to acquire

and analyze the response of real‐time TIRF microarray. • Features TIRF microarrays that simultaneously, in real‐time mode detect protein, nucleic acid, and

metabolite biomarkers of different diseases. • Requires no or minimal sample preparation and is capable of detecting either a single or up to several

thousands of molecular markers in a droplet of blood or any other biological fluid.• Micro‐RNA circulating in blood can be detected with Limit of Detection (LOD) in the range of 10‐18 M. For

other assays that measure protein and metabolite concentrations, LOD depends on the assay. For certain antibody‐based assays it is at the level of ~10‐51M. The broad dynamic range of iTIRF sensor covers the entire spectrum of clinically significant concentrations of bioanalytes.

4x 10x16cm0.3kg

Portable/Handheld

Internal rechargeable battery 3.7VDC, 6‐8 hours of operation. AC/DC power adapter.

29


ThroughputSeveral seconds, to several minutes.

POC/PON sample collection/analysis Yes – using disposable cartridges

Cost per run $0.10 to 1.00

SignatureSounds able to muteScreen light able to dimThermal output similar to any smart phone <1W

Battery/ Auxiliary PowerInternal rechargeable battery 3.7VDC, 6‐8 hours of operation. AC/DC power adapter.

EnvironmentalLab tests have been conducted, detail not providedCartridge storage at room temp.

MaintenanceSemi‐annual maintenance recommended

Warranty1 year warranty on ADK.

Lifespanseveral yearsShelf‐life of cartridge, several months at room temp.

Operational Timing2‐3 steps, 2‐3 minutes

Decontamination/CleaningN/A – disposable cartridge contains analyzed liquids, proper disposal required.

Other Equipment requiredNo, app will be install on cell phone.

Training/Ease of UseEasy to use – minimal training, web video

Results ReportingPositive, Negative or quantitative reporting measured concentrations of bioanalytes.

Sensitivity/Specificity/Detection RangeNucleic acids without amplification ‐ E(‐9) ‐ E(‐18) M ‐nanoM ‐ attoMProtein markers ‐ depending on antibodies used ‐ typically ‐ E(‐6) ‐ E(‐15) microM ‐ femtoMMetabolite markers ‐ depending on antibodies or aptamers used ‐ E(‐6) ‐ E(‐16) microM ‐ sub‐femtoM

Regulatory Approval/PatentNo regulatory approval

Patent – pending

Readiness Level – Developmental/design



Partnerships: Open innovation model

iDiagnostics TIRF Labs, Inc.

SELECT CITATIONS:• Combined single channel and single molecule detection identifies subunit composition of STIM1‐activated transient receptor

potential canonical (TRPC) channels. Asanov A, Sampieri A, Moreno C, Pacheco J, Salgado A, Sherry R, Vaca L. Cell Calcium. 2015 Jan;57(1):1‐13.

• A relay mechanism between EB1 and APC facilitate STIM1 puncta assembly at endoplasmic reticulum‐plasma membrane junctions. Asanov A, Sherry R, Sampieri A, Vaca L. Cell Calcium. 2013 Sep;54(3):246‐56.

• A platform for combined DNA and protein microarrays based on total internal reflection fluorescence. Asanov A, Zepeda A, Vaca L. Sensors (Basel). 2012;12(2):1800‐15.

• A novel form of Total Internal Reflection Fluorescence Microscopy (LG‐TIRFM) reveals different and independent lipid raft domains in living cells. Asanov A, Zepeda A, Vaca L. Biochim Biophys Acta. 2010 Feb;1801(2):147‐55.

• Regenerable biosensor platform: a total internal reflection fluorescence cell with electrochemical control. Asanov AN, Wilson WW, Oldham PB. Anal Chem. 1998 Mar 15;70(6):1156‐63.

• Interfacial Aggregation of Bovine Serum Albumin Related to Crystallization Conditions Studied by Total Internal Reflection Fluorescence. Asanov AN, Delucas LJ, Oldham PB, Wilson WW. J Colloid Interface Sci. 1997 Dec 1;196(1):62‐73. 30

HRDR‐200 HOLOMIC LLC

HOLOMIC LLC10966 Le Conte AvenueLos Angeles, California 90024310‐443‐2070

www.holomic.com Ketaki [email protected]

DETECTION:Reader for detection of any biomarker measured by lateral flow immunoassay tests, eg. Proteins, metabolites.

CLOSED SYSTEM

MULTIPLEXEDScreens up to 12, potential for more

SAMPLES:Dependent on manufacturer of lateral flow test. Rapid tests are activated, then ready for reading.

SEMI AUTOMATED

Cost/unit: $500.00 to $1400.00 (USD) (includes integrated reader housing, smartphone, software application, and access to Holomic Cloud Services and Holomic Test Developer.)

DESCRIPTION:The Smartphone based Holomic Rapid Diagnostic Reader (HRDR‐200) is an economical, handheld, quantitative reader for lateral flow immunoassay tests, featuring instant access to electronic health records, and real‐time, wide‐area diagnostic data collection via a secure CLOUD service. The reader is ideal for point‐of‐care, telemedicine, and public health monitoring, as well as lab and factory needs. Key features include:• Trans‐visual sensitivity and high accuracy• Improves effectiveness of your qualitative and quantitative tests• Single, universal reader for all your tests‐ even different sizes or formats• Test and lot number identification as well as patient data• Barcode/QR test and patient data entry• Convenient handheld size for lab and field applications• Easy to use and customizable Graphical User Interface• Chromatographic and fluorescent options• Lateral flow, Flow‐through, and Dipstick test options• Wireless, Bluetooth, and USB connectivity to laptops, printers and EHRs• Used by providers in the office and in the field and by vendors in the lab and the factory

7.7x7.1x14.7cm0.3kg

Portable/handheld Reader

110V power adapter, 500 tests per charge

31


ThroughputOne test per run, Time from Reader turn on to Result <1 minute.


Cost per run Dependent on cost of lateral flow test.

SignatureSounds able to muteScreen light able to dimThermal output not provided

Battery/ Auxiliary Power110V power adapter, 500 tests per charge.

EnvironmentalOperating temperatures ‐45°C to 45°C

MaintenanceNo recommended schedule

Warranty6 month warranty

Lifespan3‐5 years

Operational Timing3 steps, Activation of lateral flow test with sample, turn on Reader and use verification cassette, <1 minute. No reboot required between tests.


Other Equipment requiredOnly Rapid tests per manufacturer specifications

Training/Ease of UseEasy to use – no training required

Results ReportingPositive/Negative and Quantitative reporting sent as encrypted data to mobile device, upload to Cloud server, transfer to PC or email.

Sensitivity/Specificity/Detection RangeLimited by lateral flow test, ±2%More sensitive than visual read‐out of lateral flow test.

Regulatory Approval/PatentCompliant with ISO13485 and is registered with the FDA as a Class 1 medical device.Patent – Yes

Readiness Level – Investigational



Partnerships: Distribution, OEM, Clinical Trials, New assay Development.

SELECT CITATIONS:• O. Mudanyali, S. Dimitrov, U. Sikora, S. Padmanabhan, I. Navruz and A. Ozcan, “Universal rapid diagnostic test (RDT) reader on

a cell‐phone for real‐time spatio‐temporal mapping of infectious diseases,” SPIE Photonics West, Advanced Biomedical and Clinical Diagnostic Systems XI, February 2013, San Francisco, CA, paper #8572‐48

• O. Mudanyali, S. Dimitrov, U. Sikora, S. Padmanabhan, I. Navruz and A. Ozcan, “Smart Rapid Diagnostics Test Reader running on a Cell‐Phone for Real‐time Mapping of Epidemics,” mHealthSys Workshop – Association for Computing Machinery (ACM) SenSys, Toronto, Canada (November 6, 2012) (Invited Contribution)

• Mudanyali, O.; Dimitrov, S.; Sikora, U.; Padmanabhan, S.; Navruz, I.; Ozcan, A. Integrated Rapid‐Diagnostic‐Test Reader Platform on a Cellphone. Lab Chip 2012, 12, 2678–2686.

• Kenneth E. Blick, Ph.D. Henry D. Fry Bradley Gehrs, M.D., “Evaluation of the POC Lateral Flow Thyrotest TSH Utilizing the Holomic Android “Smartphone” Reader Versus the Centaur XP TSH”, Oklahoma City, OK 73190, AACC POCT SYMPOSIUM, SAN DIEGO, SEPT 18‐21, 2014

HRDR‐200 HOLOMIC LLC

32

AgPlus Advantage AgPlus Diagnostics Ltd.

AgPlus Diagnostics Ltd.The Exchange, Colworth Science ParkSharnbrook, MK44 1LQ, UK+44 1234 867100www.agplusdiagnostics.com Keith Page

[email protected]

DETECTION:Proteins, peptides, hormones, viral antigen particles, intercellular cancer antigens and limited work in DNA. Detection via Immuno‐electrochemistry.

CLOSED SYSTEM

MULTIPLEXEDCurrent assays are monoplex, initial work has demonstrate duplex and capability of up to 4 or 5 simultaneous markers.

SAMPLES:Serum, plasma, saliva, just started with urine samples, limited work on whole blood, but do not anticipate to be an issue.50µl Aqueous solution required.

SEMI AUTOMATED

Cost/unit: £3000.00 (~$5800.00 CAD)

DESCRIPTION:• Handheld device has been developed as a simple to use system, that requires minimum operator

intervention to run assays and can easily be integrated into existing workflows where rapid diagnostics can add value to clinicians.

• Reader fully controls the running of the assay and its analysis. Once the sample has been added to the assay cartridge and inserted into the reader, the reader takes over the running of the assay. This includes the actuation of the fluids for the wash step and the ammonium thiocyanate for the reduction of the silver nanoparticles. No user intervention is required until the assay has been completed, where all that is required is the removal of the assay cartridge from the reader for disposal.

• The system is fully communication enabled with built in WiFi, Bluetooth and USB connectivity for results transfer. The reader has on board information storage and can store up to 30,000 test results.

• Assay results are all associated with a User ID, Patient ID and are time and date stamped for traceability. The reader has a built in barcode scanner that is used for identification of the assay for analysis and can also be used for scanning user and patient ID’s for ease of information capture.

• Developed in line with required ISO standards and complies with medical device directives.

3x9x19cm

0.357kg

Portable/Handheld110/220V power or internal rechargeable

battery supply

33


Throughput5 to 10 minutes, dependent on assay/analyte being detected. Single sample per cartridge analyzed by reader each time. Concept design for 3 cartridge reader.


Cost per run £5.50 per test cartridge plus disposable pipette £0.20 (~$11.00 CAD)

SignatureSounds able to muteScreen light able to dimThermal output not assessed

Battery/ Auxiliary Power110/220V power or internal rechargeable battery supply. Battery 7 days standby/3 days running at 50 tests per day.

EnvironmentalLimited environmental evaluation performed. CE marking only. Not “robusted” for military use, yet.Store test cartridges 4‐25°C

MaintenanceNo routine maintenance required. Self testing and calibration with each test run. Only 3 moving parts in system of high specification.

WarrantyNot provided

LifespanAnticipated >10,000 analyses.

Operational Timing5 steps, power on, log on user, enter patient ID, scan test cartridge bar code to calibrate system and identify assay protocol, insert cartridge.<1 minute downtime between tests.


Other Equipment requiredNone – includes test cartridge and disposable pipette


Results ReportingPositive/Negative and Quantitative results. System always calculates quantitative but software dictates Yes/No, semi or fully quantitative result is reported on display. Storage of up to 30,000 results on built‐in memory, USB csv download, WiFi and Bluetooth capable, GPRS capable.

Sensitivity/Specificity/Detection RangeDSe/DSp are assay dependent. Detection range for developed assays as low as 6pg/mL with upper limit of 100 ng/mL.

Regulatory Approval/PatentNo regulatory approvalPatent – Yes




Partnerships: Business model is to work with client partners to develop, manufacture and supply specific diagnostic test (hardware/software/test cartridge) systems to client’s specification. Can be on exclusive or non‐exclusive basis.

AgPlus Advantage AgPlus Diagnostics Ltd.

SELECT CITATIONS:• A Truly Handheld, Rapid, Sensitive Electrochemical Immunoassay Point‐of‐Care System. Courtney Nicholson

• Presented at the AACC Emerging Technologies for 21st Century Clinical Diagnostics April 2014

34

Mycrolab Diagnostics Mycrolab Diagnostics

Mycrolab DiagnosticsBristol, United Kingdom+44 7565 968199www.mycrolab.com Micah Atkin

[email protected]

DETECTION:Detects nucleic acid (DNA/RNA), protein and metabolite, dependent on assay cartridge via immunological, genomic chemistry.

OPEN SYSTEM

MULTIPLEXED8+ simultaneously

FULLY AUTOMATED

SAMPLES:Blood, plasma, serum, saliva, urineµl – ml, test dependentPurification requirements: Assay dependentPreprocessing requirements: None

Cost/unit: Not provided

DESCRIPTION:• Multiple detection technologies and configurable assay cartridge interface provides universal test

instrument with application specific cartridges.• Low cost cartridge manufacturing technologies.• Lower risk development for translating existing laboratory assays into diagnostic platform.• Corporate mission is to partner with corporations and government to deliver the benefits of field‐based,

laboratory quality IVD (In Vitro Diagnostic) testing using hand held devices and lab on a chip consumables.

• Hand‐held, universal POC (Point of Care) solution, designed so unskilled users can get rapid and reliable laboratory‐quality results anywhere for almost any IVD assay, with no training.

• Novel integration of handheld instrumentation and complex lab‐on‐a‐chip (LOC) consumables delivers key advantages:

• Eliminate highly skilled labour and expensive laboratory equipment• Eliminate the need for sample transport to a centralised laboratory• Provide immediate on‐site results leading to immediate action• Lower the costs of IVD testing• Any user can run almost any IVD protocol on one handheld MycroLab instrument, simply by

swapping consumables• Results are captured electronically by both consumable and instrument. Data is write‐protected

and therefore tamper‐proof

10x 10x17.5cm0.4kg

Portable/Handheld

Battery operated, charge from 110/220V

35


Throughput8+ tests per run, cartridges may be multiplexed or instruments linked in parallel.Clinical chemistry 5‐30 min, genomic 30‐60 min.


Cost per run Variable, dependent on market volumes, estimated $5.00‐50.00 USD.

SignatureSounds able to muteScreen light able to dimThermal output ‐ not provided

Battery/ Auxiliary PowerBattery operated, charge from 110/220VLength of charge assay dependent

EnvironmentalNot tested, designed for field use.

MaintenanceTest cards provided for system calibration, no maintenance required for product lifetime.

WarrantyNot yet commercially available.

Lifespan2‐5 years

Operational Timing<10 seconds, switch on, insert cartridge. No downtime between tests.

Decontamination/CleaningNone, cartridges fully self contained, disposable (single use)

Other Equipment requirednone


Results ReportingPositive/Negative display, analysis is quantitative.

Sensitivity/Specificity/Detection RangeError Margin <5%Detection range: assay dependent


Patent – Yes

Readiness Level – Developmental/design



Partnerships: Open to all enquiries.

Mycrolab Diagnostics Mycrolab Diagnostics

36

two3 Biomeme, Inc.

Biomeme, Inc.20 N. 3rd St. Suite 302Philadelphia, PA, USA 19106615‐473‐8622www.biomeme.com Emily Tseng

[email protected]

DETECTION:Isothermal detection of nucleic acid targets using fluorescent probes and intercalating dyes. Real‐time Polymerase Chain Reaction.

OPEN SYSTEM

SINGLE/MULTIPLEXEDScreens up to 6 markers simultaneously.

SAMPLES:Assay dependent20‐50µl Purification – Assay dependent Pre‐processing – Assay dependent

SEMI AUTOMATED

Cost/unit: $7,500.00 (USD)(monthly lease available)

DESCRIPTION:• Turns an iPhone into a mobile DNA lab that can detect nucleic acid targets with real‐time qPCR

(quantitative polymerase chain reaction) thermocycler.• It works with an app that allows recorded data to be sent and retrieved. Android‐compatible version in

the works.• Platform provides mobility in a user‐friendly form factor. • Company dedicated to creating an open platform, architecture is specifically designed to allow third‐

party assay developers to create new applications on our device.

17x7.6x6.3cm0.5kg

Portable/Handheld

Uses 110V AC/DC wall adapter or on‐board 38.5Wh battery

37


ThroughputAssay dependent, 20‐60 minutesThroughput is protocol dependent, three wells, two colors.


Cost per run Assay dependent ‐ $10.00 to $70.00

SignatureSounds able to muteScreen light able to dimThermal output minimal, similar to any smart phone, less than typical laptop fan.

Battery/ Auxiliary PowerUses 110V AC/DC wall adapter or on‐board 38.5Wh battery. 6‐8 tests per full charge.

EnvironmentalTested up to 43°C

MaintenanceNone

Warranty1 year limited warranty.

Lifespan5 years

Operational Timing<1 minute. If next sample is prepared, system downtime is <1 minute.

Decontamination/CleaningAssay dependent, system is peroxide fog tolerant.

Other Equipment requiredSample collection/prep equipmentAssays

Training/Ease of UseEasy to use

Results ReportingPositive/Negative and Quantitative reporting. Data encrypted locally on phone, as well as in‐transit. Results qualitative and positive/negative, amplification plots, Cqvalues and raw data.

Sensitivity/Specificity/Detection RangeDSe/DSp are assay dependent. Performance on par with standard lab equipment.Detection range down to one genomic equivalent within a single reaction well.

Regulatory Approval/PatentNo

Patent – Yes




Partnerships: Third parties are able to validate Biomemesample prep with existing assays or have their assays kitted into Biomeme’s lyophilized format for use in three‐well strips.

SELECT CITATIONS:• Novel Field‐Deployable PCR Platform: Migrating from Lab‐based PCR to Point of Care Testing. Karen Morgan & Gerry Guibert,

Monterey County Public Health Laboratory• Presented at the 2015 meeting of the California Association of Public Health Laboratory Directors.

two3 Biomeme, Inc.

38

TrueDX™ True Diagnostics

True Diagnostics2782 Loker Ave WestCarlsbad, California, 92010760‐683‐9158www.truediag.com Jerry Lee

[email protected]

DETECTION:Proteins, metabolite and RNA via immunological detection chemistry.

CLOSED SYSTEM (with out‐license opportunities)

MULTIPLEXED12 simultaneous markers.

SAMPLES:Whole blood, saliva, stool and urine20‐30µl Pre‐processing – sample dependent. No processing for protein biomarkers. Amplification reagents necessary for DNA/RNA determination.

SEMI AUTOMATED

Cost/unit: Single use disposable units at ~$10 per meter device, Portable Handheld Reader at $2,500.00 per meter, USB‐Powered Reader (Windows OS) at $2,000 per meter (USD)

DESCRIPTION:• CCD Image Sensor; 5" Color LCD, Touch‐Screen Display• Thermal Dot Printer by USB and/or Bluetooth available• Assay Control• Internal Battery• Automatic Calibration Control; Assay Detection; Setup• Quantitative results• Embedded QR code detection• Operating system, android 4.0• TrueDX technology provides a novel internal calibration method which enables intended uses the most

amount of flexibility when testing in the field.

24x11x10cm

0.7kg

Portable/HandheldInternal battery charged by mini USB

cable.

39


Throughput1‐12 tests per run. 5‐15 minutes to test results.


Cost per run Single use disposable units at ~$10.00 per meter device

SignatureNo soundsScreen light able to dimThermal output not provided

Battery/ Auxiliary PowerInternal 18650 lithium cell rechargeable battery, charge by mini USB cable. Duration of charge not provided.

EnvironmentalNo known restrictions.TrueDX cassettes are stable for 24 months at room temperature.

MaintenanceMinimal maintenance, occasional cleaning of exterior (mild soap/water and damp cloth)

Warranty1 year, parts and labour.

Lifespan5 years with stability data included.

Operational TimingNo set up time, no set up steps. Reader pre‐loaded with TrueDX software. Cassette has internal calibration method that eliminate the reboot time between test runs.

Decontamination/CleaningNone – TrueDx cassettes are one time disposable consumable devices.



Results ReportingPositive/Negative and Quantitative results. Results stored on local system and transferable by USB,

Sensitivity/Specificity/Detection RangeDSe/DSp are assay dependent, error margin ±10%Detection range 10‐15 pg

Regulatory Approval/PatentYes – submitted 12‐21‐12. PSA assay CE marked by MDC.Patent – Yes

Readiness Level – Clinical/commercialized



Partnerships: Contract development, license, co‐development and distribution opportunities.

Disposable over‐the‐counter Readers Customizable Assay Detection Internal Calibration

TrueDX™ True Diagnostics

40

Fraunhofer ivD Platform Fraunhofer IZI‐BB

Fraunhofer IZI‐BBAm Mühlenberg 1314476 Potsdam, Germany+49 331 58187‐314www.ivd‐platform.de www.izi.fraunhofer.de/abteilung‐biosystemintegration‐autometisierung.hi

Prof. Dr. Frank Bier / Dr. Harald PeterHarald.peter@izi‐bb.fraunhofer.de

DETECTION:Detects nucleic acid (DNA/RNA), SNP detection, proteins, metabolites, species identification via immunoassay, serological or DNA based chemistry. Others can be developed as well.

OPEN SYSTEM

MULTIPLEXED400 spotsImmunological Assay, 1‐10 parameters in parallel. DNA based, up to 400 (more possible)

SAMPLES:Blood, plasma, serum, saliva, urine, tears, swabs20µl blood, 2‐10µl tears, 2ml urine. Purification/Pre‐processing: Minimal, whole blood direct from fingertip, others may need dilution.

FULLY AUTOMATED

Cost/unit: base unit $1400‐7000.00 (CAD)

DESCRIPTION:• The Fraunhofer ivD‐platform is a self‐contained, active, microfluidic cartridge. The cartridge holds an

electrochemical or optical biosensor, reagents and integrated microfluidic actuators (pumps). Together with a read‐out instrument it can run a bioassay in a fully automated way without any fluidic interfaces to the instrument. The cartridge is produced by low‐cost injection‐moulding processes. Within 10 to 15 minutes, a multitude of different parameters can simultaneously be measured and displayed.

• The microfluidic cartridge consists of two main parts. The bottom part provides the integrated micropumpstogether with an electrical interface to the instrument. The injection‐moulded top part of the cartridge incorporates the reservoirs and the microfluidic channel system. The reservoirs can be filled from the top through filling holes. The cartridge contains eight reservoirs with different volumina (up to 150 µL), two sensor areas (for the electrochemical and optical read‐out) and a waste reservoir. The cartridge has the size of a credit card enabling the application as a point‐of‐care product.

• Advantages• Multimarker approach• Proprietary pumping• Self‐contained• Serial producible• Near‐Patient Diagnostics

14x 14x14cm<2‐3kg

Portable/Can be modified to handheld

220V power, battery possible

41


Throughput1 sample per cartridge, 5‐10 min to result (immunological blood assay). Several cartridges can run in parallel.

POC/PON sample collection/analysis Yes – using disposable cartridges

Cost per run Assay/volume dependent, $3.00‐$7.00 (negotiable)

SignatureNo soundsScreen light able to dim – e‐paperThermal output not provided

Battery/ Auxiliary Power220V power, battery power possible, minimal consumption

EnvironmentalFully contained microfluidic system, no restrictions. Not yet tested under extreme conditions/ temperatures.Storage of assays (4‐25°C)

MaintenanceNo pumps or moving parts, therefore no maintenance. Everything on disposable cartridges.

WarrantyNot yet determined

Lifespan>10 yearsShelf‐life of cartridge, 6‐24 months, depending on assay.

Operational Timing4 steps, switch on system, fill cartridge, insert cartridge, wait 5‐10 min for result. No down time, new assay runs in new cartridge.

Decontamination/CleaningN/A – disposable cartridge, fully closed.

Other Equipment requiredNo


Results ReportingPositive, Negative or Quantitative reporting possible, will be adjusted based on need. Data to mobile device pending.

Sensitivity/Specificity/Detection RangeAssay dependent, same range as laboratory gold‐standard.


Patent – pending

Readiness Level – Developmental/Design Pre‐Clinical



Partnerships: Main corporate focus, integration of existing assays into the platform and/or new assay development.

SELECT CITATIONS:• Multiplex isothermal solid‐phase recombinase polymerase amplification for the specific and fast DNA‐based detection of three

bacterial pathogens. Kersting S, Rausch V, Bier FF, von Nickisch‐Rosenegk M. Mikrochim Acta. 2014;181(13‐14):1715‐1723.• Integrated planar optical waveguide interferometer biosensors: a comparative review. Kozma P, Kehl F, Ehrentreich‐Förster E,

Stamm C, Bier FF. Biosens Bioelectron. 2014 Aug 15;58:287‐307. • Rapid detection of Plasmodium falciparum with isothermal recombinase polymerase amplification and lateral flow analysis.

Kersting S, Rausch V, Bier FF, von Nickisch‐Rosenegk M. Malar J. 2014 Mar 15;13:99. • Future of biosensors: a personal view. Scheller FW, Yarman A, Bachmann T, Hirsch T, Kubick S, Renneberg R, Schumacher S,

Wollenberger U, Teller C, Bier FF. Adv Biochem Eng Biotechnol. 2014;140:1‐28.• Integration in bioanalysis: technologies for point‐of‐care testing. Bier FF, Schumacher S. Adv Biochem Eng Biotechnol.

2013;133:1‐14.• A novel handheld fluorescent microarray reader for point‐of‐care diagnostic. Kozma P, Lehmann A, Wunderlich K, Michel D,

Schumacher S, Ehrentreich‐Förster E, Bier FF. Biosens Bioelectron. 2013 Sep 15;47:415‐20.

Fraunhofer IVD Platform Fraunhofer IZI‐BB

42

PanNAT® Molecular Diagnostic System Micronics, Inc.

Micronics, Inc.8463 154th Avenue N.E.Redmond, Washington 98052425‐895‐9197www.Micronics.net Donna DeLong

[email protected]

DETECTION:RNA and DNA of infectious disease pathogens by Polymerase Chain Reaction.

CLOSED SYSTEM

SINGLE and MULTIPLEXEDScreens 1‐20+, depending on assay.

SAMPLES:Blood, stool, urine, swabs, aspirates50‐250µl depending on sample type and assay No purification of sample required.Pre‐processing: dilution into sample buffer, depending on assay.

FULLY‐AUTOMATED

Cost/unit: $30,000.00 (USD) (rental/lease options available)

DESCRIPTION:• PanNAT molecular diagnostic system is a convenient, point of care instrument capable of processing

distinct cartridges, each designed to perform a single and /or multiplexed nucleic acid amplification assay.

• Automated from sample extraction/pre‐treatment to result readout, minimizes steps, hands on time, need for specialized personnel or separate extraction equipment.

• Uses direct biological specimens, no culture, broth enrichment or sample pre‐treatment required. • Each assay is fully integrated into the disposable cartridge that includes all necessary reagents.• Only a small volume of biological sample is required for assay performance.• The PanNAT System provides a sample on – result off answer in less than 1 hour, with no sample

preparation required. • The platform is uniquely configured for use in decentralized environments and offers full connectivity.• Cartridges incorporate reagents, eliminates reagent prep time and potential error.• Cartridges capture all assay waste, no clean up steps and safe disposal. • Micronics is advancing the PanNAT System with a focus on point of care infectious disease diagnosis

20x 35x12cm3.2kg

Portable

Can run from 110V or 220V, on‐board battery allows for 1 test.

43


Throughput<60minReverse lateral flow test, 1 sample per test. Up to 5 samples/tests assayed in single run or batch.


Cost per run $40.00 to $100.00 depending on assay/multiplexed panel

SignatureSounds able to muteScreen light able to dimThermal output to be determined

Battery/ Auxiliary PowerCan run from 110V or 220V, on‐board battery allows for completion of 1 test/panel.

EnvironmentalTo be determined. Target 5‐45°C, 10‐95% relative humidity. 0‐3000m altitude.Consumables/test cartridges stored at room temp.

MaintenanceNo maintenance required, periodic exterior cleaning if required.

Warranty1 year replacement warranty if purchased, swap anytime if on reagent rental plan.

LifespanApprox. 5years or 6000 tests.

Operational Timing<2 min. Steps: If instrument is off, Power on. Enter user name and password. Select test type to be run. Scan sample bar code or type in either sample or Patient I.D. Add sample to buffer tube and sample tube into test cartridge, Insert test cartridge. Select Run.

Other Equipment requiredDepending on test, swabs, disposable pipettes and sample buffer tubes.

Decontamination/CleaningN/A – closed systemCartridges capture all assay waste, no clean up steps and safe disposal.

Training/Ease of UseEasy to use – no specific training required. All tests CLIA moderate level of complexity, some CLIA waived.

Results ReportingPositive/Negative or Quantitative, depending on assay.Wi‐Fi capable. Color display. Results sent to printer, USB, local network or LIS/HISOn Board Data Storage Up to 350 results

Sensitivity/SpecificityTo be determined on assay by assay basis.

Regulatory Approval/PatentABORhCard FDA 510(k) submitted 2/18/2010 and cleared 4/30/2010.

Patent – Yes

Readiness Level – Pre‐clinical/In‐house Testing



Partnerships: Assay and/or platform development. Distribution partnerships. Micronics has a history of collaborations, including programs that have been federally funded. Two such programs are currently underway for assay development on the PanNAT platform. One is from the US Army and the other is NIH funded.

PanNAT® Molecular Diagnostic System Micronics, Inc.

44

GenePOC Diagnostic System GenePOC Inc.

GenePOC Inc.360 rue Franquet, Suite 100, porte 3Parc Technologique de Quebec418‐650‐3535www.genepoc‐diagnostics.com/Home.shtml Jean‐Francois Gravel

[email protected]

DETECTION:Extracts nucleic acids, amplify and detect nucleic acids based on real‐time PCR, or real‐time RT‐PCR amplification and fluorescence detection

CLOSED SYSTEM

MULTIPLEXEDScreens up to 12 genetic targets per disposable device.

SAMPLES:Whole blood, serum/plasma, urine, throat swab, nasal swab, rectal swab, vaginal swab.100µl to 200µl, no need for precise meteringPurity requirements: raw samplesPre‐processing requirements: None, except for whole blood and sputum.

FULLY AUTOMATED

Cost/unit: $15,000.00‐$20,000.00 (CAD)

DESCRIPTION:• A standalone system providing cost‐effective and fully automated Point‐of‐Care molecular diagnostic results to the

user in less than one hour requiring about 1 minute hands on time. The system is composed of an Instrument and a Disposable to receive and process a sample (i.e. extract nucleic acids, amplify and detect nucleic acids based on real‐time PCR, or real‐time RT‐PCR amplification and fluorescence detection).

• Cost leadership: consumable matrix specifically designed to reduce manufacturing and operating costs.• The platform’s cost structure stems from the small size and manufacturing simplicity of the consumable, the

instrument testing strategy as well as the capacity to easily scale production for mass volume with limited investment requirements.

• Flexibility: multi detection features that allow screening for up to 12 targets per assay and to run up to 8 different tests simultaneously. The use of a single generic sample preparation method has the flexibility to provide clinical tests for any kind of infectious agent.

• Accessibility and ease of use: stand‐alone closed system with integrated touch screen, completely autonomous allowing for untrained staff to easily and efficiently use the instrument.

40x33x24cm4kg

Portable

120/240V; 60/50Hz. Currently without battery, inverter capability possible

45


Throughput1‐8 disposables can be loaded simultaneously into the instrument per run. Each test can detect up to 12 genetic targets. 60 minutes total analysis time for DNA (64/8hrs), 90 minutes total analysis time for RNA (40/8hrs), sample‐to‐answer.


Cost per run Disposables $15.00‐20.00, assay dependent

SignatureSounds able to muteScreen light able to dimThermal output ‐ 700 Watts (peak power); 177 Wh for 1 run/60min.

Battery/ Auxiliary Power120/240V; 60/50Hz. Currently without battery (AC power). Could be operated using consumer electronics such as a power inverter and car battery with typically 1kW.h energy and 6kW peak power. Battery life would allow for at least 5 runs of 60 min. without charge (~4 runs of 90 min.)

EnvironmentalCurrently under validation Operating temperatures 15°C to 35°CRelative humidity to 80% (non condensing)Disposables, stored in sealed pouch at room temp. 2°C to 40°C

MaintenanceNone, every test disposable has on‐board process control material.

Warranty>1 year warranty, extension via service contract. Service plan based on exchange rather than repair.

Lifespan>1000 days

Operational Timing6 steps, Collect sample (e.g. swab; ~1 min), put and break swab into Sample Buffer Tube (~30s), Close with Cap‐shake‐open Sample Buffer Tube (~30s), transfer non‐precise volume with transfer device into PIE (~30s), close the disposable place it into the instrument (~30s), start run/wait for result (~60 min/~90 min). Minimal reboot between tests, <5 min.

Decontamination/CleaningNone required, closed tube assay, minimal waste.

Other Equipment requiredSample collection device (e.g. swabs). Specifically for HIV (i.e. whole blood sample), quick and simple pre‐processing tools

Training/Ease of UseEasy to use – CLIA‐waived status

Results ReportingPositive/Negative and Quantitative depending on application. Touch screen interface as well as connectivity. Data output customizable to user needs.

Sensitivity/Specificity/Detection RangeDSe/DSp ‐ Test/method dependentDynamic range of 7 logs, quantitative detection possible within single disposable.

Regulatory Approval/PatentNo – expected Q2‐2016 Europe; Q4‐2016 North America

Patent – Yes

Readiness Level – Investigational/Clinical


Willingness to Partner in Assay Development Yes, in partnership on its platform.

Partnerships: Developing or co‐developing molecular assays with a partner using its technological platform. GenePOC would manufacture disposables while distribution and sale of the disposables + instrument would be under the responsibility of the partner.

SELECT CITATIONS:• Canada’s GenePOC Eyes 2014 for Point‐of‐Care MDx System, Group B Strep Test. B. Butkus, PCR Insider October 2012. • The future of Personalized Medicine. Interview with Patrice Allibert, CEO of GENEPOC. N. Lunt. BIOTECanada February 2014.• Thinking big, building small: mini POC DNA device. K. Titus, CapToday August 2012 Feature Story. • Frost & Sullivan Award 2013 (Molecular Dx Companyof the year)

GenePOC Diagnostic System GenePOC Inc.

46

cobas®/ Liat® Roche Diagnostics

Roche Diagnostics201 Armand‐Frappier Blvd.Laval, Quebec, H7V 4A2800‐667‐2547www.rochecanada.com Stéphanie Pagé

[email protected]

DETECTION:Detects specific RNA and/or DNA sequence) via molecular Real Time Polymerase Chain Reaction

CLOSED SYSTEM

SINGLE/MULTIPLEXEDCurrently 1 biomarker for Strep A (single) and 2 simultaneously for Flu A and B (multiplexed)

SAMPLES:Nasopharyngeal swab specimens for Flu A/B and throat swab for Strep A.Pre‐processing requirements: Processing includes transfer pipette to load ~200µl of sample into cobas Liat tube, system will adjust sample volume.

FULLY AUTOMATED

Cost/unit: Not provided due to regulatory status

DESCRIPTION:• The cobas® Liat* System is a next‐generation real‐time PCR system designed for on‐demand STAT testing,

enabling use at satellite locations within your institution. The system includes a small benchtop analyzer safeguarded by an extensive array of instrument controls, and assay tubes tailor‐made for specific targets. The cobas® Liat System automates the entire testing process, from sample prep to amplification to real‐time detection. Definitive, objective PCR results that can be understood at a glance are generated—and verified by an internal process control—in 20 minutes or less.

• Compact benchtop analyzer. Convenient size for space‐challenged testing locations.• Results in 20 minutes or less. Single assay runs allow time‐sensitive testing and reporting.• Fully automated system with touchscreen guided operation. Minimal hands‐on time.• Sealed‐tube design eliminates any operator contact with reagents or other chemicals. Closed• system with instrument and internal process controls to reduce potential for cross‐contamination and

human error.• The cobas® Liat enables non‐specialized personnel to perform more sophisticated biological sample

testing in any setting with greater speed.• The cobas® Liat System is a compact, innovative real‐time PCR platform designed for on‐demand STAT

testing at the point of care or in the laboratory to support time‐sensitive diagnoses and treatment decisions.

19x11.4x24.1cm3.76kg

Portable/Handheld

Input: 110‐240V AC/50‐60Hz Output: 15V DC/8.6A

47


Throughput<20 minutes to result. 1 sample per run. Flu A/B 15minutes.


Cost per run Not provided due to regulatory status


Battery/ Auxiliary PowerInput: 110‐240V AC/50‐60Hz Output: 15V DC/8.6A

EnvironmentalOperating temperatures 15°C to 32°CRelative humidity 15‐80%<2000m above sea level (850‐1050hp)Reagent kits and Quality Control kits storage 2‐8°C

MaintenanceNone required

Warranty1 year warranty

Lifespan>5 years. Under investigation

Operational Timing3 steps. Collect sample and transfer to assay tube, scan tube barcode, insert tube into analyzer. Results in <20 min. No time required between runs, system reboot from shutdown <3 min.

Decontamination/CleaningScreen will prompt to use “cleaning tool” when required.



Results ReportingPositive/Negative or Indeterminate.

Sensitivity/Specificity/Detection RangeDSe: 100% Flu A/B, 98.3% Strep ADSp: 96.8% Flue A, 94.1% Flu B, 94.2% Strep A

Regulatory Approval/PatentFDA approved for Flu A/B and Strep ACE marked for Flu A/B, Strep A and Flue AB+RSVHealth Canada pendingPatent – Yes




Partnerships: Always open to partnerships for innovation. Eg: 2009 external collaboration led to development, testing and commercializing of H1N1 test in short period of time.

SELECT CITATIONS:• The first abstract on cobas® Liat will be presented at the upcoming ECCMID convention that will be held from April 25 to 28 in

Copenhagen. Unfortunately, due to the conference rules, information about this abstract cannot be disclosed at the present moment.

cobas®/ Liat® Roche Diagnostics

48

Spartan RX CYP2C19 Spartan Bioscience Inc.

Spartan Bioscience Inc.204 – 6 Gurdwara RoadOttawa, Ontario, K2E 8A4613‐228‐7756www.spartanbio.com Dr. Paul Lem

[email protected]

DETECTION:Detects specific genetic sequences via real‐time PCR.

CLOSED SYSTEM

MULTIPLEXED2 markers screened simultaneously.

SAMPLES:Buccal swabs<2µl Purification/Pre‐processing: None, devices uses raw, unpurified buccal swab sample.

FULLY AUTOMATED

Cost/unit: base unit $9,995.00 (CAD)

DESCRIPTION:• Sample to result in 60 minutes.• Health Canada has approve the platform for use in pharmacies and doctors’ offices due to its ease of use.• Platform being used at point‐of‐care around the world.• The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for

therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Assay will be run on the Spartan RX CYP2C19 Platform from the buccal sample collected with a buccal swab. The Spartan RX CYP2C19 Assay is not indicated to be used to predict drug response or non‐response.

• The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Platform will be used to run the Spartan RX CYP2C19 Assay.

• No pipetting. No DNA extraction. No complicated procedures. Just swab the patient's cheek and insert the sample into the tube.

12x 17x36cm4.2kg

Portable

12.0V power – Can be used on Car battery

49


Throughput1 sample per run, 3 tests per sample. 60 minutes from sample to result.


Cost per run Per FDA/Health Canada approved test is $150.00


Battery/ Auxiliary Power12.0V power – Can be used on Car batteryElectrical Compatibility: 100 to 240 VA, 50 to 60 HzMaximum Electrical Power: 150W to 500W

EnvironmentalRecommended operating temperature 18°C to 25°CRelative Humidity: 30% to 70% Non‐condensing

MaintenanceNone, device is internally calibrated.


Lifespan10 years/30,000 tests

Operational Timing2 steps, <2 minutes hands‐on time. No downtimebetween test runs.

Decontamination/CleaningN/A – Closed system.

Other Equipment requiredNo

Training/Ease of UseEasy to use – 1 hour of training provided

Results ReportingPositive, Negative results via paper printout.

Sensitivity/Specificity/Detection RangeDSe: 100% vs DNA sequencing, DSp: 100% vs DNA sequencing, Error Margin 0% in study of 325 samples.

Regulatory Approval/PatentFDA‐Cleared For In Vitro Diagnostic UseCE IVD Mark ApprovedHealth Canada Medical Device LicenseKorean Medical Device LicenseCYP2C19 pharmacogenetic test from Spartan also approved.

Patent – not indicated.




Partnerships: Developing new assays for the platform; porting over an existing assay into the platform; R&D partnerships.

SELECT CITATIONS:• Point‐of‐care genetic testing for personalisation of antiplatelet treatment (RAPID GENE): a prospective, randomised, proof‐of‐

concept trial. Roberts JD1, Wells GA, Le May MR, Labinaz M, Glover C, Froeschl M, Dick A, Marquis JF, O'Brien E, Goncalves S, Druce I, Stewart A, Gollob MH, So DY. Lancet. 2012 May 5;379(9827):1705‐11.

Spartan RX CYP2C19 Spartan Bioscience Inc.

50

T‐COR 8™ Tetracore Inc.

Tetracore Inc.9901 Belward Campus Drive, #300Rockville, Maryland 20850240‐268‐5400www.tetracore.com John F. Kelly

[email protected]

DETECTION:Detects nucleic acids (DNA/RNA) via Real Time Polymerase Chain Reaction.

OPEN SYSTEM

MULTIPLEXEDScreens 4 simultaneously

SAMPLES:Blood, plasma, urine, stool, oral fluids, nasopharyngeal swabs, buccal swabs.5‐500µl dependent on sample typePurity/Pre‐processing requirements: minimal. Sputum and urine simple processing, pre‐processing for chronic infection detection (lower viral load)

SEMI AUTOMATED

Cost/unit: $28,500.00 (USD)

DESCRIPTION:The T‐COR 8 portable thermocycler is designed to be a fully automated, portable sample‐to‐result platform, to meet the requirements for both field‐based biothreat response as well as clinical molecular diagnostics outside the hospital core laboratory. Integrated sample preparation and nucleic acid amplification cartridge and a corresponding sample collection and transportation device that minimizes exposure to the potentially infected samples are also designed and tested to include with this portable device. Includes multiplexing capability with independent well control. Multiplexing enables detection of more than one target per tube, as well as inclusion of an internal control in every single assay. The current device being sold is a four channel instrument with the ability to expand up to six channels. This means that three targets and an internal control can be interrogated in each well. Eight independent wells enable samples to be tested as they become available rather than requiring batch processing. Can run traditional RT‐PCR protocols, and can also be easily configured to run sample‐ or assay‐specific protocols. Each of the multiple protocols can be accessed and run simultaneously in the individual wells. The device has a user‐friendly touch screen user interface, and includes a bar code reader that can be applied to both sample and/or assay recognition. Platform has recently been used to run Isothermal Nucleic Acid Amplification protocols as well. All raw data for each test run can be stored locally via SD card. Includes a cloud‐driven software interface enabling real‐time communication between several computers and giving the ability to access the device and visualize results remotely through secure network. Remote access of results reduces communication time between field/bedside tests and authorities that may make a decision on treatment or disaster management. The reports/data can thus be downloaded via the secure network or USB thumb drive.

8.1x27.2x30cm<5kg

Portable

Battery powered/ 110/220V to charge

51


ThroughputEight tests per run. 20‐60 minutes from sampling to result.


Cost per run $35.00‐$65.00 – target dependent

SignatureSounds able to muteScreen light able to dimThermal output ‐ very little

Battery/ Auxiliary PowerBattery powered, 4.5hrs per charge, 110/220V to charge

EnvironmentalOperating temperatures ‐4°C to 50°CDevice is not waterproof

MaintenanceOnce per year, as per service contract

Warranty1 year warranty, extension may be purchased.

Lifespan10 years under recommended conditions

Operational Timing4 steps, (Approx. 10 minutes) to set up one run of 8 samples. No system downtime between tests.

Decontamination/CleaningExternal wipe down may be done as good lab practice.

Other Equipment requiredPre‐packed assays from Tetracore, or home brew assays may be optimized.

Training/Ease of UseEasy to use – basic training to use molecular assays.

Results ReportingPositive/Negative displayed as target specific in table format on 10” touch screen.

Sensitivity/Specificity/Detection RangeDSe/DSp ‐ assay specific, Error margin <1%Detection range is assay dependent. Tetracore assays are optimized for detection range of 10‐1e7 copies per reaction.

Regulatory Approval/PatentCE marked for lab use. Other Tetracore platform (RedLineAlert Kit, FDA approved 2003)Patent – No




Partnerships: Co‐development with partners for assay development

SELECT CITATIONS:• Almassian DR, Cockrell LM, Nelson WM, Portable nucleic acid thermocyclers, Chem Soc Rev, 2013,42, 8769‐8798• Rapid and Portable Detection of Select Agents Using Novel Real‐Time Isothermal Amplification‐Based Assays; Cockrell LM,

LaPosa C, Addison A, Diepold S, Venkateswaran N, Nelson W;Hodge D and Pillai S; Presented at ASM Biodefense, Washington DC, Feb 9th‐11th 2015

• Rapid Detection of Botulinum Toxin A by Novel Field‐Portable Real Time Polymerase Chain Reaction (RT‐PCR) Device; Venkateswaran, N, Diepold, S, Walker, J, Singh, A, Dutta, S, Sharma, S, Venkateswaran, K, O’Brien, TW, Long, G, Nelson, WmM; Presented at IBRCCOct 20‐23, 2013, Anapolis MD.

• Rapid, Portable, and Versatile Detection of Select Agents and Infectious Diseases in Environmental and Clinical Samples; L.M.Cockrell, S. Diepold, N. Venkateswaran, T. Fecteau, S. Pillay, G. Long, Wm. M. Nelson Presented at ASM Biodefense, Washington DC, Feb 2014

• A novel diagnostic platform using molecular methods to detect pathogens directly from blood samples. Nelson WM, Almassian D, Fecteau T, Rauh R, Armantrout K. Tetracore, Inc., Rockville. MD.Oakridge Conference, Emerging Clinical & Laboratory Diagnostics: The Portable Lab, Apr 24th‐25th,2014

• Rapid Direct Detection of Dengue Virus in Blood Samples by Real Time‐Polymerase Chain Reaction (RT‐PCR) using a Portable Point‐of‐Care Device William M Nelson, Tracy Fecteau, Lisa Cockrell, Neeraja Venkateswaran, Kyle Armantrout, Tetracore, Inc. Rockville, MD.30th Annual Clinical Virology Symposium, Daytona Beach, Florida, April 27th‐30th 2014

T‐COR 8™ Tetracore Inc.

52

MOL 1001 (3M™ Integrated Cycler) Focus Diagnostics, Inc.

Focus Diagnostics, Inc.11331 Valley View StreetCypress, California 90630562‐240‐6497www.focusdx.com Kay L. Myrdal

[email protected]

DETECTION:Multi‐analyte molecular biomarker detection (DNA/RNA) via real‐time PCR.

OPEN SYSTEM


SAMPLES:Whole blood, plasma, serum, stool, nasopharyngeal swab and user defined in open mode.50µl for Direct products, 2‐3µl for Universal Direct products, 200µl for extracted high complexity products.Purification – Assay dependent , extraction required for high complexity Universal products.Pre‐processing – Assay dependent

SEMI AUTOMATED


DESCRIPTION:Moderate complexity assays without extraction are available. Scalable and flexible Integrated Cycler system for qualitative and quantitative assays, with very small footprint. Multiple assays can be performed at one time in about an hour. Easily integrated into a lab’s daily operations. Supported by proven Simplexa™ chemistries.THE UNIVERSAL DISC (96 wells)

• Simplexa™ Universal Direct & Simplexa™.• For Universal Direct ‐ no extraction required.• For Simplexa™ ‐ pre‐extraction of samples needed.• Process multiple targets simultaneously.• Higher volume testing.• Results in about an hour.

THE DIRECT AMPLIFICATION DISC (8 wells)• Simplexa™ Direct ‐ no extraction required.• Direct Amplification Discs are provided with kits.• Convenience of running one sample at a time.• Easy to understand results.• Elimination of unidirectional work flow.• All‐in‐one reaction mix packaged in single use vials.• Results in about an hour.

31x21x31cm8kg

110/220V compatible or auxiliary power dependent on uninterrupted power supply (UPS)

53


ThroughputDirect amplification disc: 8 samples (1hour, 15 minutes). Universal disc: 96 samples. (with extraction 1 hour, 30 min; with extraction 3 hours, 30 min)


Cost per run Direct test: $50.00‐80.00/testUniversal test: $50.00‐80.00/test (for assay)

SignatureSounds: not providedScreen light able to dimThermal output: ~450BTU/hr

Battery/ Auxiliary Power110/220V compatible or auxiliary power dependent on uninterrupted power supply (UPS)

EnvironmentalOperating temperature: 15°C to 35°CStorage temperature: ‐10°C to 50°C20‐80% relative humidity, non‐condensingInstallation/over voltage: Category IIPollution degree: 2

MaintenanceWeekly surface clean, monthly data archive, yearly calibration, as needed decontamination.

Warranty1 year warranty, 1‐3 extension via service contract

Lifespan>5 years

Operational Timing1 step, power on. 2‐3 minutes No reboot required between tests.

Decontamination/CleaningAs needed, 5‐15 minutes.

Other Equipment requiredIntegrated Cycler Studio Software, Laptop, barcode scanner, pipette, freezer, refrigerator, biosafety cabinet, gloves, pipette tips, waterAssay Dependent: extraction system, strip plate, microcentrifuge, vortex mixer

Training/Ease of UseEasy to use – general laboratory techniques/practices, Assay dependent: CLS certified

Results ReportingPositive/Negative and Quantitative as .pdf, .lis, or .xls file, encrypted to laptop.

Sensitivity/Specificity/Detection RangeDSe/DSp: Assay dependent, Error margin: ±5%Detection range/quantitative capacity: 1 copy/mL to 5x108

copies/mL, assay dependent

Regulatory Approval/PatentRegulatory approval of device and assays: H1N1 (2009), Flu A/Flu B/RSV, CMV, EBV, BK Virus, Dengue Virus, C. difficile, Bordetella pertussis/parapertussis, Group A Strep, HSV‐1 and HSV‐2Patent – Yes




Partnerships: Open to all partnership arrangements. Current and previously partnered with various US Government agencies as well as commercial entities.

SELECT CITATIONS:• Performance of Simplexa dengue molecular assay compared to conventional and SYBR green RT‐PCR for detection of dengue

infection in Indonesia. Sasmono RT, Aryati A, Wardhani P, Yohan B, Trimarsanto H, Fahri S, Setianingsih TY, Meutiawati F. PLoS One. 2014 Aug 7;9(8):e103815

• Comparison of the Verigene Clostridium difficile, Simplexa C. difficile Universal Direct, BD MAX Cdiff, and Xpert C. difficile assays for the detection of toxigenic C. difficile. Gilbreath JJ, Verma P, Abbott AN, Butler‐Wu SM. Diagn Microbiol Infect Dis. 2014 Sep;80(1):13‐8.

• Comparison of Illumigene, Simplexa, and AmpliVue Clostridium difficile molecular assays for diagnosis of C. difficile infection. Deak E, Miller SA, Humphries RM. J Clin Microbiol. 2014 Mar;52(3):960‐3.

• Clinical comparison of Simplexa universal direct and BD GeneOhm tests for detection of toxigenic Clostridium difficile in stool samples. Nolte FS, Ribeiro‐Nesbitt DG. J Clin Microbiol. 2014 Jan;52(1):281‐2.

• Comparison of the Simplexa FluA/B & RSV direct assay and laboratory‐developed real‐time PCR assays for detection of respiratory virus. Woodberry MW, Shankar R, Cent A, Jerome KR, Kuypers J. J Clin Microbiol. 2013 Nov;51(11):3883‐5.

• Comparison of six real‐time PCR assays for qualitative detection of cytomegalovirus in clinical specimens. Binnicker MJ, Espy ME. J Clin Microbiol. 2013 Nov;51(11):3749‐52.

MOL 1001 (3M™ Integrated Cycler) Focus Diagnostics, Inc.

54

FilmArray® bioMerieux Canada Inc.

bioMerieux Canada Inc.7815 boul. Henri‐Bourassa O.St‐Laurent, Quebec H45 1P71‐800‐361‐7321www.biomerieux.com M. Eric Bourbonnais

[email protected]‐336‐7321

DETECTION:Amplifies, detects and identifies genetic sequences from biological, regardless of genetic composition (RNA/DNA) of targeted agent.Gram positive and negative bacteria, enveloped and non‐enveloped viruses, and yeast all at the same time. Several panels covering the most common types of infections (Respiratory, Gastro‐intestinal, Bloodstream, Meningitis/Encephalitis (in development).

CLOSED SYSTEM

MULTIPLEXEDScreens minimum of 10 targets in single sample, single run. eg. Current respiratory panel detects 22 targets.

SAMPLES:Blood, nasopharyngeal swab, stool, CSF.200‐300µl (panel dependent)Sample transferred in sample buffer. Purity not required, extraction/purification carried on‐board.

Cost/unit: $50,000.00 (CAD)

DESCRIPTION:• Fully automated system integrates cell lysis, nucleic acid extraction/purification/reverse

transcription/amplification, detection/identification analysis and reporting into a single automated process without user intervention following addition of unprocessed sample into system.

• All‐in‐one, sample to result in about 1 hour• Detection and identification of over 20 targets at the same time, in a single run• Less than 2 minutes of hands‐on‐time per samples.• Consumables can be stored at room temperature. Long shelf life (6 months)• Light (9kg) and compact system (25 x 39 x 17 cm). • Syndromic approach covering the vast majority of pathogens associated to an infection.• Very easy to use. Simple, intuitive and comprehensive software (Windows based).• Complete reports generated in pdf format, for easy analysis and filing.• The system includes internal positive control assays to monitor detection failures.

16.5x25.4x39.3cm9kg

Portable

100‐240V 50/60Hz 0.7‐0.35A AC input.No auxiliary power/battery optionWater/gas not required

Minimal waste, biohazard material contained in pouch.

55


Throughput±60min for complete run + 2 minutes for sample pre‐processing (if required)

POC/PON sample collection/analysisNo‐instrument must be run by laboratory personnel

Cost per runVolume dependent, average $180.00/sample

SignatureSounds able to muteScreen light able to dimThermal output N/A*bead‐beater apparatus high‐pitch noise (whine) during first minute of

operation.

Battery/ Auxiliary PowerN/A

Environmental‐15°C to 30°C @ 20‐80% humidityElevation ‐16m to 3098mIndoor use only

MaintenancePeriodic cleaning of surface, bar code reader window and pouch loading sectionPreventative maintenance performed every 1000 tests.

Warranty1 year warranty, can be returned for repair, 14 day turnaround

Lifespan5years

Operational Timing18 steps

Decontamination/CleaningN/A between tests, reload analyzer between tests with new pouch.Loading station should be decontaminated (bleach/water) between samples. Can be done during run.

Other Equipment requiredNo, comes with loading station, desktop computer, USB key.Consumable pouches, panel specific. Store @room temp, include pipettes, syringes, loading buffer and hydration solution.

Training/Ease of UseEasy to use – 4 hour training provided by Field Application Specialist.

Results ReportingPositive/NegativePdf report

Sensitivity/SpecificityPanel specific (Eg. DSe 95%, DSp 99% respiratory panel)Demonstrated: Bacteria (100‐1,000 CFU/mL)Viruses (10e3‐10e4 PFU/mL)

Regulatory Approval/PatentFDA approved, Health Canada in process, CE marked.BCID, GI & Respiratory assays approved by FDA & CE.Patent ‐ Yes

Readiness LevelCommercialized

New AssaysUnknown, corporate decision

PartnershipsUnknown, corporate decision

FilmArray® bioMerieux Canada Inc.

SELECT CITATIONS:• Multicenter Evaluation of the BioFire FilmArray™ Gastrointestinal Panel for the Etiologic Diagnosis of Infectious

Gastroenteritis. Buss SN, Leber A, Chapin K, Fey PD, Bankowski MJ, Jones MK, Rogatcheva M, Kanack KJ, Bourzac KM. J ClinMicrobiol. 2015 Jan 14.

• Implementation and performance of the BioFire FilmArray® Blood Culture Identification panel with antimicrobial treatment recommendations for bloodstream infections at a midwestern academic tertiary hospital. Southern TR, VanSchooneveld TC, Bannister DL, Brown TL, Crismon AS, Buss SN, Iwen PC, Fey PD. Diagn Microbiol Infect Dis. 2015 Feb;81(2):96‐101.

• Rapid Identification of Microorganisms from Sterile Body Fluids by Use of FilmArray. Altun O, Almuhayawi M, Ullberg M, Özenci V. J Clin Microbiol. 2015 Feb;53(2):710‐2.

• Prospective assessment of FilmArray® technology for the rapid identification of yeast isolated from blood cultures. Desoubeaux G, Franck‐Martel C, Bailly É, Le Brun C, Gyan E, Goudeau A, Chandenier J, Lanotte P. J Microbiol Methods. 2014 Nov;106:119‐22.

56

Accutas Aquila Diagnostic Systems, Inc.

Aquila Diagnostic Systems, Inc.9207 117 StreetEdmonton, Alberta T6G 1S3780‐938‐9207www.aquiladiagnostics.com David Alton

[email protected]

DETECTION:Detects nucleic acid (DNA/RNA) in the future, mRNA via Polymerase Chain Reaction

CLOSED SYSTEM

MULTIPLEXEDScreens 7‐15 in first release

SAMPLES:Blood, saliva, urine, water5‐10µl Purification requirements: NonePreprocessing requirements: Dilution with water


DESCRIPTION:• The Aquila system is a portable diagnostic platform that performs accurate, timely, low cost, and multi‐parameter

testing at the point‐of‐care without the need for highly skilled operators. • The Accutas disposable plastic chip contains an array of independent, microlitre reaction compartments that are filled

with Aquila’s patent‐pending hydrogel. Each compartment is a separate reaction vessel that contains all the reagents required for nucleic acid amplification and determination of the amount and identity of the amplified nucleic acid sequence through laser‐induced fluorescence detection performed on a small volume of raw biological fluid (urine, whole blood, sputum) using a proprietary buffer system without the need for any pre‐analytical or off‐cartridge processing. The functionalized hydrogel is desiccated and rehydrated by the addition of the test sample, providing long‐term, stable shelf life without the need for refrigeration.

• The Accutas detection instrument is a small form‐factor device that has been designed with off‐the‐shelf components and is comprised of thermal, LED, optical and CCD‐based detector components. The small form factor and robust design of the system allow it to be used in the field or in a clinical environment. The final unit will incorporate wireless / GSM capabilities so that the instrument can integrate with medical records databases and global positioning hardware to allow geo‐tagging of data for population and disease surveillance activities. The instrument has low power requirements (12 V) and has been designed for ease of use by unskilled operators with a simple user interface, push button operation, and on board computational capacity.

• The platform is composed of a plastic, disposable cartridge with an array of microliter gel reaction compartments and a portable instrument equipped with a heating device, LED light source, CCD based detector and on‐board control systems.

• Each compartment on the cartridge performs a separate nucleic acid–based diagnostic test on a droplet of blood, urine, saliva, or other bio‐fluid.

• The array of gel compartments allows for multiple, independent molecular diagnostic tests to be performed on a single disposable cartridge.

• Due to its portability, low cost and high speed, the platform is ideally suited for work in the field and in the clinic.

35x 25x40cm<10kg

Portable

110V

57


Throughput8‐15 tests per run, <2hours to results.

POC/PON sample collection/analysis No

Cost per run Variable, dependent on target

SignatureNot provided

Battery/ Auxiliary Power110V, battery equivalent to laptop computer.

EnvironmentalNo known restrictions, tested up to 40°C

MaintenanceUnder development

WarrantyUnder development

LifespanUnknown

Operational Timing20 minutes to set‐up, <2hours to test result.Only step is sample dilution with water.

Decontamination/CleaningConsumables autoclaved, weekly decontamination of instrument.

Other Equipment requiredPlates, tubes, proprietary gel.

Training/Ease of UseEasy to use – minimal training, 1 day

Results ReportingPositive/Negative currently, quantitative in next iteration. Yes/No with PCR data available.

Sensitivity/Specificity/Detection RangeDSe: 85‐99%DSp: 85‐99% Error Margin ~2%Detection range: can test down to 2 malaria parasites per microlitre of blood.


Patent – Yes




Partnerships: Research Collaboration, contract assay development

SELECT CITATIONS:

• Taylor BJ, Howell A, Martin KA, Manage DP, Gordy W, Campbell SD, Lam S, Jin A, Polley SD, Samuel RA, Atrazhev A, Stickel AJ, Birungi J, Mbonye AK, Pilarski LM, Acker JP, Yanow SK. A lab‐on‐chip for malaria diagnosis and surveillance. Malar J. 2014 May 9;13:179.

• Manage D.P., Lauzon J. Atrazhev A., Chavali R., Samuel R.A., Morrissey Y.C., Gordy W., Edwards A.L., Larison K., Yanow S.K., Acker J.P., Zahariadis G., Pilarski L.M. "An enclosed in‐gel PCR amplification cassette with multi‐target, multi‐sample detection for platform molecular diagnostics." Lab Chip 13, 2576‐2584 (2013).

• Manage D.P., Lauzon J., Atrazhev A., Morrissey Y.C., Edwards A.L., Stickel A.J., Crabtree H.J., Pabbaraju K., Zahariadis G., Yanow S.K., Pilarski L.M. "A miniaturized and integrated gel post platform for multiparameter PCR detection of herpes simplex viruses from raw genital swabs." Lab on a Chip 12 (9): 1664‐1671 (2012).

• Manage D.P., Morrissey, Y.C., Stickel, A.J., Lauzon, J., Atrazhev, A., Acker, J.P., Pilarski, L.M., "On‐Chip PCR amplification of genomic and viral templates in unprocessed whole blood." Microfluidics and Nanofluidics 10 (3): 697‐702 (2011).

• Atrazhev, A., Manage, D.P., Stickel, A.J., Crabtree, J.H., Pilarski, L.M., and Acker, J.P. "Hydrogel amplification technology for genotyping and pathogen detection." Analytical Chemistry 82 (19): 8079‐8087 (2010).

Accutas Aquila Diagnostic Systems, Inc.

58

CapSenze 100 CapSenze HB

CapSenze HBMedicon VillageSE‐22381 Lund, Sweden+46 706059830www.capsenz.se Bo Mattiasson

Bo‐[email protected]

DETECTION:Detects nucleic acid sequences, protein using , immuno‐; genetic; molecularly imprinted polymer (MIP); lectin.

OPEN SYSTEM

SINGLE (can be MULTIPLEXED)Screens from 1 to approx. 10,000 bioanalytes. iDiagnostics microarray is flexible, can use single bioassay without internal standards or 10000 microarray spots that include internal standards, calibration, and normalization assays. Typical application, for example, detection of an infectious disease requires from 4 to 32 assays.

SAMPLES:Blood, saliva, urine<100µl Purification N/A Pre‐processing – None, dilution

FULLY AUTOMATED


DESCRIPTION:• Simple, Sensitive, Automated• CapSenze Biosystem is a stand alone affinity‐based sensor which allows for automatic analysis of the

target analyte of interest. After placing the specific sensor electrode (e.g. towards endotoxins, host‐cell proteins, cholera toxin, p24 antigen) the analysis is automatically performed without any operator‐involvement.

• Based on standard curve calibration, the read‐out allows for quantification of the target, typically in the range from attomolar to nanomolar in concentration.

• Commercialized for certain applications.• Use of MIPs eliminate need for cold drain.

25x40x30cm12kg

Portable

220V power required. 24V battery/120 samples

59


Throughput15 minutes


Cost per run $10.00 + consumables

SignatureNo detail provided

Battery/ Auxiliary Power220V power required. 24V battery/120 samples

EnvironmentalNo detail provided

MaintenanceMonthly maintenance, pump cleaning recommended

Warranty1 year warranty on hardware.

Lifespan5‐10 years

Operational Timing3‐5 steps, dilution and infusion of sample, then directly to platform. Set up steps, clean and calibrate pump and valves, mount the chip.

Decontamination/CleaningRegeneration of electrode surface between every analysis (20 min)

Other Equipment requiredBuffer and electrode chip.Buffer needs to be sterile, storage 6 months to 2 years. biomolecules storage at 8°C, MIPs at ambient temp.

Training/Ease of UseEasy to use – short introduction required

Results ReportingQuantitative reporting presented in datafile, both with calibration curve and raw data.

Sensitivity/Specificity/Detection RangeDSe 10‐18‐10‐16 M9LOD) DSp depends on capture moleculeError margin ±5%.Detection Range 10‐18‐10‐12; dynamic range.

Regulatory Approval/PatentUnder preparation, other devices have ongoing collaboration with FDA.

Patent – Yes

Readiness Level – Pre‐Clinical/In‐House Testing



Partnerships: Collaboration; Commercialization; Developmental

SELECT CITATIONS:• Use of a capacitive affinity biosensor for sensitive and selective detection and quantification of DNA—A model

study. Mahadhy A, Hedström M, Ståhl‐Wernersson E, Mattiasson B. Biotech Rep. 2014 Sep; 3: 42‐48.• Microcontact‐BSA imprinted capacitive biosensor for real‐time, sensitive and selective detection of BSA. Ertürk G,

Berillo D, Hedström M, Mattiasson B. Biotech Rep. 2014 Sep; 3: 65‐72.• A capacitive DNA sensor‐based test for simple and sensitive analysis of antibiotic resistance in field setting. Liu Y,

Hedström M, Chen D, Fan X, Mattiasson B. Biosens Bioelectron. 2015 Feb 15;64:255‐9. • Immunochemical binding assays for detection and quantification of trace impurities in biotechnological production.

Mattiasson B, Teeparuksapun K, Hedström M. Trends Biotechnol. 2010 Jan;28(1):20‐7.• Sub‐attomolar detection of cholera toxin using a label‐free capacitive immunosensor. Loyprasert S, Hedström M,

Thavarungkul P, Kanatharana P, Mattiasson B. Biosens Bioelectron. 2010 Apr 15;25(8):1977‐83.• Ultrasensitive detection of HIV‐1 p24 antigen using nanofunctionalized surfaces in a capacitive immunosensor.

Teeparuksapun K, Hedström M, Wong EY, Tang S, Hewlett IK, Mattiasson B. Anal Chem. 2010 Oct 15;82(20):8406‐11

CapSenze 100 CapSenze HB

60

Ziplex® System Axela, Inc.

Axela, Inc.50 Ronson DriveToronto, Ontario M9W 1B3416‐798‐1625www.axela.com Paul Smith

[email protected]

DETECTION:Proteins (antigens and antibodies) and nucleic acids (RNA and DNA) via hybridization and chemiluminesence. Demonstrated in brain injury markers, sepsis, pathogen screening (bacteria, virus, fungi), blood safety (HIV), parasitology, oncology and allergy.

OPEN SYSTEM

MULTIPLEXEDCan simultaneously test up to 576 targets, typically takes quadruplicate measurements of 100‐125 biomarkers.

SAMPLES:Serum, plasma, whole blood, saliva, nasal aspirates, urine, tissue lysates.2‐15µl Pre‐processing – None for liquid samples, tissue must be homogenized and lysed. Nucleic acid analysis sample extraction and amplification prior to detection integral to cartridge.

Cost/unit: $5000.00 (CAD)

DESCRIPTION:• Axela has a bench top analyser for both proteins and nucleic acids and is developing a point of use

version of the technology. This is a fully automated cartridge based, sample to answer instrument.• Adaptable to a broad range of assays including serology, ELISA, gene expression, DNA/RNA hybridization,

CNV.• The platforms are designed to accommodate a wide variety of assay types and Axela’s business model is

one of co‐development for new assays.Key advantages of flow through array technology include:• Rapid binding by overcoming diffusion limitations leads to rapid and highly sensitive assays.• Critical pressure phenomenon greatly simplifies instrument design ( no syringes or volumetric control).• and allows low cost, molded disposable cartridge ( no moving parts).• Use of chemiluminesence eliminates laser light sources, alignment issues, simple CCD camera with low

power consumption.• Common platform for nucleic acids and proteins, flow through substrate also used for integrated rapid

extraction and amplification of nucleic acids.

Single cartridge platform: 15.2x20.3x25cm

Four bay cartridge system:30.5x30.5x45.7cm

13kg

PortableCartridge instrument can be modified for

certain handheld applications.110/220V power or battery supply

61


Throughput15 minutes to result for protein assays, up to 60 minutes for high sensitivity pathogen detection from whole blood.

POC/PON sample collection/analysis Yes, certain assays compatible with POC (finger prick, blood cards)

Cost per run $5.00 protein assays, $10.00 nucleic acid assays.

SignatureNot provided

Battery/ Auxiliary Power110/220V power or battery supply, no other services required.

EnvironmentalDesigned for operation in 10‐45°C Relative humidity 20‐85%Consumables currently planned for refrigerated storage, freeze dried and room temperature reagent storage under development.

MaintenanceNone

WarrantyNot provided

Lifespan5 years

Operational TimingSet up <2 minutes, downtime between runs 2 minutes.

Decontamination/CleaningDisinfectant wipes externally, insert sanitation cartridge for automated internal protocol.


Training/Ease of UseEasy to use – minimal training

Results ReportingQualitative and quantitative results assay dependent. Visual screen plus standard lab interfaces for communication.

Sensitivity/Specificity/Detection RangeDSe/DSp are assay dependent. Typical CV’s for quantitation are 5‐7%.Demonstrated sensitivity examples include low femtogram/ml range for proteins, <10 copies /ml forviruses, single femtomolar detection of RNA, 4 logs of instrument dynamic range

Regulatory Approval/PatentDeveloped under ISO 13485 guidelines, CE mark expected 2016Patent – Yes

Readiness Level – Clinical trial use, used in CLIA regulated environments.



Partnerships: Business model is one of co‐development of new assays, including design of customer specific instruments, adaptation of assays to existing or partner instruments that use Flow Through Array technology.

Ziplex® System Axela, Inc.

Multiplex infectious disease panels• Program to validate tests initially with lab partners as LDT’s• Leverages low cost multiplex, high sensitivity and automation• Both nucleic acid and protein tests on same platform• Allows most comprehensive coverage

Fungal: Histo/Blasto/Cocci protein based on proprietary “gold standard” antigens being validated in CLIA laboratory. Comprehensive menu to include antigens, antibodies and nucleic acid based identification and resistance monitoring.

Vaccine status: 7 plex panel based for deployment with national reference lab partners, compatible with both blood draw and consumer self sample.

Parasitology: Partnership with Canadian National Reference Laboratory to validate parasitology assays for routine screening.

62

BD Accuri™ C6 Flow Cytometer BD (Becton Dickinson)

BD2100 Derry Road West, Suite 100Mississauga, Ontario L5N 0B3905‐288‐6197www.bdbiosciences.com/ca Neil Soriano

[email protected]

DETECTION:Detects any biomarker labeled with fluorochromeconjugated antibody. Uses fluorescence detection and quantitation. Up to four fluorochromeconjugated antibodies are incubated with sample and analyzed on a flow cytometer to detect fluorescence intensity.

OPEN SYSTEM

SINGLE/MULTIPLEXEDCan detect four simultaneously.

SAMPLES:Variable, typically whole blood, serum, plasma.250‐500µl concentration dependent.Pre‐processing – incubation with fluorochromeconjugated antibodies against desired markers.

SEMI AUTOMATED


DESCRIPTION:• Easy to use, wide range of assays, transportable.• The BD Accuri™ C6 personal flow cytometer brings immunology and stem cell studies to the benchtop.

With two lasers, two scatter detectors, and four fluorescence detectors, it can handle most common assays with ease.

• Absolute counts. Cell concentration can be calculated directly from BD Accuri™ C6 software statistics tables without the addition of counting beads.

• Its compact footprint and portable weight make it a valuable personal use tool for both novice and experienced researchers who want a cytometer to be easily available when and where they need it.

• The system features an intuitive software interface, software templates, and reagent kits that guide users new to flow cytometry through workflows for popular applications.

28x54.6x42cm13.6kg

Portable

110V, 50/60 Hz

63


ThroughputPre‐processing 20‐30 minutes, sample acquisition and data analysis 30‐60 seconds per sample.Single tube tests; use of 24 tube autoloader; use of 96 well autosampler.


Cost per run Variable‐ $2.00 to $22.00

SignatureSounds able to muteScreen light able to dimThermal output 240 BTU/hour maximum output.

Battery/ Auxiliary PowerAuxiliary power can be used, duration unknown.

EnvironmentalOperating range 15‐30°C, <50% relative humidity.Consumables at 4°C

MaintenanceDaily clean on shutdown; regular monthly maintenance.

Warranty1 year manufacturer warranty, extended available $4700/yr.

LifespanVariable

Operational Timing2‐8 steps, variable and assay dependent. Addition of fluorochrome conjugated antibody to sample, incubation, acquisition on platform.

Decontamination/CleaningNone required between tests

Other Equipment requiredDI water, fluorochrome conjugated antibody, sample lysing and washing solution, 12x75mm tubes, or 96 well plates.

Training/Ease of UseEasy to use

Results ReportingQuantitative results. Data copy/pasted into MS Excel, Word, PowerPoint or can be exported as .fcs files for analysis on 3rd party software.

Sensitivity/Specificity/Detection RangeUnknown DSe, DSp, Error Margin5pg to 5000pg quantitative range. Variable.

Regulatory Approval/PatentNo – BD FACSCanto II (2005/HC) has been approved.Patent – No




Partnerships: Assay development for use in Accuri.

SELECT CITATIONS:• Evaluation of an easy and affordable flow cytometer for volumetric haematopoietic stem cell counting. Mariani M,

Colombo F, Assennato SM, Frugoni C, Cattaneo A, Trombetta E, Rebulla P, Porretti L.Blood Transfus. 2014 Jul;12(3):416‐20.

• Platelet counting with the BD Accuri(TM) C6 flow cytometer. Masters A1, Harrison P. Platelets. 2014;25(3):175‐80.

BD Accuri™ C6 Flow Cytometer BD (Becton Dickinson)

64

pTDi Bruker Daltonik GmbH

Bruker Daltonik GmbHPermoserstrasse 15Leipzig, Germany 04318+49 341 2431 366www.bruker.com Dr. Thomas Elssner

[email protected]

DETECTION:Detects Proteins; extension to metabolite (low molecular weight substances) and RNA detection is feasible; in general also PCR‐based amplification of DNA signature sequences and hybridization based detection of amplification products is possible for pathogen identification. Uses immunological detection; additional module for (RT)‐PCR‐based amplification of RNA biomarkers is in development

OPEN SYSTEM

MULTIPLEXEDScreens 5 biomarkers (each in duplicate) + positive control (triplicate) + negative control (triplicate), i.e. 16 independent positions; extension to 64 positions in development.

SAMPLES:Blood, saliva, urine500µlPurity requirements: NonePre‐processing requirements: Addition of sample buffer and filtration through syringe filter.

FULLY AUTOMATED

Cost/unit: $50,000.00 (Euro ‐ $~67,700.00 CAD)

DESCRIPTION:• The pTDi is a self‐contained identification platform for automated and specific detection of biological toxins

associated with biological warfare agents (BWA).• The detection principle is based on an enzyme‐linked immunosorbent assay (ELISA) procedure. Antibodies

immobilized on gold electrodes attached to a toxin chipstick facilitate the specific capture of corresponding toxins from an applied liquid sample. Detection of captured toxins is realized by measuring the electrical current of an enzymatic redox reaction. The current correlates to the amount of target molecules bound to the specific antibodies. The whole identification procedure is realized in less than 25 minutes.

• Parallel detection of five toxins, which are relevant as BWA• Ready‐to‐use kits for assay performance• Plug and play operation using disposable chipsticks• Ready for integration into sensor networks• Extendable system to address new biological threat agent

41x31x40cm15.3kg

Portable (willingness to modify to handheld)

19 V DC (power supply 220V).

65


Throughput1 sample per run. Assay time 20 min, separate sample pre‐processing ~3 min.


Cost per run Assay dependent. 10.00‐100.00 EUR ($13.50‐$135.00 CAD)

SignatureScreen light able to dim Thermal output 239 BTU/hr

Battery/ Auxiliary Power19 V DC (power supply 220V). 15 tests/charge.

EnvironmentalStorage temperatures ‐40°C to 70°COperating temperatures 10°C to 37°CRelative humidity up to 80%Consumables 2‐8°C for up to 9 months.

MaintenanceTest performance of system every 3 months using pTDTraining kit. No other maintenance required.

Warranty1 year warranty of fluidic parts, 2 years for electronic parts.

Lifespan>5 years

Operational Timing<1 min to set up. Start pTD Control software, initialization, choose assay. 4 min decontamination time between tests, 7 min system wash at start of new day.

Decontamination/CleaningAutomated decontamination step included in assay procedure (approx. 4 minutes after measurement); decontamination of housing.

Other Equipment requiredAll necessary additional equipment (tablet PC including pTD Control Software, pipette, pipette tips, shaker) are supplied within an accessory suitcase.

Training/Ease of UseEasy to use – no specific training required

Results ReportingPositive/Negative and Quantitative results are displayed in pTD Control software on a fieldable tablet PC: overview (target analyte and positive/negative), quantitative results of each position and graph (current vs. assay time) are displayed; report file is automatically saved after each measurement; ICD (Interface Control Document) available.

Sensitivity/Specificity/Detection RangeDSe: 95‐98% DSp: >98% in majority of targets Limit of detection for protein analysis in pg/mL range to low ng per mL range (using a total assay time of 20 minutes); detection range from high pg per mL to low µg per mL; dynamic (quantitative) range from approx. 1‐10 ng per mL to 10‐100 ng per mL.

Regulatory Approval/PatentNo regulatory approvalPatent – Yes




Partnerships: Vertical partnerships with development of new assays based on immunoassay principle, development of assays for direct detection of RNA biomarkers, improvement of assay performance investigations, development of clinical assays for detection of host‐specific biomarkers, investigation of hardware improvements to develop a hand‐held device.

SELECT CITATIONS:• Schreiber T, Wijayawardhana C, Mascher C, Lassen S, Pauly D, Piechotta G, Dorner MB, Hintsche R, Wörl R, Dorner BG (2010)

Detection of potential biowarfare agents using an automated and field‐deployable microarray platform. 20th anniversary world congress on biosensors, Glasgow.

• Pöhlmann C, Hansbauer EM, Skiba M, Bellanger L, Ezan E, Dorner BG, Elßner T (2015) Multiplex detection of biothreat agents applying a fully automated electrochemical biochip platform for use in the field. ASM Biodefense 2015, Washington, DC.

• Elßner T, Pöhlmann C, Hansbauer EM, Skiba M, Bellanger L, Ezan E, Dorner BG (2015) On‐site multiplex detection of category A and B biothreat agents. CBRN Research & Innovation, Antibes, France.

• Pöhlmann C, Elßner T (2015) Field based multiplex detection of biothreat agents. NBC 2015, Helsinki, Finland.• Schreiber T, Hansbauer EM, Mascher C, Pöhlmann C, Lassen S, Piechotta G, Wijayahwardhana C, Wörl R, Hintsche R, Elßner T,

Dorner MB, Dorner BG (2015) Multiplex detection of biological toxins in complex matrices using a portable electrochemical biosensor. Manuscript in preparation.

pTDi Bruker Daltonik GmbH

66

MAGPIX® Instrument Luminex Corporation

Luminex Corporation12212 Technology Blvd.Austin, Texas 78727512‐348‐2386www.luminexcorp.com Matthew Lesho

[email protected]

DETECTION:Detects Nucleic Acid (DNA and RNA, including pathogen ID, genetic subtyping, gene expression, etc), Protein (including serological, cytokines), small molecule metabolites and antigens via xMAPplatform using microbead capture and digital fluorescence microscopy.

OPEN SYSTEM

MULTIPLEXEDScreens 50+ simultaneously

SAMPLES:Blood, Nasal and throat swabs, Stool, Urine, Wound, Environmental air, Environmental water, Soil, Food.10µl to 1000µl, varies by assayPurity requirements: Raw clinical, food, environmental.Pre‐processing requirements: minimal

SEMI AUTOMATED


DESCRIPTION:• The MAGPIX Instrument uses the xMAP®(Multi‐Analyte Profiling) platform that uses encoded microbeads to

capture analytes, which are then labeled and read using simple, robust digital fluorescence microscopy. Numerous types of biomarkers can be detected with this system. Nucleic Acid (DNA and RNA, including pathogen ID, genetic subtyping, gene expression, etc), Protein (including serological, cytokines), small molecule metabolites and antigens. Roughly 23,000 peer reviewed publications have been published on the platform.

• Many types of ligands or recognition molecules can be coupled to the beads to detect a wide variety of biomarkers. The most common capture molecules used are nucleic acid probes (for molecular testing via NA hybridization), antibodies (for immunoassays), and antigens (for serological detection of antibodies). Less common capture molecules are DNA aptamers, lectins, and other binding proteins.

• The Luminex xMAP platform and the MAGPIX specifically is uniquely positioned to be the most efficient, cost effective, and versatile multiplex assay solution for clinical diagnostics, biosurveillance, environmental monitoring, biodefense, food safety, and animal health, and life science research.

• High performance multiplexed molecular assay capability, with broad menu of RUO and IVD cleared assays (viral, bacterial, parasitic, and fungal infectious disease detection, as well as gene expression, genotyping, etc.).

• High performance immunoassay capability (biomarkers, toxins, cytokines, etc.), High throughput potential (96‐well format).

• Open Platform (allowing lab developed tests), with Applications Support available.• Comprehensive quality systems associated with IVD manufacture and marketing.• Extensive partnerships that expand assay menu.• Modest Footprint; User Installed, operation with minimal training required. • World‐class technical support. • Culture of continuous improvement and innovation. New technologies are in late stage development to reduce

workflow steps and add assay menu, while maintaining cost‐effectiveness and open‐platform approach.

43x16.5x60cm18kg

Portable (travel case available)

100‐120 or 200‐240 VAC and 50‐60Hz.

67


Throughput96 well format. As little as 1‐1.5 hrs to 4‐5hrs for first result, but further results follow at 1/minute (up to 96 results/plate)


Cost per run Assay dependent. Multiplex biothreat panel (Bot A, B, E, F, ricin and SEB) $2400.00/100 samples (discounts for higher volume)

SignatureSounds able to mute (via PC)Screen light able to dim (via PC)Thermal output ‐ ~40 watts power output.

Battery/ Auxiliary Power100‐120 or 200‐240 VAC and 50‐60Hz, UPS (uninterruptable power source) may be recommended, UPS size to complete 96‐well plate.

EnvironmentalOperating temperatures 15°C to 35°CRelative humidity 20‐80%, noncondensingCAL/VER kits/bead mix 4°C

MaintenancePeriodic calibration and verification procedures using standard reagents from Luminex. 6 and 12 month preventative maintenance (change tubing assemblies, fluid, air filters and gaskets)

Warranty1 year warranty, extension via service contract

Lifespan>10 years

Operational TimingApprox. 15 minutes, to set‐up, 4 steps. Physical set‐up and PC connection, systems turn‐on and calibration, system verification, protocol and batch selection for particular assay. 96 plate assay in approx. 1‐2hrs. 5 min to clean and prepare subsequent batches.

Decontamination/CleaningNo manual steps, automatic decontamination protocols.

Other Equipment requiredMAGPIX reagents (CAL/VER kits, Drive fluid), Common Lab reagents (DI water, isopropanol, bleach, 0.1 N NaOH). Plasticware (Plates, pipette tips, etc.). Magnetic plate rack, Thermal block

Training/Ease of UseSomewhat easy to use – online tutorial included on PC

Results ReportingPositive/Negative and Quantitative results into .CSV file, to be viewed manually or imported into a data analysis software program to automate assay calling. The system can run assays in +/‐ (qualitative) format (e.g. an infectious disease test), quantitative format (e.g. cytokine assays), or “allele call” format (e.g. inherited disease genotyping assay). Can interface with LIMS systems and also has a “remote monitoring” capability to observe results in real time from a web‐based interface.

Sensitivity/Specificity/Detection RangeDSe: >90% DSp: >98% in majority of targets Error Margin: 95% confidence. Optics measure 3.5 decades of dynamic range, correlating to rough 3‐4 orders of magnitude dynamic range in analyte of interest.

Regulatory Approval/PatentFDA/Health Canada/EMA ApprovedPatent – Yes




Partnerships: Actively engaged in partnerships with US Government and private industry in assay development, instrument development, assay manufacturing/QC.

SELECT CITATIONS:• Over 23,000 publications in the peer reviewed literature. Searchable at www.luminexcorp.com/publications/

MAGPIX ® Instrument Luminex Corporation

68

LightCycler® 2.0 Roche Diagnostics

Roche Diagnostics201 Armand‐Frappier Blvd.Laval, Quebec, H7V 4A2800‐667‐2547www.rochecanada.com Stéphanie Pagé

[email protected]

DETECTION:Detects nucleic acids (DNA/cDNA/RNA) via Real Time Polymerase Chain Reaction: genetic, infection, disease.

OPEN SYSTEM


SAMPLES:Blood, saliva, urine.Capillaries volume= 20µl or 100µl, sample 5µlPurity requirements: Varies per test.Pre‐processing requirements: Extract DNA, if RNA, convert to cDNA.

SEMI AUTOMATED


DESCRIPTION:• Fast and sensitive real‐time PCR and RT‐PCR• Reproducible and reliable kinetic quantification of DNA, cDNA, or RNA is possible without performing amplification• Easy PCR product identification and characterization by melting point analysis• Highly specific mutation analysis and SNP (Single Nucleotide Polymorphism) genotyping• Multiple reaction volumes provides flexibility in development of user‐defined applications using either 100 uL or

20 uL capillaries.• Six fluorescence detection channels allows flexibility in the selection of detection chemistries that may be utilized

in the development of user‐defined applications.• Easy navigation to automate analysis for routine testing or customize the settings as needed. Creates experimental

protocols quickly by utilizing user‐defined templates and macros.• Performs qualitative detection, absolute and relative quantification, along with melting curve analysis for

streamlined data evaluation.• Protects user‐defined protocols to simplify use for everyone in the lab, resulting in improved data integrity and

reproducibility. Tracks user actions with available audit trail.• Automatically defines the optimal primers and probes for various Real‐Time PCR applications.• Automated analysis and scoring of sequences according to the design parameters.• Import sequence data and select design parameters for your specific applications.• Proven performance from Roche, the LightCycler® 2.0 instrument allows you to monitor amplification of 32 PCR

products simultaneously, in real‐time and online, with six different detection channels.

50.5x28x38.5cm22kg

Portable

110V power, Auxiliary power can be used

69


Throughput32 tests per run. Approx. 45 minutes (user configurable and based on test method)


Cost per run Approx. $3.15 per reaction, based on test.


Battery/ Auxiliary Power110V power, Auxiliary power can be used, dependent on quality of electrical grounding, UPS (uninterruptable power source) may be required.

EnvironmentalOperating temperatures 18°C to 30°CRelative humidity 20‐80%<2000m above sea level (850‐1050hp)

MaintenanceMaintenance free

Warranty1 year warranty, extension via service contract

Lifespan>10 years

Operational TimingApprox. 5 minutes, a “Plug and Play” instrument.Downtime between runs is <2 minutes.

Decontamination/CleaningNone required.

Other Equipment requiredLC carousel Centrifuge and Vortex Mixer

Training/Ease of UseEasy to use – Software training, approx. 4 hrs

Results ReportingPositive/Negative and Quantitative displayed on proprietary format; data can be exported to CSV and Excel files.

Sensitivity/Specificity/Detection RangeDSe/DSp ‐ Test/method dependent, specific package inserts can be provided.

Regulatory Approval/PatentFDA/Health Canada ApprovedPatent – Yes




Partnerships: Always open to partnerships for innovation. Eg: 2009 external collaboration led to development, testing and commercializing of H1N1 test in short period of time.

SELECT CITATIONS:• (2002); LightCycler ‐ Hepatitis A Virus Quantification Kit ‐ A New Tool for Virus Genome Quantification on the

LightCycler Instrument and the MagNa Pure LC Instrument; Biochemica; 12‐12;• (2010) Analytical performance determination and clinical validation of the novel Roche RealTime Ready Influenza

A/H1N1 Detection Set. J.Clin Microbiol. 2010 Sep;48(9):3088‐94• Böll I;Ebenbichler C;Ankenbauer W; (2004); Establishing Multiplex PCR Assays Using the New LightCycler Multiplex

DNA Master HybProbes and the LightCycler 2.0.Instrument; Biochemica; 4‐5;• Clarici AKM;Mühlbauer G;Stelzl E;Marth E;Kessler H (2001); Detection of Herpes Simplex Virus (HSV) in Research

Applications by the MagNA Pure LC and the LightCycler System; Biochemica; 7‐8;• Gaede W; (2002); Detection of Classical Swine Fever with the LightCycler Instrument; Biochemica; 4‐6;• Noppen C;Martinato I;Reischl U;Schaefer C; (2001); High‐Speed Purification and Detection of Bordetella Pertussis ‐

A Straight‐forward Application for MagNA Pure LC and the LightCycler System in Microbiological Research; Biochemica; 17‐19;

• Tobisch S;Koburger T;Jürgen B;Leja S; (2003); Quantification of Bacterial mRNA by One‐Step RT‐PCR Using the LightCycler System; Biochemica; 5‐8.

LightCycler® 2.0 Roche Diagnostics

70

LuBEA® Precision System Science USA, Inc.

Precision System Science USA, Inc.5673 W Las Positas Blvd Suite 202Pleasanton, California 94588925‐960‐9183 (cell) 925‐487‐1416www.pss.ca.jp/product/product/details‐device‐21.html (Japanese) Chris Kusumoto

[email protected]

DETECTION:Detects allergy, oncology marker, cardiac failure, clinical testing, autoimmune, pharmacogenomics, immunodeficiency, neonatal screening, genetically modified food, food allergens, protein, GMO, genes via immunological and genetic chemistry.

CLOSED SYSTEM

MULTIPLEXEDScreens approximately 20 markers simultaneously.

SAMPLES:Whole blood, tissue, serum, plasma, hair, food, stool, water, stained blood in paper 10‐1000µl Purification ‐ N/A Pre‐processing – hair/tissue/stained blood in paper requires pre‐treatment

FULLY AUTOMATED


DESCRIPTION:• LuBEA has been developed as an automated reaction‐detection instrument for BIST, which is a multiplex detection

tool. BIST® technology, (Beads‐array‐In‐Single‐Tip) technology, is a signal detection technology of measuring multi‐items up to 20 items simultaneously.

• Used together with BIST as the detection tool, LuBEA enables development of automated reaction protocols and combined with pre‐packed reagents, enables automated process of reaction, washing and detection. Only setting BIST, sample and pre‐packed reagents realizes to get measurement result without intervention of manual steps.

• The automated system has a common structure for various tests, and it is easily used for tailor maid care by genetic polymorphism, laboratory test, or food manufacturing.

• BIST is a capillary tip‐shaped tool that encloses 1mm diameter beads; with each of the beads immobilized with different DNA probes or antibodies, multiplex detection and analysis can be realized. This capillary can aspirate/dispense liquid and combined with LuBEA enables multiplexed detection and fully automated reactions. Using BIST reduces sample and reagent volumes.

• Further efficient agitation of liquid speeds up reaction steps.• Fully automated multiple analyzer; Fully‐automated sample to answer system; Pre‐packed reagents

cartridge with tips; High‐sensitive chemiluminescence detection by PMT; Simple operation; Small size , light weight

• Up to 20 probes can hybridize with sample, and it reduces time and reagent volume. • Proven DNA extraction technology with magnetic beads by which we have manufactured 15000 instruments• OEM customers such as Roche and Qiagen, and you may use a superb quality of extracted DNA.

40x17x49cm22kg

Portable

AC.100V ～240V 50/60Hz max.130VANo battery or auxiliary power.

71


Throughput1 sample per run, 10 minutes to 2.5 hours dependent on assay type.


Cost per run Dependent on detected target.

SignatureSounds able to muteScreen light able to dimThermal output 443 BTU/hour

Battery/ Auxiliary PowerAC.100V ～240V 50/60Hz max.130VANo battery or auxiliary power.

Environmental5°C to 40°C @ ~80% humidityElevation ‐~2000mPlastics stored at 5°C to 40°C , reagent at room temp.

MaintenanceTwice per year maintenance. Calibration of axes positions and photo detection unit.

Warranty1 year warranty included. Extended $3‐5000/yr.

Lifespan5 years

Operational Timing3 steps, 5‐15 minutes. Set up assay information on GUI; place consumables, reagent and sample; press ‘start’. Tissue/hair/stained blood in paper needs pre‐treatment. Rebooting not necessary.

Decontamination/CleaningMinimal, end of day cleaning with 70% alcohol.

Other Equipment requiredExternal PC with software, reagent, capillary tip filled with 1mm diameter beads immobilized with antibody/DNA.

Training/Ease of UseEasy to use – training not required

Results ReportingQuantitative results. Level of fluorescence or chemiluminescence count measured by Photo Multiplier Tube.

Sensitivity/Specificity/Detection RangeTarget dependent


Patent – Yes




Partnerships: Can provide LuBEA, consumables (tip and blank reagent cartridge) and beads on which you immobilize a probe, and you use your own reagent, pack your reagent into a cartridge with aluminum foil for yourself, and develop your own protocol , to maximum degree that we provide LuBEA, consumables, pre‐filled reagent cartridge, beads on which we service to immobilize a probe, and develop a protocol. Also we have a proven DNA extraction technology using magnetic beads, and we can provide a superb DNA extraction instrument.

SELECT CITATIONS:• Automated enzyme‐linked immunosorbent assay using beads in a single tip (BIST)

technology coupled with a novel anchor protein for oriented antibody immobilization. Ikeda T, Ueda T, Tajima H, Sekiguchi S and Kuroda A. Anal. Methods, 2014, 6, 6232.

LuBEA® Precision System Science USA, Inc.

72

geneLEAD1 Precision System Science USA, Inc.

Precision System Science USA, Inc.5673 W Las Positas Blvd Suite 202Pleasanton, California 94588925‐960‐9183 (cell) 925‐487‐1416www.pss.ca.jp/product/product/details‐device‐20.html (Japanese) Chris Kusumoto

[email protected]

DETECTION:Detects virus/bacteria, mRNA profiling, SNP typing, mutation detection via genetic chemistry.

CLOSED SYSTEM

MULTIPLEXEDScreens 6 markers simultaneously.

SAMPLES:Whole blood, tissue, serum, swab, urine, plasma10‐1000µl Purification – fresh sample desiredPre‐processing – tissue needs to be filtrated.

FULLY AUTOMATED


DESCRIPTION:• Flexible and fully automated sample to result platform.• Ease of use

• Fully automated nucleic acid extraction, PCR setup and real‐time PCR• Prefilled‐nucleic acid extraction reagent and Prefilled‐PCR reagent• Universal design of nucleic acid extraction reagent

• Flexibility for reaction setup• For up to 12 samples/run (1.5‐2.0 hr/run)• Multiplex PCR capability within single run: Up to 6 fluorescence detection channels and independently

controlled PCR unit• Single nozzle dispenser

• Other platforms often lack of nucleic acid extraction capability so that a customer needs manual extraction, but our geneLEAD1 has a proven DNA extraction + amplification capabilities.

• Precision System Science has so far manufactured 15000 DNA extraction instruments using magnetic beads to OEM customers such as Roche (MagNA Pure)and Qiagen (EZ1).

65x17x59cm25kg

Portable

AC.100V ～240V 50/60Hz max.130VANo battery or auxiliary power.

73


Throughput1 test per run, DNA extraction 3‐45minutes, PCR 60‐75 minutes = Total 1.5‐2 hours.


Cost per run ~$10.00 (USD)

SignatureSounds able to muteScreen light able to dimThermal output 683 BTU/hour

Battery/ Auxiliary PowerAC.100V ～240V 50/60Hz max.130VANo battery or auxiliary power.

Environmental5°C to 40°C @ ~80% humidityElevation ‐~2000mPlastics (tips, tubes stored at 5°C to 40°C , Pre‐filled nucleic acid extraction reagent cartridge at room temp. PCR reagents ‐20°C to 8°C, humidity ~80%

MaintenanceTwice per year maintenance. Calibration of motion axes positions and PCR heater/cooler.

Warranty1 year warranty included. Extended $3‐5000/yr.

Lifespan5 years

Operational Timing3 steps, 5‐15 minutes. Set up assay information on GUI; place consumables, reagent and sample; press ‘start’. Tissue sample needs to be filtrated. Rebooting not necessary.

Decontamination/CleaningUsed tip is returned into tip sheath. End of day, clean stage with 70% alcohol.

Other Equipment requiredExternal PC with software included, consumable (tip, tube, reagent cartridge)

Training/Ease of UseSomewhat easy to use – specific training not required

Results ReportingQuantitative results. Level of fluorescence displayed in graph and as data value.

Sensitivity/Specificity/Detection RangeTarget dependent


Patent – Yes




Partnerships: Can provide pre‐filled package of nucleic acid extraction reagent with magnetic beads, and you provide PCR reagent. Or you provide both nucleic acid extraction and PCR reagents. We have a service to pack reagents into a cartridge with aluminum foil, or you may pack nucleic acid/PCR reagents into a reagent cartridge for yourself. We provide plastics (tip, reagent cartridge) because they precisely fit our instrument. For protocol development, if you useour nucleic acid extraction reagents, we provide the protocol. For PCR part, you need your protocol, and we provide a software tool

SELECT CITATIONS:• Flexible and fully‐automated sample to result PCR system ‘geneLEAD XII plus and geneLEAD I plus’. Ueda T, Hilliker

C and Tajima H. SLAS 2014

geneLEAD1 Precision System Science USA, Inc.

74

NESDEP® IU F Cubed, LLC

F Cubed, LLC1441 N. Michigan Street, Suite 2000South Bend, Indiana 46617574‐234‐2611www.fcubed.biz Leslie T.Ivie

[email protected]

DETECTION:Detects nucleic acids (DNA/RNA) and proteins via AC Dielectrophoresis in a CNT‐based biochip

CLOSED SYSTEM

SINGLE

SAMPLES:Any fluid, blood, wound product150mLPurity requirements: NonePre‐processing requirements: None, platform performs all sample prep.

SEMI AUTOMATED

Cost/unit: $50,000.00

DESCRIPTION:• Molecular Detection Through AC Dielectrophoresis• “One‐Click” Assay – Portable, rapid, highly specific, highly sensitive, can be used by Lay‐people and new assays can

be created in as little as 5 days.• NESDEP® IU includes built‐in instructions and software prompts that permits effective use by nearly everyone. No

special training is needed. In addition, NESDEP® IU can be used in virtually any indoor or outdoor location, either with an AC power supply, a DC service outlet, or on battery power.

• The device operates on a biochip that measures 7 millimeters (mm) by 14 mm and comprises nano‐scale electrodes and microfluidic structures that contain a mix of carbon nanotubes characterized to hybridize with very specific DNA molecules

• NESDEP® IU is based on patented technology that permits the detection of pathogens in less than two hours, from introduction of a raw sample to the full completion of the assay. This is made possible through the use of an advanced sample preparation process that separates DNA from cellular material and the application of AC Dielectrophoresis to directly identify target DNA, with the ability to identify as few one cell in a sample with two base‐pair discrimination.

• This technology eliminates delays in making decisions that impact the health and safety of consumers of food products, improves the safety of recreational and drinking water, and promises to enhance the ability of clinicians to treat patients once clearance is granted by the US Food and Drug Administration.

• This unmatched accuracy and precision is possible without the use of expensive laboratory equipment. NESDEP® IU can be used any lay person and does not require specialized training or experience.

21.6x35.5x111.7cm25kg

Portable

115‐220V AC / 12 V DC adaptor / Lithium Ion Battery Pack

75


ThroughputOne complete test, including sample prep and assay in 60 minutes.


Cost per run Approx. $25.00‐50.00 depending on target


Battery/ Auxiliary Power115‐220V AC / 12 V DC adaptor / Lithium Ion Battery Pack – 12 tests per charge.

EnvironmentalNo restrictions, testing has been performed.Refrigeration recommended for biochip kits.

MaintenanceAutomatically performs daily maintenance. F Cubed maintenance required every 6 months.


Lifespan10 years, 200,000 cycles

Operational Timing<5 minutes to set up, 7 step design for untrained person. 60 minutes to result.

Decontamination/CleaningNone required.

Other Equipment requiredEach test requires separate Biochip Kit.No other equipment or supplies.

Training/Ease of UseEasy to use – no training required.

Results ReportingPositive/Negative results, data result can be transmitted to designated location.

Sensitivity/Specificity/Detection RangeDSe: 93% DSp: 91% Error Margin 1.5% Detection range: Picomolar or one (1) bacteria in a 150mL sample.

Regulatory Approval/PatentUndergoing clinical trialsPatent – Yes




Partnerships: Development of new DNA or RNA assays.

Demonstration Video available at:

http://www.fcubed.biz/#video

NESDEP® F Cubed, LLC

76

LIAISON® DiaSorin Inc.

DiaSorin Inc.1951 Northwestern AvenueStillwater, MN, USA, 55082‐02851‐800‐328‐1482www.diasorin.com Lance Pearson

[email protected]

DETECTION:Antigen/Antibody using immunoassay testing ‐ “Flash” chemiluminescence technology (CLIA) with a paramagnetic microparticle solid phase (MP).

CLOSED SYSTEM

SINGLE ASSAY

SAMPLES:Blood, plasmaRefrigerated samples, can be frozen/thawed


DESCRIPTION:• Very robust and cost effective immunoassay platform.• Over 5000 devices installed worldwide.• The LIAISON® analyzer combines a flexible operating module with a broad menu of assays and leads to

high efficiency due to its long walk‐away time.• The possibility to run up to 15 different assays at a time provides rational everyday testing even with a

small number of samples.• The LIAISON® Analyzer is easy to use due to its touch‐screen monitor, clear software structure and

reagent Integral which contains all assay‐specific reagents.• Designed for immunoassay testing, LIAISON® Analyzer adopts a “Flash” chemiluminescence technology

(CLIA) with a paramagnetic microparticle solid phase (MP).• Efficient from the start, the LIAISON® Analyzer allows the continuous loading of samples, reagents and

the workload may be processed in random access or batch mode.• All assay methods are based on an internal Master Curve with 2‐point calibration.• Autodilution, rerun and reflex testing are performed by operator request and automatically performed by

the system. The LIAISON® system also has a STAT function in order to improve the efficiency of the laboratory.

• DiaSorin offer a wide range of tests on the LIAISON® Analyzer.

90x90x152cm90kg

Not Portable

110V power, distilled water required.

No auxiliary power/battery option

77


ThroughputUp to 120 tests/hour30‐40 min, depending on assay

POC/PON sample collection/analysisNo

Cost per runTest dependent, range $2.00 to $15.00/test.

SignatureSounds able to muteThermal output N/A


EnvironmentalTypical Lab temp rangeIndoor use only

MaintenancePreventative maintenance performed every 6 months.


Lifespan10‐12years

Operational TimingSample tubes placed into rack, then into analyzer.No downtime, continuous running.


Other Equipment requiredYes, controls, system consumables, distilled water. Software included.Controls require refrigeration.

Training/Ease of UseEasy to use, 2‐3 days training included.

Results ReportingPositive/Negative and Quantitative resultsDisplayed on instrument or can be printed and/or downloaded.

Sensitivity/SpecificityTest dependent ‐ Not provided

Regulatory Approval/PatentFDA approved platform.

Patent ‐ Yes


New AssaysWilling to adopt

PartnershipsWill consider, review of prospectus required.


List of Approved Assays: http://www.diasorin.com/sites/default/files/allegati/brochure%20LIAISION_%20ok.pdf

78

LIAISON® XL DiaSorin Inc.

DiaSorin Inc.1951 Northwestern AvenueStillwater, MN, USA, 55082‐02851‐800‐328‐1482www.diasorin.com Lance Pearson

[email protected]

DETECTION:Antigen/Antibody using immunoassay testing ‐ “Flash” chemiluminescence technology (CLIA) with a paramagnetic microparticle solid phase (MP).

CLOSED SYSTEM

SINGLE ASSAY Random access or batch immunoassay system.25 assays on board

SAMPLES:Blood, plasmaRefrigerated samples, can be frozen/thawed.

Cost/unit: $110,000.00 (USD)

DESCRIPTION:• Very robust and cost effective immunoassay platform.• Over 5000 devices installed worldwide.• LIAISON® XL is a fully automated chemiluminescence analyzer, performing complete sample processing

(sample pre‐dilutions, sample and reagent dispensing, incubations, wash processes, etc.) as well as measurement and evaluation.

• Up to 180 tests/hour.

• The innovative features of the system allow LIAISON® XL to improve efficiency in the immunoassay laboratories.

Fully automated solution Quality of resultsFlexible configurationHigh efficiency

152x90x152cm135kg

Not Portable

110V power, distilled water required.

No auxiliary power/battery option

79


ThroughputUp to 180 tests/hour30‐40 min, depending on assay


Cost per runTest dependent, range $2.00 to $15.00/test

SignatureSounds able to muteThermal output N/A


EnvironmentalTypical Lab temp rangeIndoor use only

MaintenancePreventative maintenance performed every 6 months.


Lifespan10‐12years

Operational TimingSample tubes placed into rack, then into analyzer.No downtime, continuous running.


Other Equipment requiredYes, controls, system consumables, distilled water. Software included.Controls require refrigeration.

Training/Ease of UseEasy to use, 2‐3 days training included.

Results ReportingPositive/Negative and Quantitative resultsDisplayed on instrument or can be printed and/or downloaded

Sensitivity/SpecificityTest dependent ‐ Not provided

Regulatory Approval/PatentFDA approved platform

Patent ‐ Yes



PartnershipsWill consider, review of prospectus required.


List of Approved Assays: http://www.diasorin.com/sites/default/files/allegati/brochure%20LIAISION_%20ok.pdf

80

m2000 Abbott Molecular

Abbott Molecular7115 Millcreek DriveMississauga, Ontario L5N 3R3780‐999‐0639

www.abbottmolecular.com/home.html Brad Thomas

[email protected]

DETECTION:Specific RNA and/or DNA sequences via genetic detection chemistry using flurorochrome labelled probes.

OPEN SYSTEM

MULTIPLEXEDUp to 5 biomarkers screened simultaneously in same well.

SAMPLES:All body tissues or samples (liquid or swabs)200‐1000µl Purification – None requiredPre‐processing – assay dependent

FULLY AUTOMATED

Cost/unit: $175,000.00 (CAD)

DESCRIPTION:• Abbott Molecular's m2000sp for sample preparation and the m2000rt for real‐time amplification and

detection are the cornerstones for this process.• Automated platform for batch analysis of nucleic acids. We are the market leader for precision and

accuracy.• Platform also allows users to produce their own assays in our open mode extractions and laboratory

designed tests.• The Abbott m2000 RealTime System provides automation from bar‐coded laboratory tube through

patient result, creating an efficient workflow for your laboratory. This automation enables laboratoriansto interface where their skills best contribute to results while minimizing errors and contamination.

• Abbott Molecular is committed to molecular diagnostics. Whether through new system software releases, innovative assay design or a constantly expanding mSystem menu, we are continuously evolving.

• Barcoded Laboratory Tubes• Reduces transcription error and provides positive sample ID.

• Precision Pipetting• Eliminates manual mixing or manipulation.

• Open Mode• Flexible protocol for various sample types and volumes.

• Efficient Sample Extraction• Flexible throughput options of 24 to 96 samples.

221x81x145cm211kg

Not Portable

110V power, 15amp, water and gas not required.

81


Throughput96 tests per run. Time is assay dependent.


Cost per runTest dependent

SignatureSounds able to muteScreen able to dimThermal output: 4100 BTU/hr, 1200WA

Battery/ Auxiliary PowerUninterrupted power supply provided that will last 15 minutes, battery could be used.

Environmental15°C to 30°C @ 30‐80% humidityElevation max 3000mIndoors, not in direct sunlight.Reagents and consumables stable at room temp.

MaintenanceStandard operating procedure in place for daily maintenance (10‐15 min), and more extensive weekly maintenance (1hr). Computer must be cycled once per month.

Warranty1 year warranty, lifetime warranty if under Reagent Acquisition program.

Lifespan>10 years.

Operational Timing20 minutes to load samples into machine. 5 minutes to clear deck after testing.

Decontamination/CleaningNo need to clean between runs, only daily maintenance.

Other Equipment requiredAll equipment and software provided

Training/Ease of UseSomewhat easy to use, training provided.

Results ReportingPositive/Negative and Quantitative resultsPrinted or transmitted to an LIS or exported to CD.

Sensitivity/SpecificityAssay Specific, Hepatitis B viral load assay we can detect down to 10 IU/mL and up to 1,000,000,000 IU/mL with 95% confidence.

Regulatory Approval/PatentHealth Canada approved platform and assays HCV, HIV‐1, HBV, HCV genotype, CMV, CTNG, High Risk HPV

Patent ‐ Yes



PartnershipsRegularly participate with diagnostic labs around the world on custom QRT/real time PCR solutions for our clients.

Peer reviewed citations: Numerous

m2000 Abbott Molecular

82


Notes


Appendix

Survey Sent to Vendors

Diagnostic Platform Vendor Survey

Defense Research and Development Canada (DRDC) is investigating currently available and emerging

diagnostic platforms for the detection of host‐specific biomarkers from clinical samples. Contractor

April Ingram ([email protected]) is conducting a comprehensive survey of these molecular

diagnostic platforms and potential partnership development and invites your participation by

completing the following questionnaire.

General Vendor Contact Information

Company/Developer Name: _______________ Diagnostic Platform Model#: ______________________

Address: _________________________________ Contact Person: __________________

_________________________________ Email Address: ___________________

_________________________________

Phone: _______________________________________ Cost per unit: _____________________

Web address: __________________________________

Molecular Diagnostic Platform Details

What type of biomarker does your platform detect? (e.g. protein, metabolite, specific RNA

sequence) More than one?

What type of biomarker detection chemistry is used on your platform? (e.g. immunological,

genetic)

Is your diagnostic platform a closed or open system?

Closed Open

Are the assays used in your platform single or multiplexed?

Single Multiplexed If Multiplexed, how many biomarkers are screened simultaneously? _____________


Please describe the clinical sample required.

Type (e.g. blood, saliva, urine) ____________________________________

Volume/Sample Consumption ____________________________________

Purity requirements ____________________________________________

Pre‐processing requirements _____________________________________

Please describe the sample throughput (e.g. number of tests per run)

______________________________________________________________________________

Level of automation

Fully Automated Semi‐Automated

What is the time required from sampling to result? Include separate time value for sample pre‐

processing, if required.

_____________________________________________________________________________________

Can the biological sample can be collected and analyzed at the point of care/need (POC/PON)?

Yes No

What is the estimated cost per test or run?

_____________________________________________________________________________________

Platform/Instrument Parameters

Diagnostic platform dimensions (include units of measure):

Height: _____________ Width: _______________ Length: ______________

Weight: _______________

Is your platform intended to be portable?

Yes No

Describe the utility requirements (power 110V/220V/water/gas) for your diagnostic platform.

_____________________________________________________________________________________

Describe the signature of your platform. Ability to minimize for covert application.

Sounds/Alarms ability to mute

Screen light ability to dim

Thermal output (BTUs/hour)________________

Can the platform be used on auxiliary power or battery? Please describe and indicate length of

time (e.g. single battery charge, number of tests performed per charge)

Yes No

If Yes, please describe

________________________________


Are there any known restrictions to the operating environment of your diagnostic platform?

(e.g. temperature, humidity, wind)

Yes No

If No, has testing in variable environments been conducted?

_______________________________

_______________________________

_______________________________

If Yes, please describe restrictions, (e.g. temperature range)

________________________________

________________________________

Describe the recommended maintenance schedule (e.g. months, number of tests) and required

maintenance tasks of your diagnostic platform?

_____________________________________________________________________________________

_____________________________________________________________________________________

Is there a warranty available for your diagnostic platform? If Yes, please describe.

_____________________________________________________________________________________

What is the estimated lifespan of your platform? (years/# of

tests)___________________________________________

Operational Information

Describe the sample processing/pre‐processing required, prior to loading onto platform for

testing.

_____________________________________________________________________________________

What is the estimated time required to set up your diagnostic platform for testing? Number of

steps?

______________________________________________________________________________

During system operation, what is the down time (clear and reboot time) between the end of an

analytical run and the beginning of the next analytical run?

_____________________________________________________________________________________

What are the cleaning or decontamination steps and estimated time needed to perform these steps

between tests?

_____________________________________________________________________________________


Are there other additional equipment or supplies required to perform testing? (e.g. software,

external vacuum, lab supplies/consumables)

Yes No If Yes, please list

_________________________________________

_________________________________________

If consumables are required for testing, please describe the handling/storage requirements.

(e.g temperature range, frozen, ambient, humidity levels)

_____________________________________________________________________________________

_____________________________________________________________________________________

Do you consider your platform to be easy to use?

Yes Somewhat No

Will specific training or skill set be required to conduct testing?

Yes No If Yes, describe

__________________________________

__________________________________

Results/Validation

Format of result reporting

Positive/Negative Quantitative

Describe the format that results are provided/displayed/delivered. (e.g. encrypted data to

mobile device)

_____________________________________________________________________________________

Please provide diagnostic sensitivity (DSe) and specificity (DSp) estimates/ranges for assays or

error margin (e.g ± 2%) estimates for your diagnostic platform.

DSe _____________________ DSp _______________________ Error Margin ________

Describe the detection range and quantitative capacity of your diagnostic platform

_____________________________________________________________________________________

Regulatory Approval Status

Has this particular platform been approved or submitted for approval for diagnostic use by any

regulatory agencies? (e.g. United States Food and Drug Administration (FDA), Health Canada,

European Medicines Agency (EMA)

Yes No Submitted Date of submission: ___________


Has your company had any other diagnostic devices approved by any regulatory agency (FDA,

HC, EMA), or submitted for approval?

Yes No Submitted If Yes/Submitted please provide details (date/agency)

________________________

Have any clinical assays been approved by any regulatory agencies for use on your diagnostic

platform?

Yes No If Yes, what are the approved assays?

________________________________

Does your diagnostic platform hold a patent?

Yes No

Technology Readiness

Describe the Technical Readiness of your diagnostic platform

Developmental/Design Pre‐Clinical/In‐house Testing Investigational Clinical

Commercialized

Is your diagnostic platform available as a hand‐held device?

Yes No No, but it can it be modified to be a

hand‐held device

If needed, are you willing to adopt new diagnostic assays for the platform?

Yes No

Partnerships

Are you willing to partner in new assay development?

Yes No

Describe the type of partnerships you are willing to participate in:

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_______________________________________

Additional Information

Please list references from the peer‐reviewed literature or conference abstracts citing the use of your diagnostic platform.


Please describe the key advantages of your diagnostic platform over others and/or any additional comments.


Weighted Analysis of Survey Responses

Platform Size Dimensions <1000cm3 (size of a pop can) 100 1000 to 5000cm3 75 5001 to 10,000cm3 (2-slice toaster ~10,000) 50 10,001 to 30,000cm3 (carry-on luggage ~27,000)

25

>30,000cm3 0 Weight <1kg 100 1 to 5 kg 90 6 to 15 kg 75 16 to 25 kg 25 >25kg 0 Throughput How many minutes would it take to perform a detection assay from start to finish on that sample? <2 minutes 100 2 to 15 minutes 80 16 to 30 minutes 60 31 minutes to 1 hour 40 >1 hour to 8 hours 20 >8 hours 0 Description of the maximum number of detection assays or individual tests the system or device can analyze per run with a single operator. Multiple samples, multiple tests/ sample per run

100

Multiple samples, single tests/ sample per run 75 1 sample, >10 tests/ sample per run 50 1 sample, <10 tests/ sample per run 25 1 sample, single test/ sample per run 0 Automation Fully Automated 100 Semi-Automated 80 Signature Can all sounds, alert tones, or alarms that the detection device or system produces be deactivated? Yes 100 No 0 Can all lights and visualization screen be dimmed or turned off? Yes 100 No 0 What is the thermal output of the system in British Thermal Units (BTU)/hour? <200 BTU/hour 100 200 to 500 BTU/hour 50 >500 BTU/hour 0


Ease of Use / Training Is the platform considered “Easy to Use”? Easy to use 100 Somewhat easy to use 50 Describe the training necessary for operation of the platform. Very brief (minutes-hours) training and minimal technical skills

100

Half day of training and some technical skills required

70

Day of training and some technical skills required

40

Operational Timing What is the average time to set-up, perform instrument warm-up and begin operation? No set-up of the system is required 100 <5 minutes 75 5-10 minutes 50 10-20 minutes 25 >20 minutes 0 What is the average down time) between the end of a run and the beginning of the next run? No downtime 100 <1 minute 90 1-3 minutes 75 3-5 minutes 50 >5 minutes 0 What is the number of steps required to perform a single detection assay of one sample? 0-2 steps 100 3-5 steps 75 6-8 steps 50 9-12 steps 25 >12 steps 0 Operational Conditions What is operational (suggested) temperature range? <-21° C to >42° C (all temperatures) 100 -21° C to 42° C 75 0° C to 41° C 50 4° C to 37° C 25 25° C to 37° C 0 What is the consumables storage temperature range? All temperatures/No consumables 100 Room temperature 75 4° C 50 Frozen 25 <-20° C (Cryo) 0 What is operational (suggested) relative humidity range? performance is not influenced by humidity 100 20% to 80% humidity 75 Dry environment required / unknown 0 Can the sample be analyzed at point of care (POC)? Yes 100 No 50


Consumables What is the number of additional consumables required (tubes, pipettes)? (not reagents, buffers) None or 1 100 2 75 3 50 4 or more 0 What is the shelf life of consumables, reagents/test kits at optimal storage conditions? > 3 years 100 1 to 3 years 75 6 months to 1 year 30 1 to 6 months 15 < 1 month 0 Maintenance & Platform Lifespan How often is maintenance required/recommended? Never 100 Yearly 75 Every 6 months 50 More than every 6 months 0 Who can perform the required maintenance? Customer 100 Vendor 0 Is maintenance included or does a service agreement have to be purchased? Included 100 Included for 1 year 50 Service agreement required 0 What is the expected life-span of the platform? >10 years 100 5 to 10 years 75 3 to 5 years 50 1 to 3 years 25 System Requirements What are the Electrical requirements? Electricity not required 100 Battery only 75 110V required 50 220V required 30 >220V or multiple outlets or dedicated circuit 0 Can platform run on battery power? Yes 100 No 0 What is the battery life while in operation mode? >8 hours 100 4 to 8 hours 75 2 to 4 hours 50 1 to 2 hours 30 <1 hour 0 Are water or gas required? Not required 100 Water only 40 Gas only 30


Water and gas required 0 Regulatory Approval/Platform Readiness Has the platform received approval from a regulatory agency (FDA, HC, EMA)? Yes 100 Pending/Submitted 50 No 20 What is the Technical Readiness of the platform? Commercialized 100 Clinical 80 Investigational 50 Pre-Clinical/In-house testing 30 Developmental Design 20 Has the platform been featured in peer reviewed literature or academic conferences? Yes 100 No 0 Is it an open or closed platform? Open 100 Closed 0 Samples What volume of the sample required to run an individual test? < 10 µl 100 10 to 50 µl 80 50 to 100 µl 60 100 to 250 µl 30 >250 µl 10 Does not test liquid samples 0 What type of samples can the platform identify agents from? Score 50 for each listed Blood Nasopharyngeal swab Urine Cerebrospinal fluid Saliva Vaginal swab Stool Plasma/serum Tissue Wound fluid Does the platform identify any environmental agents? (water, food, air, soil) Yes 100 No 0


Vendors Invited to Participate in

Survey

Survey Submitted (n=26) Replied to Invitation but No Survey Submitted (n=7) Indicated Technology was Not Suitable (Size/Detection) (n=3) Indicated Technology was Too Early in Development (n=1) No Response to Invitation or follow up (n=178)

3M - Focus Diagnostics US

3M - Innovation Diagnostics Canada

Abaxis

Abbott Diagnostics

Adarza

Advanced Analytical Technologies

Advanced Cell Diagnostics

Aegis/Diagnovus

AG Plus Diagnostics/ BioTest Diagnostics Ltd AIT Molecular Diagnostics

Akonni Biosystems

Alderon Biosciences

Alere I - Initial contact response, no survey submitted or response to follow-up. Anitoa Systems Inc.

ANP Technologies

Apollo Dx

Applied BioCode

Applied Biosystems/Life Tech

AquaBioChip

Aquilla Diagnostics

Array Corp

Astra Diagnostics

Aviana

Avioq Inc

Axela

Baebies

Beckman Coulter

Becton Dickinson (BD)

Bio Sentinel

Biocartis

Biocept

BioChain

Bioforce Nanoscience

BioMark

Biomeme

BioMerieux (referred to BioFire/ClermarkBiometrica

Bioneer Inc

Bio-Rad Lab Inc.

Biotheranostics

Boditech

Boston University

Bruker Daltonik GmbH

CACI

Capsenze

Cellex

Cepheid (Canada InterMedico)

Chemlmage Corp

ChipCare

Co-diagnostics

Columbia University – Not in development process. Copan

Corgenix

Custom Array

Daktari Diagnostics

DiaCarta - Initial contact response, no survey submitted or response to follow-up. Diacurate

Diagenetix

Diagnostic Biosensors LLC

Diagnostics Epistem

Diasorin

Diasys

Diaxonhit

Dioxins/Xenobiotic Detection Systems Inc.

Dx Terity

DxNA

EKF Diagnostics

Electrozyme LLC

Eli Tech Group

Enigma Diagnostics

Epigenomics

Eragen

Euro Immun

European Mobile Laboratory Project

Evik

F Cubed


Find Diagnostics

Fluke Biomedical

Focus Diagnostics

Forte Bio

Fraunhofer

Fujirebio Diagnostics

Future Diagnostics

Galaxy Diagnostics

Gamidor/Cytocell

Genalyte

Gene Fluidics

Genepoc

GenMark Diagnostics

Grifols

Hain Life Sciences

Hardy Diagnostics

Hologic/GenProbe/Prodesse/Thirdwave

Holomic

HTG

Human Longevity

IBL International

ICEPlex - PrimeraDx

Icubate

Idaho Technology / Biofire

Illumina

Immucor

Immunetics

Immunovia

IMMY

Inbios

IN-Institute of Nanoscience and Nanotechnology, Lisbon, Portugal; Department of Bioengineering, Instituto Superior Técnico Instantlabs

Integrated Diagnostics

Intellegent MDx

Intuitive BioSciences

Ionian Technologies

Iquum / Roche

ISurTec

IVDiagnostics

Jie Chou Laboratory

Laboratorios Conda

LifeTech

Liofilchem Italy

LucigenDx

Luminex

Lumora Diagnostics

Magna BioSciences

Mars Discovery

Mbio Diagnostics

MD Lab

MDx health

MedMira

Mennsana Research

Meridian BioScience

Meso Scale Defense/Diagnostics - Initial contact response, no survey submitted or response to follow-up. Miacom Diagnostics

Microbiologics

Micronic Inc

Micronics Pan NAT

Mobidiag

Mobile Assay

Mount Sinai Services

MP Biomedical

Multiplicom

MycroLab

Nanobiosym Inc.

Nanologix Inc.

NanoMix

Nanosphere

Nesher Technologies

Net Bio

Neuromics

OJ-BIO

Opgen

OPKO

Orgentec

OrthoClinical

Owlstone/Lonestar – Initial contact response, no survey submitted or response to follow-up. Oxford Immunotech

Pacific BioSciences

Personalis

Pirbright Institute

Positive ID Corp.


Precision System Science USA

ProLab Diagnostics

Proteocyte

Provista – “We decided not to submit an application this time around.” QIAGEN

QLIDA Diagnostics / Netscientific

QTL BioSystems

Quanterix – Floor model unit, vendor did not think device would be appropriate for needs. QuantiScientifics

Quantum Dx – Did not wish to participate, concerned about release of information and “competitor espionage”. Quest Diagnostics

Quidel

Ramot

Randox

Rapid Diagnostek Inc

Research International

Resonant Sensors

Rheonix Inc

Roche Diagnostics

Sandia

Sandstone Diagnostics

Savyon Diagnostics

Seegene

Sekisui/Genzyme

Shanna Kelley Xagenic uToronto

Siemens

Sividon

Smiths Detection/Patlon – “Do not feel our device is appropriate for needs.” Somalogic Inc.

Spartan Biosciences Inc.

SpeeDx pty

SRI – Unable to participate/provide details, recently awarded $10 million contract to develop novel medicines and diagnostics that can be used to thwart bioterrorism threats or an infectious disease epidemic by the SPAWAR Systems Center as part of the Defense Advanced Research Projects Agency’s (DARPA). Stanford University, Drew Hall Lab

Stratagene/Agilent

Sunrise Labs

Superior NanoBioSystems

Surnetics – “We are developing a platform technology for diagnostic devices, but our focus is on managing all the liquid flows within the device from the sample input to the point of detection. We develop coatings that control liquid flows without requiring pumps, controllers, or other hardware. Our coatings can be used to manage sample and reagent liquid flows; we can control liquid velocity, stop/start, and acceleration/deceleration all by changing the coating within the device. We would be interested in any potential projects with DRDC.” T2 Biosystems

Tecan

Techlab

Tetra Core Inc

Theradiag

ThermoFisher Scientific

TIRF Technologies

Trinity Biotech

True Diagnostics

TwistDx

UCLA - [email protected]

University of California Berkeley

University of Maryland

Vela Diagnostics

Veredus Laboratories

Vircell

Wyss J Collins Harvard

Xen Biofluidix Inc


Bibliography

*See Platform Summaries for Select System Specific Citations.

1. Molecular diagnostics: a revolution in progress. Chiu RW, Lo YM, Wittwer CT. Clin Chem. 2015 Jan;61(1):1-3.

2. Comparative effectiveness research and demonstrating clinical utility for molecular diagnostic tests. Deverka PA, Haga SB. Clin Chem. 2015 Jan;61(1):142-4.

3. Molecular isothermal techniques for combating infectious diseases: towards low-cost point-of-care diagnostics. de Paz HD, Brotons P, Muñoz-Almagro C. Expert Rev Mol Diagn. 2014 Sep;14(7):827-43.

4. Toward integrated molecular diagnostic system (i MDx): principles and applications. Park SM, Sabour AF, Son JH, Lee SH, Lee LP. IEEE Trans Biomed Eng. 2014 May;61(5):1506-21.

5. Developing precision medicine in a global world. Rubin EH, Allen JD, Nowak JA, Bates SE. Clin Cancer Res. 2014 Mar 15;20(6):1419-27.

6. It's all about the test: the complexity of companion diagnostic co-development in personalized medicine. Bates SE. Clin Cancer Res. 2014 Mar 15;20(6):1418.

7. New technologies help labs tackle old diagnostic problems. Moore N, McGrath KC. MLO Med Lab Obs. 2014 Dec;46(12):14-5.

8. On to the next phase of molecular diagnostics-the ultimate laboratory test: in observance of the 20th anniversary of the annual meeting of the association for molecular pathology. Farkas DH. J Mol Diagn. 2014 Nov;16(6):599-600.

9. Emerging technologies for the clinical microbiology laboratory. Buchan BW, Ledeboer NA. Clin Microbiol Rev. 2014 Oct;27(4):783-822.

10. Point-of-care technologies for molecular diagnostics using a drop of blood. Song Y, Huang YY, Liu X, Zhang X, Ferrari M, Qin L. Trends Biotechnol. 2014 Mar;32(3):132-9.

11. A novel thermostable polymerase for RNA and DNA loop-mediated isothermal amplification (LAMP). Chander Y, Koelbl J, Puckett J, Moser MJ, Klingele AJ, Liles MR, Carrias A, Mead DA, Schoenfeld TW. Front Microbiol. 2014 Aug 1;5:395.

12. The crucial role of molecular diagnostics. Panning M, Huzly D, Hengel H, Kern WV, Dettenkofer M. Dtsch Arztebl Int. 2014 Jan 6;111(1-2):10.

13. Assessing and comparing the performance of molecular diagnostic tests. O'Leary TJ. J Mol Diagn. 2014 Jan;16(1):1-2.

14. Molecular approaches to infectious disease assays. Schacht O. MLO Med Lab Obs. 2014 Jan;46(1):18.

15. Diagnostic molecular microbiology: a 2013 snapshot. Fairfax MR, Salimnia H. Clin Lab Med. 2013 Dec;33(4):787-803.

16. Replacement of biologic by molecular techniques in diagnostic virology: thirty years after the advent of PCR technology-do we still need conventional methods? Doerr HW. Med Microbiol Immunol. 2013 Dec;202(6):391-2.


17. Portable nucleic acid thermocyclers. Almassian DR, Cockrell LM, Nelson WM. Chem Soc Rev. 2013 Nov 21;42(22):8769-98.

18. Forces driving change in medical diagnostics. Panagiotou N. Clin Chim Acta. 2013 Jan 16;415:31-4.

19. Point-of-care nucleic acid detection using nanotechnology. Hartman MR, Ruiz RC, Hamada S, Xu C, Yancey KG, Yu Y, Han W, Luo D. Nanoscale. 2013 Nov 7;5(21):10141-54.

20. A novel method for sample delivery and testing of whole blood: gel strip PCR for point of care (POC) molecular diagnostics. Manage DP, Lauzon J, Atrazhev A, Pang X, Pilarski LM. Lab Chip. 2013 Oct 21;13(20):4011-4. PMID:

21. A Portable, Pressure Driven, Room Temperature Nucleic Acid Extraction and Storage System for Point of Care Molecular Diagnostics. Byrnes S, Fan A, Trueb J, Jareczek F, Mazzochette M, Sharon A, Sauer-Budge AF, Klapperich CM. Anal Methods. 2013 Jul 7;5(13):3177-3184.

22. Overcoming inhibition in real-time diagnostic PCR. Hedman J, Rådström P. Methods Mol Biol. 2013;943:17-48.

23. Short-term stability of pathogen-specific nucleic acid targets in clinical samples. Hasan MR, Tan R, Al-Rawahi GN, Thomas E, Tilley P. J Clin Microbiol. 2012 Dec;50(12):4147-50.

24. Multiplexed nucleic acid-based assays for molecular diagnostics of human disease. Deshpande A, White PS. Expert Rev Mol Diagn. 2012 Jul;12(6):645-59.

25. Quality control: more challenges for molecular diagnostics. Rundell C, Gordon J. MLO Med Lab Obs. 2012 May;44(5):56, 58, 60.

26. Molecular-based diagnostic testing developments. Allain G. MLO Med Lab Obs. 2012 Nov;44(11):48, 50.

27. Miniaturized technology for protein and nucleic acid point-of-care testing. Olasagasti F, Ruiz de Gordoa JC. Transl Res. 2012 Nov;160(5):332-45.

28. Highlights from the 7th European meeting on molecular diagnostics. Loonen AJ, Schuurman R, van den Brule AJ. Expert Rev Mol Diagn. 2012 Jan;12(1):17-9

29. Isothermal nucleic acid amplification technologies for point-of-care diagnostics: a critical review. Craw P, Balachandran W. Lab Chip. 2012 Jul 21;12(14):2469-86.

30. Point of care diagnostics: status and future. Gubala V, Harris LF, Ricco AJ, Tan MX, Williams DE. Anal Chem. 2012 Jan 17;84(2):487-515.

31. How novel molecular diagnostic technologies and biomarkers are revolutionizing genetic testing and patient care. Baudhuin LM, Donato LJ, Uphoff TS. Expert Rev Mol Diagn. 2012 Jan;12(1):25-37.

32. Instrument-free nucleic acid amplification assays for global health settings. LaBarre P, Boyle D, Hawkins K, Weigl B. Proc SPIE. 2011 May 16;8029.

33. Point-of-care nucleic acid testing for infectious diseases. Niemz A, Ferguson TM, Boyle DS. Trends Biotechnol. 2011 May;29(5):240-50.

34. A point-of-care instrument for rapid multiplexed pathogen genotyping. Myers FB, Henrikson RH, Xu L, Lee LP. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:3668-71.


35. Microvolume quantitation of nucleic acids. Desjardins PR, Conklin DS. Curr Protoc Mol Biol. 2011 Jan;Appendix 3:3J.

36. The application of multiplexed assay systems for molecular diagnostics. Schwarz E, VanBeveren NJ, Guest PC, Izmailov R, Bahn S. Int Rev Neurobiol. 2011;101:259-78.

37. POC tests: from antigen detection to molecular methods. Future trends. Ninove L, Nougairede A, Gazin C, Zandotti C, Drancourt M, de Lamballerie X, Charrel RN. J Clin Virol. 2010 Dec;49(4):304-5.

38. Applications of nucleic acids technologies in molecular diagnostics; multiplex assays in real time format. Simons G. Expert Rev Mol Diagn. 2010 Oct;10(7):853-5.

39. Diagnosing infections--current and anticipated technologies for point-of-care diagnostics and home-based testing. Bissonnette L, Bergeron MG. Clin Microbiol Infect. 2010 Aug;16(8):1044-53.

40. Miniaturization of molecular biological techniques for gene assay. Lien KY, Lee GB. Analyst. 2010 Jul;135(7):1499-518.

41. Recent advances in the development of nucleic acid diagnostics. O'Connor L, Glynn B. Expert Rev Med Devices. 2010 Jul;7(4):529-39.

42. Development of rapid, automated diagnostics for infectious disease: advances and challenges. Ince J, McNally A. Expert Rev Med Devices. 2009 Nov;6(6):641-51.

43. Point-of-care testing and molecular diagnostics: miniaturization required. Kiechle FL, Holland CA. Clin Lab Med. 2009 Sep;29(3):555-60.

44. Current applications and future trends of molecular diagnostics in clinical bacteriology. Weile J, Knabbe C. Anal Bioanal Chem. 2009 Jun;394(3):731-42.

45. Point-of-care molecular diagnostic systems--past, present and future. Holland CA, Kiechle FL. Curr Opin Microbiol. 2005 Oct;8(5):504-9.

Documents

Diagnostic Platform Survey / Review