2015, PREPARED BY KYLE SUNG

MOLECULAR DIAGNOSTICS MARKET ANALYSIS & PRODUCT OVERVIEW

CONTENTS

IntroductionMarket Analysis SolMag aNAPs Target Market Competitions

WHAT IS MOLECULAR DIAGNOSTICS?

Detecting diseases through molecular level, Nucleic Acids (DNA, RNA)

WHY MOLECULAR DIAGNOSTICS??

• Extremely Sensitive• Qualitative & Quantitative (qPCR)• IVD market trend, fastest growing category

HOW TO EXTRACT NUCLEIC ACIDS?

Manual Extractions Automated Extractions

90%

10%

ManualAutomation

MOLECULAR DIAGNOSTIC MARKET---A Rapid Growth Market of IVDRapidly Increasing of Molecular Market

Data source: DARK Daily Laboratory and Pathology News

Data source: Frost & Sullivan

• Economic downturn and saturation• Unstable reimbursement regulations• For developed countries

• Increasing infectious diseases• Rising incidences of cancer• Genetic disorders• Blood screening

Year 2013-2019: CAGR: 11.1%

MOLECULAR DIAGNOSTIC MARKET

16%

15%

5%64%

Fish

Real Time PCR

Microarray

PCR

• Dominant nature & acceptance of PCR & Real Time PCR over other technologies, representsalmost 80% of the molecular diagnostic market.

Nucleotide:ATP, CTP,TTP,GTP

PrimersTemplate DNA

The Polymerase Chain Reaction (PCR) is a technology in molecular biology used to amplify a single copy or a few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence.

POLYMERASE CHAIN REACTION (PCR)

PCR & REAL TIME PCR INSTRMENTS

The Infectious disease area represent 55% of the molecular diagnostics market

MDX INFECTIOUS DISEASE MARKET SHARE

Basic Factor of PCR & other Molecular Analysis: Extraction and Purification of

Nucleic Acids(DNA, RNA)

Manual Extractions Automated Extractions

INTRODUCINGSolMag aNAPs(Automated Nucleic Acid Purification System)

PRODUCT INTRODUCTION

Automated Nucleic Acid Isolation Systems

®

INTENDED USE OF SOLMAG®

Magnetic Bead Separation: Bench-top automated system for quick purification of nucleic acids from bio-

specimens using magnetic bead separation technology.

Liquid Handling System: Liquid handling automation, using pre-filled reagent cartridges

For research and in vitro diagnosis use

CORE TECHNOLOGIES

The Solis-Charger® Technology

The Solis-ChargerR Technology is a novel magnetic bead-based technology that provides a switchable surface charge dependent on the pH and salt concentration of the surrounding buffer to facilitate nucleic acid purification. In low pH conditions, the magnetic beads have a positive charge that binds the negatively charged nucleic acid backbone (see figure1 below). Proteins and other contaminants are not bound and are simply washed away in an aqueous wash buffer. To elute nucleic acids, the charge on the surface of the bead is neutralized by raising the pH to 8.0 using a low salt elution buffer (see figure below). Purified nucleic acid elutes instantly into this elution buffer, and is ready for use in downstream applications.

SOLMAG ®12 SPECIFICATION

Automated Nucleic Acid Purification System

SolMag®12: Compact Bench-top Instrument Process 1-12 samples simultaneously 7 inches touch screen Light: Total weight less than 42 Kg Fast: Up to 12 results in 35 minutes Precise liquid volume and temperature control Extremely easy to operate and maintain

SolMag®24:The SolMag®24 provides all the advantages of the SolMag®12, and increases the throughput to 24 samples per run

SOLMAG ®12 SPECIFICATIONS

Light as feather: SolMag®12 weights only

42kgw, which is 50% lighter in average than other similar throughputs liquid handling extractor in the market.

MagNaPure Compact: 60Kg

Qiagen EZ1 Advanced XL: 48Kg

MagCore HF16: 70Kg

SolMag®12Part No. SVP0101

Dimensions (W x D x H) 637mm x 462mm x 540mm

Weight 42kgw

Interface 7” LCD touch-screen

Processing time 20 – 45mins

Throughput 1-12 Samples per run

Temperature Uniformity ±0.5℃

Liquid Extraction Volume Error Less than 5％

Sample Volume 50ul – 3000ul

Elution Volume 30ul – 200ul

Power Input power :90 ~ 132V&180 ~ 264Vby switch50/60HzOut power :5V60A

Certification CE、IVD、FDA

UNIQUE SPECIFICATIONS

7” Touch Screen: Optimized built-in protocol covers six major applications such as clinical

diagnostic, forensic science, food safety and CFC.

Built-in Template: Up to three preferable

templates can be set up by the users for performing the same routine protocol daily, which can also reduce the risk from human operational error.

SOLMAG ISOLATION KITS

Ready-to-use pre-filled, Reagent Cartridge: The SolMag® Nucleic Acid Isolation kits contain all reagents and

disposables needed for 48 nucleic acid isolation reactions.

SolMag® NA Isolation Kits

1. Blood/Tissue Nucleic Acid Isolation Kit

2. Virus Nucleic Acid Isolation Kit

3. Pathogen Nucleic Acid Isolation Kit

4. Food Safety Nucleic Acid Isolation Kit

5. Forensic Science DNA Isolation Kit

6. Circulation Nucleic Acid Isolation Kit

7. Virus Nucleic Acid Isolation Kit - Large Volume

• Use of prefilled, film-sealed reagent cartridges

• No manual adding chemicals or reagent buffers required

• Auto piercing after the purification protocol runs

INTEGRATED ADVANTAGES Reliable

Advanced magnetic separation technology High collection rate of Magnetic particles (≥98%) and sensitivity(≥98% of 100 copies/mL) High purity Consistent heating temperature: ≤1.5% well to well CV

Efficient Short set up time. extract 24 specimens within 30~40 minutes

User-friendly UV lamp, effective to avoid contamination Exceptionally stable & quiet during whole extraction process. Human-friendly touch screen user interface

TARGET MARKETS

•Pregnant women: NIFTY•Blood donators: Screening such as HBV, HCV

etc. from bloodScreening

•Cancer patients: Tumor target gene mutation detect for drug use

•Infectious disease patients: Drug resistance detection such as HBV YMDD mutation detect

Monitor

•Vaccine acceptors: Genotyping detection for virus before vaccine injection, such as HPV.

•Patients with chronic kidney disease or liver disease, HBV, HCV…: Blood test.

Prevention

•PCR for target gene accumulation•Sequencing for mutation & methylation

analysis•Further biological research such as

transcription, plasmid composing, RNAi etc.

Research

Hospital;Blood stations

Pharmacies; Dialysis center

Community Health Centers ;CDC

Biology Labs:AcademiesResearch Institutes

TARGET CUSTOMERSRegion:• Undeveloped, Under-Developed Countries: High infectious diseases rate (STD, HBV, HCV, HPV)

• Developed Countries: Gene Therapy, Sequencing (Micro Array, NGS)

Potential Customers:• Hospital & CDC

• Basic biological research

• Blood bank, DNA bank

• Forensic lab

• Food inspection lab

• GMO lab

COMPETITIONS- Magnetic Pillar/Rod System

Advantage Compact Size Relative low cost on instrument and kits

Disadvantage Easy to have magnetic bead residues in eluted products Limited or fixed sample/ elute volume handling choice No liquid handling system, extremely low flexibility for downstream automated integration. Semi-Automation: tedious manual set up procedure required, kills time and cause humor errors.

Ex:Maxwell (Promega) KingFisher (Thermo Fisher) Tan Beads (Taiwan) Vibrance (Acon, China) TianLong (China)

COMPETITIONS- Liquid Handling System

Advantage Fully walk away automation: Liquid Handling ensures the highest possible automated integration. (NA extraction PCR set up PCR detection, sample in to result out solution in future) Enable to handle a wide range of volumes on starting material. Extra manual steps during before or during extraction are not required.

Disadvantage Compare with Magnetic Pillar system, size of instrument is bigger and heavier. Higher instrument cost

Ex:MagNa Pure Compact (Roche) EZ1 Advanced (Qiagen) iPrep (Invitrogen)(All Manufactured by PSS, Japan) SOLMAG (SOLISON) MagCore (RBC)

COMPETITION COMPARISON

Instruments Solison(SolMag12)

Maxwell(Promega)

QiagenQia Symphony

MagNaPure(Compact)

Mechanical Design Liquid Handling MagneticPillar/Rod Working Station Liquid Handling

Open/Closed Platform Closed Open Closed Closed

Technology (magnetic and/orsilica/filtration (vacuum) extraction) Magnetic beads Magnetic beads Magnetic beads Magnetic beads

Input specimen volume range, min-max(ul) 50ul-3000ul 400ul 100-1000ul 200-400ul

Output volume, min-max(ul) 30-200ul N/A 20-150ul 60-200ul

Throughput 12 16 1-96 1-8

Estimated cost/ Instrument US$10,000 $17,000 US$50,000 US$30,000

Estimated cost/specimen $2.0 $5.5 $5.6 US$7

THANK YOU FOR YOUR ATTENTION!!

Solison Biotechnology Corp.Web: www.solisonbio.comAdd: No. 3-2, Chien-kuo road, TEPZ Tantzu, 427 Taichung, Taiwan R.O.CTel: +886 4 2531 1334 Fax: +886 2 2531 1343Mail: info@solisonbio.com