Molecular Diagnostics: guided by the light

Jacqueline Vet 24 mei 2012

Activities:

• design and development of prototype molecular diagnostic assays

• workshops/ courses

Business model: contract research

ZZP-organisation

2007

ORGANISATION ZZP

NYtor Universitair Bedrijvencentrum

Toernooiveld 102

Nijmegen

HAN BioCentre

1. Collaboration agreement

2. Use labspace

3. NYtor hires research analist

4. Use both networks for new customers

Molecular Beacon Lab (USA) PHRI, UMDNJ, Dept. of Molecular Genetics

1. Assay design

2. New technological developments

3. Collaboration projects

Bio-Rad 1. Apparatus

2. Reagents

3. Network

Biolegio 1. primers-probe

synthesis

www.hanbiocentre.nl

www.molecular-beacons.org

Business model: designed assays are licensed to suitable party : fee +royalties

Activities: own product development

2012 BV

SERVICES

DEVELOPMENT

ORGANISATION BV

NYtor office Universitair Bedrijvencentrum

Toernooiveld 102

Nijmegen

Molecular Beacon Lab (USA) PHRI, UMDNJ, Dept. of Molecular Genetics

1. Assay design

2. New technological developments

3. Collaboration projects

Bio-Rad 1. Apparatus

2. Reagents

3. Network

Biolegio 1. primers-probe

synthesis

www.molecular-beacons.org

NYtor laboratory Mercator III

Toernooiveld 1

Nijmegen

NYtor TECHNOLOGY

Molecular beacon qPCR-technology

=

DNA-amplification + high specific DNA-detection (target) (molecular beacon)

NYtor TECHNOLOGY

24-05-2012

NYtor TECHNOLOGY - II

24-05-2012

Multiplex Four Target PCR Assay

NYtor TECHNOLOGY - III

Licensees: > 50 e.g.: bioMerieux, Becton Dickinson, Gen-Probe, Abbott Laboratories,

Bio-Rad, Affymetrix, Stratagene, Cepheid

24-05-2012

Technique developed at Public Health Research Institute (NY, VS)

1995-1998, postdoctoral fellowship: co-inventor / co-patent holder

Applications

Fields of use for the molecular beacons technology

1. Human in vitro diagnostics

a. Testing for infectious agents

b. Genetic testing

c. Oncology

2. Research

3. GMO testing

4. Food testing

5. Veterinary diagnostics

6. Hybrid seed production

7. Agricultural infectious agents

8. Forensics

9. Paternity testing

10. High-density probe arrays

11. Industrial microbiology

12. Blood products quality control

13. Environmental pathogens

Overview developed qPCR assays - I

FOOD/WATER:

•Legionella pneumophila

•Legionella species

•Campylobacter jejuni-coli-lari multiplex

•E.coli 0157

•Listeria monocytogenes

•Listeria species

PHARMACEUTICAL: •CHO qPCR: quantitation of host-cell residual DNA from Chinese Hamster Ovary (CHO) cells

VETERINARY:

•Scrapie genotyping: multiplex detection 5 SNPs (sheep)

•Helicobacter ganmani-rodentium multiplex (fish)

24-05-2012

Overview developed qPCR assays - II

CLINICAL:

•HIV-1, HIV-2, HTLV-II and HTLV-II multiplex

•Chlamydia pneumonia and Mycoplasma pneumonia multiplex

•Clostridium difficile ribotypes 017 and 027 multiplex

•Methylenetetrahydrofolate reductase (MTHFR)-gene (cardiovascular disease)

MISCELLANEOUS

•RT-qPCR assay to dermine optimum moment of harvesting (pears)

•Lactococcus lactis spp. lactis, spp. cremoris, spp. lactis biovar diacetylactis and

,Leuconostoc monoplex (starter cultures yogurt and cheese)

24-05-2012

24-05-2012

PROJECTS BV

1. Superbug project (EFRO) - Check-Points

2. Veterinary diagnostics - Biochek

3. Personalized Medicine - Future Diagnostics

24-05-2012

- Fast increase multi resistant bacteria (superbugs)

- Cause resistance: enzymes destroy antibiotics

• Extended Spectrum Beta-Lactamases (ESBL)

• Klebsiella Pneumonia Carbapenemase (KPC)

• New Delhi Metallo-Beta-Lactamase (NDM-1)

2005 2008 2002 Bron: http://ecdc.europa.eu/en/activities/surveillance/EARS-Net/Pages/Database.aspx

- ESBLs in Klebsiella pneumoniae

SUPERBUG PROJECT

Crucial: identification of bacteria at early stage

• optimal treatment of patient

• timely detection outbreaks prevent spread

24-05-2012

PRODUCT DEVELOPMENT

SuperBug assay

Rapid test for detection of

multi resistant bacteria

DNA

EXTRACTIE

1 uur

PROBE-LIGATIE

INCUBATIE

3,5 uur

MICROARRAY

INCUBATIE & ANALYSE

2,5 uur

DNA

EXTRACTIE

1 uur

qPCR

met MB

1 uur

Tijd (uren)

2 0 7

SuperBug

assay

conventionele

test

Essential time saving ! (5 hour reduction to detection)

24-05-2011

SAMENWERKINGSPARTNER

Bedrijfsstrategie NYtor: ontwikkelde testen worden ter licentie aangeboden

aan een geschikte marktpartij met bijbehorende royaltyregeling.

Voor de SuperBug assay samenwerking met:

Check-Points BV (Wageningen)

• wereldwijde marktleider op gebied van analyse van

gramnegatieve bacteriën.

• internationaal distributienetwerk in 30 landen

NYtor + Check-Points: sterk team snelle en efficiënte onwikkeling van

de superbug assay

24-05-2011

SUPERBUG – INVESTMENT/EARNINGS

SuperBug assay – 10 year prognosis

-200

-100

0

100

200

300

400

500

600

700

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

REALISTIC

WORST CASE

OPTIMISTIC

%

EFRO grant 50

Upfront Fee 25

NYtor/KERN 25

Total 100

‘PERSONALIZED MEDICINE’-ASSAYS

• Strategic collaboration with Future Diagnostics

NYtor: prototype assay development

Future diagnostics: validation of the prototype assays

• accurate diagnostic tests that identify patients who can benefit from

targeted therapies

• Lab-on-a-Chip: coupling self-reporting molecular beacons to micro array format

• Sloppy molecular beacons: increase multiplex format of qPCR up to hunderd targets

FUTURE PERSPECTIVES

FUTURE CHALLENGES

• new facilities

• NYtor team: find right people

• financing

• business strategy