1. From ‘science in practise’ to
’science in business’
Jack A Schalken

2. AMBITION
M2M concentrates all expertise and facilities needed
for imaging (molecule-to-man) and translational
innovation (bench-to-bed)
A) Imaging from molecule-to-man B)Translational research – from bench-to-bed
small molecule virus ribosome animal cell drosophila mouse
Basic Pre-
science & Proof of Clinical
Globular protein bacterium plant cell mosquito homo clinical
sapiens discovery concept Trials
testing
10nm 100nm 10 μ 100 μ 1cm 1dm 1m
Individualized
Production
1 3 Small scale GMP- medicine &
Chemical evidence
production &
synthesis based practice
labeling
2 4
Imaging
Preclinical imaging Clinical imaging
(in vitro / in vivo) (volunteers, patients)
Molecular (Sub)cellular Organ & body
imaging imaging imaging

3. New biomarkers for prostate cancer are ‘ready
for prime time’
Biomarker Substrate Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6
GSTP1+ Urine/Bx yes yes ongoing ongoing yes no
methylation
PCA3DD3 Urine yes yes yes yes End 2006 2007/2008
PROGENSATM PROGENSATM
Gen-Probe Gen-Probe
CE-marked
T2-erg Urine yes yes yes ongoing yes no

4. Cells in
Prostatic urethra
DRE

7. ‘..Molecular Uroscopy..’
Progensa PCA3

8. 2003
•Unique biomarker and urine as
specimen (can be obtained non
invasively)

9. ‘Science in practise’ (1996-2003)
‘Science to business’ (2003-2006)
•Diagnocure (2000; PCA3 license from RUNMC)
•Genprobe (2003; sublicense PCA3 based
molecular diagnostics)
•2007; Progensa PCA3 launched

12. What now?
• PCA3 is a ‘specialty’ test
• Expertise
• Dedicated personel
• Facilities
• NL needs an Oncology Specialty Lab!!
• Solution: found one yourselves
• Opportunity meets ambition

13. ‘Times they are a changin’
Knowledge valorisation ‘95 & ‘06
• Ad hoc, often attenuating •Pro-active, enabling

14. Noviogendix
A spin off from the Radboud University Nijmegen Medical Center

15. Noviogendix
• Founded November 2006 by two RUNMC scientists
and a business developer
• First round financing Dec 2007 (Biogeneration
Ventures, PPM Oost)
• Clear terms between Radboud & Noviogendix
• Full transparency
• Clearly defined
• Negotiations took 6 months (much better than
average)

16. Molecular Diagnostics
‘core business’
•Specialty Oncology Laboratory
• Extensive panel for infectious diseases
• First on the EC market with PrCa marker,
-Progensa PCA3-
• Expanding prostate cancer test panel
• Expanding in other GU(genito-urinary)
diseases
•Research
• Marker IP portfolio GU
• Molecular profiling PrCa, RCC, TCC
• Target validation (well annotated
biorespositories)

17. Technology & fields of
expertise
• Core technology: molecular/gene based diagnostics
•Real time PCR (Roche)
•NASBA (Biomerieux)
•APTIMA DTS 400 (Genprobe)
• Disease focus
• Oncology
•GU(genito-urinary)
• Infectious diseases

18. Noviogendix y
• Good functioning management team (founders)
• Efficient and effective marketing and sales team (2)
• Key personel for research
• 10 people in total
• Milestones
• > 2000 tests sold
• New IPR
• Health kennis clusterregeling gemeente
Nijmegen
• Co-applicant for CTMM & PIDON

19. Noviogendix Oncology
Specialty Laboratory
• Netherlands
• UK
• Germany
• Belgium
• France
• Sweden
• Italy
• Misc. Overseas (incl south America and Australia)

20. Noviogendix Oncology
Specialty Laboratory

21. Noviogendix Research

22. •RU(NMC) together with Health valley and
the city of Nijmegen provide good soil for
biotechnological initiatives
•Growing entrepreneurial spirit at RUNMC
•Noviogendix can be ‘launched’ in 2009

23. Noviogendix Challenges
• Strengthen the management team
• Be prepared for a second round of financing
• Oncology Specialty Laboratory
• Move to new facility and get certification
• Develop strategy to increase sales
• Extend test portfolio
• Research
• Validation of markers
• Explore the licensing opportunities
(in- and out-)