Presentation at Japan Analytical Instruments Association conference, Chiba, 10/2008

1. Molecular Diagnostics and Personalized Medicine: Challenges and Opportunities David S. Lester, Ph.D. Executive VP, Corporate Development

2. Wikipedia Definition “ Personalized medicine is the concept that information about an patient's genotype or gene expression profile could be used to tailor medical care to an individual's needs. Such information could be used to help stratify disease status, select between different medications and/or tailor their dosage, provide a specific therapy for an individual's disease, or initiate a preventative measure that is particularly suited to that patient at the time of administration.” http://en.wikipedia.org/wiki/Personalized_medicine

3. The Two Components of Personalized Medicine Pharmaceuticals + Molecular Diagnostics = Personalized Medicine

5. The Discovery to Delivery Chain for Diagnostics; Gene Express, Inc. Discovery CLIA assay Standardization & Validation Commercialization Delivery/ Clinical Practice + $50B Market Academic Labs Technology Platforms (ABI, Beckmann, Ventana, Agilent, etc.) Monogram, Roche Genomic Health, Navigenics Roche, Abbott, Siemens, Philips, etc. LabCorp, Quest CROs SUPPLY DELIVERY

9. bcr-abl Molecular Assay Defined by initial creation of translocation between Chromosomes 9 and 22 BCR-ABL Fusion Gene is necessary and sufficient to cause CML Mughal and Goldman 2006 Deininger et al. Blood 96:3343 2000

11. Conclusions of AMP Survey to 39 laboratories “ Our study emphasizes the need for optimization of real time qRT-PCR before offering clinical testing and the need for widely available standards that can be used for calibration.” Zhang et al. J. Mol Diagn. 9:421,2007

13. Examples of challenges in the present system 2. The question of reimbursement

14. Examples of challenges in the present system 2. The question of reimbursement Adapted from presentation by Bruce Quinn Senior Health Policy Analyst, Foley Hoag LLP

15. The Realities of Reimbursement - Medicare

16. Examples of Cost of Development of an MDx

17. You get what you pay for!

18. Some suggested changes – must come through govt. reforms

19. Conclusions

20. Thank You! David Lester, Executive VP [email_address]