Diagnostic Kits/Diagnosis or drug- Will pharmaceutical companies or diagnostics manufacturers earn more from personalized medicine

Kling. Diagnosis or drug? Will pharmaceutical companies or diagnostics manufacturers earn more from personalized medicine? EMBO reports (2007) vol. 8 (10) pp. 903-6. Accessed December 14, 2009 at http://www.nature.com/embor/journal/v8/n10/full/7401080.html

• focuses on Genomic Health's Oncotype DX test (based on expression levels) - predicts recurrence of breast cancer
• also mentions Roche's AmpliChip (based on CYP2D6 and CYP2C19 genes) - predicts drug metabolism
• and XDx AlloMap (based on expression levels) - predicts heart transplant rejection
• and Applied Genomics MammoStrat test (based on antibodies) - predicts recurrence of a particular breast cancer
• 70% of clinical decisions made by physicians in US are based on diagnostics (not necessarily GDx), but only 2% of $2 trillion annually spent on healthcare goes into diagnostics
  • Clinically validating a test is probably "the biggest barrier to progress" says Doug Ross, Chief Scientific Officer of Applied Genomics.
  • Genomic Health's Oncotype DX test was clinically validated with samples from the National Surgical Adjuvant Breast and Bowel Foundation (NSABP).
    • "Genomic Health's competitive advantage in the marketplace is derived in large part from the strength of the data from their published NSABP results," says Ross.
  • so sharing of tissue samples for clinical trials to validate a GDx could be an important force encouraging collaboration.

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