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BiotechTracker - Personalized Medicine Advances  
June 27, 2003, Roche (Swiss: ROG) launched the Amplichip CYP450 test in the U.S. The DNA microarray-based unit identifies small sequence variations in CYP2D6 and CYP2C19 whose polymorphisms correlate with response to several types of drugs. 

Many commonly prescribed drugs, including treatments for depression, other common psychiatric disturbances, stomach and intestinal ulcers and related disorders, cardiovascular disease, high blood pressure, metabolic syndromes, and infectious diseases, are metabolized by the CP450 pathway. CYP2D6 and CYP2C19 encode proteins that are part of this pathway. Approximately 5% to 30% of members of specific ethnic groups highly represented in the U.S. population catabolize (metabolically break down) CP450-influenced drugs slowly, while 2% to >20% rapidly catabolize the drugs. Slow catabolizers are at risk for adversities related to high blood levels of drug. Rapid catabolizers are at risk for inadequate response given low blood levels of drug penetrating target tissues. Multiple permutations and outcomes exist for individuals taking multiple drugs metabolized by this pathway. 

Roche hopes that this microarray-based test, developed by Affymetrix (NASDAQ: AFFX), will lead to the development of individualized patient profiles that can diminish the approximately 100,000 annual U.S. deaths and 2 million concerning clinical events related to serious adverse drug reactions. European regulatory approval is expected “at the end of the year.” AmpliChip CYP450 will initially cost $350-400 per test, with Roche projecting $100 million in associated annual revenue by 2008. Roche plans to launch six clinically relevant microarray products by the end of 2004. 

The test heralds the accelerated use of pharmacogenetics, predictive medicine, and personalized medicine. Many pharmaceutical companies have shied away from technologies associated with these industries for fear of fostering markets characterized by a shrinking pool of a given drug’s recipients. Roche points out that pharmacogenetic testing will be driven in part by litigation fears. Active, resourceful patients are unlikely to tolerate avoidable adversities when reasonable tests help anticipate management of relevant clinical scenarios. Amplichip CYP450 is a beginning. 
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