www.fdanews.com/articles/67490-fda-clears-roche-s-amplichip-cyp450-diagnostic-test
FDA CLEARS ROCHE'S AMPLICHIP CYP450 DIAGNOSTIC TEST
January 12, 2005
The FDA has cleared Roche's AmpliChip CYP450 test for diagnostic use in the U.S., the company announced.
The product is a microarray-based diagnostic test that can influence drug efficacy and adverse drug reactions, the company said. It analyzes a patient's Cytochrome P450 2D6 and 2C19 genotypes from genomic DNA extracted from a blood sample.
Test results will allow physicians to consider unique genetic information from patients in selecting medications and doses of medications for a wide variety of common conditions such as cardiac diseases, pain and cancer.