Roche's AmpliChip CYP450 test cleared by US FDA

Swiss drug major Roche's first microarray-based test, the AmpliChip CYP450 Test, has been cleared by the US Food and Drug Administration for diagnostic use.

The test, which combines Roche's patented polymerase chain reaction amplification technology with Affymetrix microarray technology, analyzes a patient's Cytochrome P450 2D6 and 2C19 genotypes from genomic DNA extracted from a blood sample. The results will allow physicians to consider unique genetic information from patients in selecting medications and doses for many common conditions such as cardiac diseases, pain and cancer, help prevent harmful drug interactions and assure drugs are used optimally, says the firm.

"Major step forward in making personalized medicine a reality"