Diagnostics

AmpliChip CYP450 test receives U.S. FDA clearance

Published in Cancer Weekly, February 8th, 2005

Roche announced that its first microarray-based test, the AmpliChip CYP450 Test, has been cleared by the U.S. Food and Drug Administration (FDA) for diagnostic use in the United States.

This test, which is powered by Affymetrix microarray technology, analyses 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.

"We are extremely pleased that the AmpliChip CYP450 Test has gained FDA...

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Source: Cancer Weekly (2005-02-08)

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