Genetics & Genomics

Status:

Published in Medical Letter on the CDC and FDA, September 9th, 2007

AutoGenomics, a leader in developing automated molecular testing solutions, announced that its CYP450 2C9-VKORC1 panel that it submitted to the FDA for 510(k) clearance late last year, has now been evaluated by the Harvard Medical School-Partners HealthCare Center for Genetics and Genomics (HPCGG).

Warfarin (also called Coumadin) is a drug prescribed to help prevent blood clots. With more than 2 million prescriptions per year, one of the side effects of the drug is an increased risk of bleeding. The FDA re-labeled yesterday the warfarin package insert recommending the testing of multiple genetic variants in two genes namely 2C9 and VKORC1 for safer drug dosing.

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Source: Medical Letter on the CDC and FDA (2007-09-09)

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