NEW YORK (GenomeWeb News) – AutoGenomics said last week that the Harvard Medical School-Partners HealthCare Center for Genetics and Genomics has completed an evaluation of its CYP450 2C9-VKORC1 panel for warfarin dosing.
The company submitted the assay to the US Food and Drug Administration for 510(k) approval last December. The test runs on AutoGenomics’ Infiniti platform, which the FDA cleared for multiplex testing earlier this year.
The Infiniti 2C9-VKORC1 panel “has the potential to optimize warfarin dosing and lower the risk of bleeding complications," said Raju Kucherlapati, HPCGG scientific director, in a statement.
HPCGG is leading the "CReating an Optimal Warfarin Nomogram," or CROWN, trial, a prospective study that is using genetic tests to determine optimal warfarin dosing. The CROWN trial is scheduled to be completed by the end of the year. Further information on the study is available here.
Last week, the FDA updated warfarin’s label to include information on how variations in the CYP2C9 and VKORC1 genes may affect patient response to the anticoagulant.