Harvard Partners successfully validate 2C9-VKORC1 panel
Carlsbad, CA, August 17, 2007, - AutoGenomics, a leader in developing automated molecular testing solutions, announced today 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.
“We have completed a successful evaluation of the INFINITI 2C9-VKORC1 panel which has the potential to optimize warfarin dosing and lower the risk of bleeding complications” said Dr. Raju Kucherlapati, Scientific Director of the Harvard Medical School-Partners HealthCare Center for Genetics and Genomics (HPCGG) in Cambridge, Massachusetts. HPCGG is coordinating the “CReating an Optimal Warfarin Nomogram” (CROWN) Trial which is a prospective dosing study utilizing genetic testing to determine the optimal warfarin dose and how this information can be used for clinical care.
“We are pleased to see that through the re-labeling of the warfarin package insert, the FDA has recognized that patients with certain genetic variants may benefit from lower initial dosage thus reducing the risk of major bleeding events” said Ram Vairavan, Senior Vice President at AutoGenomics. He further said “Our expanded panel of genetic variants mentioned in the package insert encompassing African, Asian and other ethnic groups enables same day dosing on our automated multiplexing platform.”
AutoGenomics Inc., a privately held company based in Carlsbad, CA, has developed the first automated, microarray based multiplexing diagnostic platforms that can be used to assess disease signatures with novel genomic and proteomic markers in the area of genetic disorders, infectious disease, cancer and pharmacogenetics. With the discovery of genes and their link to various disease states the platform has the versatility to revolutionize the way patients are diagnosed, monitored and managed leading to the era of personalized medicine. For more information, please visit www.autogenomics.com
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