AutoGenomics Files Infiniti Warfarin-Metabolism Assay with FDA for 510(k) Clearance
Carlsbad, CA, December 11, 2006 - AutoGenomics, a leader in developing automated molecular testing solutions, announced today that it has submitted a 510k application to the FDA in October 2006 for its CYP450 2C9 / VKORC1 assay on its INFINITI™ System.
Warfarin is one of the most widely prescribed anticoagulants that prevents harmful clotting after a heart attack, stroke or major surgery. Numerous factors can impact a person’s metabolism of warfarin, including genetic variations within the enzyme CYP450 2C9 and Vitamin K Epoxide Reductase (VKORC1). AutoGenomics has completed a multicenter clinical study utilizing an expanded panel of genetic variants of CYP450 2C9 / VKORC1.
As one of the clinical evaluators of the INFINITI™ Platform, Dr. Brian F. Gage, Medical Director of the Barnes-Jewish Hospital Anticoagulation Service at Washington University in St. Louis said “By detecting variants of CYP450 2C9 and VKORC1, physicians will be able to initiate warfarin therapy tailored to their patients' genetic profile. Our hypothesis is that pharmacogenetics-based warfarin therapy will be safer than standard warfarin initiation."
Configured in a multiplexed format for simultaneous detection of all genetic variants, the INFINITI™ 2C9 / VKORC1 assay is designed to detect *2, *3, *4, *5, *6, *11 alleles of the CYP450 2C9 gene and 861, 3673, 5808, 6009, 6484, 6853, 7566, 8773 and 9041 of the VKORC1 gene.
“Use of AutoGenomics’ expanded screening panel of genetic variants for CYP450 2C9 and VKORC1 allows for improved characterization of patients from diverse ethnic backgrounds” said Dr. Michael Phillips, Director of the Genome Quebec and Montreal Heart Institute Pharmacogenomic Center in Montreal. He further stated that “The INFINITI™ System offered the most comprehensive testing panel that was easy to use and enabled rapid results within the same day to optimize warfarin dosing.”
AutoGenomics Inc., a privately held company based in Carlsbad, CA, has developed one of the first 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 contact www.autogenomics.com
For further information please contact:
Senior Vice President Sales & Marketing, AutoGenomics
760-804-7378 x 305