Diagnostic Testing & Technology Report

Less than a year after approving a change in the labeling of warfarin to provide information about how people with certain genetic variations may respond to the popular blood thinner, the United States Food and Drug Administration (FDA) has cleared for marketing a third genotyping test to detect the presence of variations in the CYP2C9 and VKORC1 genes. Information about CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients at greater risk for warfarin sensitivity. The FDA previously cleared similar tests manufactured by Nanosphere (Northbrook, Ill.) and AutoGenomics (Carlsbad, Calif.).