AutoGenomics Gets FDA Clearance for CYP2C19 Test, But Cannot Mention Plavix PGx

Although several studies have shown that carriers of CYP2C19 alleles do not respond to Plavix as well as non-carriers, and the FDA has updated the drug's label to notify physicians of the role of these alleles in Plavix metabolism, the assay's label specifically notes that "the INFINITI CYP2C19 Assay is not intended to be used to predict drug response or non-response."