AutoGenomics granted FDA 510(k) clearance for INFINITI CYP2C19 Assay

AutoGenomics, a leader in providing automated, molecular testing solutions announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its INFINITI® CYP2C19 Assay.  The test detects 3 genetic variants, *2, *3, *17, of the CYP450 2C19 gene and is to be used on the company's automated molecular testing platform, the INFINITI® Analyzer.  

"We are very excited to receive FDA clearance for our 2C19 test" said Fareed Kureshy, President and CEO of AutoGenomics. "The necessity of this genetic test has been implicated in literature now for several years.  The FDA has now provided clinicians with a tool in determining medical strategies for therapeutics that are metabolized by the CYP 450 2C19 gene test specifically * 2, *3, *17. This is an important milestone in the era of personalized medicine. Several of our customers are awaiting such clearance to implement testing in their practice." He further said, "we continue to expand our portfolio of FDA cleared products." "The INFINITI® CYP 450 2C19 test is unique in evaluating *17 which can help clinicians identify ultra metabolizers" said Robert Cole, MD., Chief Medical Officer at AutoGenomics

The INFINITI® System features a broad menu of 42 applications, with 5 FDA cleared products and 16 CE marked products.