AutoGenomics, an in-vitro diagnostic provider of automated, molecular testing solutions, has received the US Food and Drug Administration (FDA) 510(k) clearance 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.
The Infiniti system features a broad menu of 42 applications, with 5 FDA cleared products and 16 CE marked products.
AutoGenomics president and CEO Fareed Kureshy said that they are excited to receive FDA clearance for 2C19 test and the necessity of the genetic test has been implicated in literature for several years.
“The FDA has provided clinicians with a tool in determining medical strategies for therapeutics that are metabolised by the CYP 450 2C19 gene test specifically * 2, *3, *17,” Kureshy said.
AutoGenomics chief medical officer Robert Cole said that the Infiniti CYP 450 2C19 test is unique in evaluating *17 which can help clinicians identify ultra metabolisers and the Infiniti System features a broad menu of 42 applications, with 5 FDA cleared products and 16 CE marked products.