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Oct 27, 2010

AutoGenomics Granted FDA Approval for Infiniti CYP2C19 Assay

AutoGenomics Granted FDA Approval for Infiniti CYP2C19 Assay

Test detects three genetic variants of CYP450 2C19 gene.[Stefan]

  • AutoGenomics  received 510(k) clearance from the FDA to market its Infiniti CYP2C19 Assay. The test is designed to detect three genetic variants of the CYP450 2C19 gene, specifically *2, *3, and *17. The assay is intended to be used on the company’s molecular testing platform the Infiniti Analyzer.

    The CYP450 2C19 gene encodes for cytochrome P450 2C19, a member of the CP450 mixed-function oxidase system. The enzyme is involved in the metabolism of xenobiotics in the body and of several important groups of drugs including certain proton pump inhibitors and antiepileptics.

    “The necessity of this genetic test has been implicated in literature now for several years,” says Fareed Kureshy, president and CEO of AutoGenomics  “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. ”

    Robert Cole, M.D., CMO at AutoGenomics, adds, “The Infinity CYP450 2C19 test is unique in evaluating *17, which can help clinicians identify ultrametabolizers.”

    The Infiniti Analyzer is an automated, multiplexing, continuous-flow, random-access microarray platform. It features a menu of 42 applications, with five FDA cleared products and 16 CE-marked products.

    The analyzer integrates various discrete test processes such as sample handling, reagent management, hybridization, stringency, and detection for the analyses of DNA into a self-contained system. It is used for clinical multiplex systems intended to measure and sort multiple signals from clinical samples.

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