This article has been updated to clarify the intended use of the assay.
By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – AutoGenomics today said that the US Food and Drug Administration has given 510(k) clearance for its Infiniti CYP2C19 assay.
The test detects three genetic variants, *2, *3, and *17 of the CYP450 2C19 gene. The test is for use on AutoGenomics' Infiniti Analyzer molecular diagnostic platform.
Though the label for the test does not specifically state that the assay will be used as an aid for Plavix (clopidogrel) dosing, it is expected to be used for that purpose.
In a statement, Fareed Kureshy, president and CEO of AutoGenomics, called the FDA decision "an important milestone in the era of personalized medicine," and added that several of the company's customers have been awaiting such regulatory clearance to implement testing in their practice.
Robert Cole, Chief Medical Officer for the Vista, Calif.-based firm, said that the test is unique in evaluating *17, "which can help clinicians identify ultra-metabolizers" of Plavix.
The Infiniti Analyzer, which was cleared by the FDA in 2007, has a menu of 42 applications, including 5 FDA-cleared products and 16 CE-marked products.
AutoGenomics is currently in waiting mode on its initial public offering, which was originally filed in 2008.