FDA Clears AutoGenomics' CYP2C19 Assay | GenomeWeb

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.

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