AutoGenomics Gets FDA Clearance for CYP2C19 Test, But Cannot Mention Plavix PGx | GenomeWeb

By Turna Ray

Although AutoGenomics has garnered clearance from the US Food and Drug Administration for its Infinity CYP2C19 Assay — which gauges the *2, *3, and *17 SNPs in the gene — the test's label makes no mention of its use as a pharmacogenetic test to administer Plavix.

AutoGenomics announced this week that it received 510(k) clearance from the US Food and Drug Administration to market its Infiniti CYP2C19 Assay.

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