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Rapid DNA test for CYP2C19 variants receives FDA clearance

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Spartan Bioscience announced that it has received FDA clearance for a rapid genetic testing device that identifies variants in the CYP2C19 gene.

The Spartan RX CYP2C19 System provides genetic results from a cheek swab in less than 60 minutes, according to information from a company press release.

The device is indicated for use to help physicians determine the best therapeutic strategy for drugs that are metabolized by the CYP450 2C19 genetic pathway, as some patients carry CYP2C19 gene variants that hamper response to those drugs, the company stated in the press release.

Drugs metabolized by the CYP450 2C19 genetic pathway include the antiplatelet therapy clopidogrel (Plavix, Sanofi Aventis), the beta-blocker propranolol, the antidepressant citalopram (Celexa, Forest), the proton pump inhibitor omeprazole and the anti-epileptic phenytoin.