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Luminex Gets FDA OK for New Version of CYP2D6 Kit

NEW YORK (GenomeWeb News) – Luminex announced after the close of the market Monday that the US Food and Drug Administration has cleared for marketing a new version of its xTAG CYP2D6 kit.

The test identifies variations in the Cytochrome P450 2D6 gene, which can affect how a patient metabolizes certain drugs. According to Luminex, CYP2D6 metabolizes more than 25 percent of drugs on the market today, including cardiovascular drugs, anti-psychotics, anti-depressants, and pain medications, among others.

Luminex said the new version of the test, which also has received the CE Mark, optimizes the performance on the *17 allele and features an updated software algorithm that detects all 17 genotypes for which the assay is cleared.

In addition to clearance of the new CYP2D6 test, Luminex said that it has submitted to the FDA and European regulators applications for clearance of its xTAG CYP2C19 kit, another drug metabolism assay. The CYP2C19 enzyme is responsible for metabolizing a variety of prodrugs and drugs used to treat ulcers, seizures, malaria, and anxiety, and plays a role in metabolizing beta blockers and some antidepressants, said Luminex.