Luminex CYP2C19 Assay Cleared by FDA, CE Marked in Europe | GenomeWeb

NEW YORK (GenomeWeb News) – Luminex said after the close of the market on Monday that its xTAG CYP2C19 kit has been cleared for marketing by the US Food and Drug Administration and has received the CE Mark in Europe.

The test is intended to aid physicians in determining treatment plans based on genetic variants in the P450 2C19 gene. CYP2C19 is a gene that encodes a phase one drug metabolizing enzyme. The CYP2C19 enzyme is responsible for metabolizing a number of prodrugs and drugs for treating ailments such as ulcers, seizures, malaria, and anxiety, Luminex said.

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