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Luminex CYP2C19 Assay Cleared by FDA, CE Marked in Europe

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.

It added that the enzyme plays an important role in metabolizing drugs such as beta-blockers, anticlotting agents, and some antidepressants. Variations in the CYP2C19 gene can result in distinct drug metabolizing phenotypes, which in turn can result in less-than-optimal drug responses. Luminex's test is an in vitro diagnostic that analyzes a patient's CYP2C19 genotype from DNA extracted from ethylenediaminetetraacetic acid or citrate anticoagulated whole blood samples.

The assay runs on Luminex's 100/200 or MagPix instruments.

"Since cytochrome (CYP450) enzymes are responsible for metabolizing over half of all drugs on the market today, it is important for a physician to have valuable information to determine whether a patient's specific genotype may impact their drug response," Luminex President and CEO Patrick Balthrop said in a statement.

This latest FDA clearance follows a nod from the agency this past summer to market a new version of its xTAG CYP2D6 kit for identifying variations in the Cytochrome P450 2D6 gene.