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Dx Focus: Luminex Gets FDA OK, CE Mark for xTAG CYP2C19 Kit


Luminex said this week that it has received US Food and Drug Administration clearance for the xTAG CYP2C19 kit, a comprehensive genotyping assay intended to help physicians determine patient treatment plans based on certain genetic variants of the P450 2C19 gene. The kit also received CE marking, making it available commercially in Europe.

Luminex's assay analyzes a patient's CYP2C19 genotype from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The assay is run on the Luminex 100/200 or MagPix instruments.

CYP2C19 is a clinically important gene that encodes a phase-one drug-metabolizing enzyme that is responsible for metabolizing a variety of prodrugs and drugs used to treat a number of conditions such as ulcers, seizures, malaria, and anxiety. It is also important in metabolizing drugs such as beta-blockers, anti-clotting agents, and some antidepressants.

In July, Luminex received FDA clearance for a new version of the xTAG CYP2D6 kit, which analyzes a patient's CYP2D6 genotype in order to aid physicians in determining therapeutic strategy for drugs metabolized by the P450 2D6 gene product. That assay also runs on the Luminex 100/200 instrument (PCR Insider, 7/18/2013).