CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Luminex announced it has received FDA and European clearance for a comprehensive genotyping assay, xTAG CYP2C19 kit. This new test provides a personalized approach to determining patient treatment based on certain genetic variants of the P450 2C19 gene.
Cytochrome P450 2C19 (CYP2C19) is a clinically important gene that encodes a phase-one drug-metabolizing enzyme. The CYP2C19 enzyme is responsible for metabolizing a variety of prodrugs and drugs used to treat 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. Genetic variations in the CYP2C19 gene can result in distinct drug-metabolizing phenotypes, leading to drug toxicity, adverse drug reactions, or inadequate therapeutic effect.
Luminex’s xTAG CYP2C19 kit is an IVD assay that analyzes a patient’s CYP2C19 genotype from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. It aids clinicians in determining therapeutic strategy for drugs metabolized by the cytochrome P450 2C19 gene product. The assay is run on the Luminex 100/200 or MAGPIX instruments.
Luminex, 888-219-8020