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Luminex obtains FDA and European clearance for genotyping assay

Luminex, a biotechnology company, has obtained the US Food and Drug Administration (FDA) and European approvals for a new personalized medicine genotyping assay, xTAG CYP2C19 kit.

xTAG CYP2C19 kit is a comprehensive genotyping assay that analyzes patient’s Cytochrome P450 2C19 (CYP2C19) genotype from genomic DNA to assist physicians in determining therapeutic strategy for therapeutics metabolized by Cytochrome P450 2C19 gene product.

The assay is run on the Luminex 100/200 or MAGPIX instruments.

Luminex president and CEO Patrick J Balthrop noted 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.

"Our growing portfolio of pharmacogenetic assays include both FDA cleared and CE marked xTAG CYP2D6 and CYP2C19 assays demonstrating our commitment to offer testing laboratories regulatory cleared assays that are safe and effective for use as an aid in patient management decisions," Balthrop added.

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