Luminex Corp, Austin, Tex, has received FDA clearance for the xTAG® CYP2C19 Kit, a comprehensive genotyping assay.

Luminex largeThis new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.

“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,” says Patrick J. Balthrop, president and CEO.

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 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.

Genetic variations in the CYP2C19 gene can result in distinct drug metabolizing phenotypes leading to suboptimal drug responses, such as drug toxicity, adverse drug reactions (ADRs), or inadequate therapeutic effect.

The FDA Adverse Events Reporting system (FAERS) estimated nearly 800,000 ADRs in the United States and Europe combined for the year 2011.1 The incidence of serious and fatal ADRs has been rising with the increase in the number of medications prescribed. An estimated $3.5 billion is spent on additional medical cost associated with ADRs annually and at least 40% of ambulatory ADRs may be preventable.2

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 to aid clinicians in determining therapeutic strategy for therapeutics metabolized by the cytochrome P450 2C19 gene product. The assay is run on the Luminex® 100/200™ or MAGPIX® instruments.

[Source: Luminex Corp]


1. FAERS Domestic and Foreign Reports by Year. FDA. 2012 June 30; cited 2013 June 24.

2. Medication Safety Basics. CDC. Cited 2013 June 24.