Luminex Corporation (NASDAQ: LMNX), an Austin-based company advancing its pharmacogenetic initiative for improved patient care, announced that a new version of the xTAG CYP2D6 Kit has received FDA and European clearance. The company has also submitted xTAG CYP2C19 Kit for FDA for review.
“Test results that inform a physician on how a patient may react to a particular therapeutic are vital to improving patient care,” said Patrick J. Balthrop, president and chief executive officer of Luminex. “Pharmacogenetics is a fast-growing field and our flexible technology provides laboratories unique options to address their needs. Attaining FDA and CE clearance for xTAG CYP2D6 Kit demonstrates Luminex’s commitment to offering diagnostics that optimize patient outcomes and lower overall health-care costs.”
Cytochrome P450 2D6 (CYP2D6) is a clinically important gene coding, phase one drug metabolizing enzyme. CYP2D6 metabolizes greater than 25% of the drugs in use today, such as cardiovascular drugs, anti-psychotics, anti-depressants, pain-medications, pain-blockers, anti-emetics, anti-arrhythmic and anti-cancer drugs. Variations in the CYP2D6 gene can result in distinct drug metabolizing phenotypes, leading to drug toxicity, adverse drug reactions (ADRs), or an inadequate therapeutic effect.
The xTAG CYP2D6 Kit is an In Vitro Diagnostics (IVD) assay to analyze a patient’s CYP2D6 genotype from a DNA sample extracted from a blood sample. The test result can be great help for physicians in determining therapeutic strategy with drugs that will be metabolized by the cytochrome P450 2D6 gene product. The assay is run on the flexible Luminex(R) 100/200(TM) instrument. This new version of the kit optimizes performance on the *17 allele, and features an updated software algorithm that detects all 17 genotypes that the assay is cleared for, including deletion and duplication genotypes.
Luminex has also submitted xTAG CYP2C19 Kit for FDA and CE-clearance. The CYP2C19, enzyme, which metabolizes a variety of prodrugs, is used to treat ulcers, seizures, malaria and anxiety. It is also partially responsible for metabolizing drugs such as beta-blockers and some antidepressants. Luminex will be featuring the new xTAG CYP2D6 Kit at the American Association of Clinical Chemistry (AACC) Annual Meeting & Clinical Lab. (July 30 — Aug, 1 in Houston, TX, Booth #4539.)