Luminex Gets FDA, European Clearance For New Version Of XTAG CYP2D6 Kit

(RTTNews) - Luminex Corporation (LMNX) Monday said it received U.S. FDA and European clearance for a new version of xTAG CYP2D6 Kit. Additionally the company has submitted xTAG 2C19 Kit to FDA for review.

Patrick Balthrop, president and chief executive officer of Luminex, said "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 that encodes a phase one drug metabolizing enzyme. CYP2D6 metabolizes greater than 25% of the drugs in use today including cardiovascular drugs, anti-psychotics, anti-depressants, pain-medications, ß-blockers, anti-emetics, antiarrhythmics and anti-cancer drugs. Variations in the CYP2D6 gene can result in distinct drug metabolizing phenotypes leading to sub-optimal drug responses, such as drug toxicity, adverse drug reactions (ADRs), or inadequate therapeutic effect. An estimated 2.2 million serious ADRs occur yearly resulting in 100,000 deaths at a cost of $136 billion in the United States alone.