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Luminex Corporation Launches New FDA Cleared Pharmacogenetic Diagnostic Test

Wed, 11/17/2010 - 7:34am
Bio-Medicine.Org

AUSTIN, Texas, Nov. 17, 2010 /PRNewswire-FirstCall/ -- Luminex Corporation (Nasdaq: LMNX), today announced that it has commercially launched its first pharmacogenetic test, the xTAG® CYP2D6 Kit, which recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The new test enables a personalized medicine approach to help physicians manage patients for whom they may prescribe certain drugs that are metabolized by the enzyme cytochrome P450 2D6.

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"The xTAG CYP2D6 Kit will be an important tool in the fast-growing field of personalized medicine," said Patrick J. Balthrop, president and CEO of Luminex. "The first innovation in CYP2D6 diagnostics in five years, it combines the power of multiplexing with the promise of pharmacogenetics. The information it provides has significant potential to help doctors improve care by assisting them in determining the best therapeutic strategy for an individual patient."

CYP2D6 is an enzyme that is involved in the metabolism of approximately one quarter of all prescription drugs, including betablockers, opiates, selective serotonin reuptake inhibitors (SSRIs), tricylic antidepressants (TCAs), neuroleptics and antiarrhythmics. People may carry a slow- or fast–acting form of the enzyme while others have a non-functional version of the CYP2D6 gene, or allele, which can affect how an individual's body responds to these therapies.

The xTAG CYP2D6 Kit helps identify individuals who possess both common and rare CYP2D6 poor-metabolizer variants. Abnormal metabolizers are more likely to experience adverse drug reaction

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