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Luminex Corporation Launches New FDA Cleared Pharmacogenetic Diagnostic Test
Date:11/17/2010

s from medications acted upon by CYP2D6 and can be at increased risk of dangerous drug-induced side effects, drug interactions and therapeutic failure. These individuals may need to receive alternative treatment doses and undergo drug level monitoring.

"The clinical utility of CYP2D6 genotyping is very important and diverse, as the enzyme metabolizes nearly 25 percent of all medications used across a myriad of medical disciplines. Combined with 10 percent poor-metabolizer phenotype in the general population, it dictates a critical need for the availability of high quality CYP2D6 genotyping," said Kristen Reynolds, PhD, vice president of Laboratory Operations, PGXL Laboratories. "The xTAG CYP2D6 assay from Luminex provides our lab with a robust multiplex assay, which allows for higher throughput, shorter turnaround times, and less per-sample cost than previous CYP2D6 genotyping technologies."

The xTAG CYP2D6 Kit is the second test of its kind to be cleared by FDA. It is a qualitative genotyping assay that can simultaneously detect and identify a panel of single-nucleotide polymorphism (SNP) variants found within the CYP2D6 gene. It also identifies gene rearrangements associated with deletion and duplication genotypes.

The xTAG CYP2D6 assay features a simple laboratory workflow and provides accurate results in 8 hours. It is based on Luminex's flexible xMAP® Technology and is designed to be used on the widely distributed Luminex 200 system. It is uniquely suited for laboratories that offer cytochrome P450 drug metabolism testing services to physicians including psychiatrists, hospital pharmacologists, oncologists and general practitioners, who may treat patients with medical therapies that are metabolized all or in part by CYP2D6.

The first in a line of CYP products Luminex is developing; the xTAG CYP2D6 Kit is now commercially available from Luminex Molecular Diagnostics and its distribution partner, Fisher HealthCare.

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