Luminex Corporation Launches New FDA Cleared Pharmacogenetic Diagnostic Test
News Nov 18, 2010
Luminex Corporation has 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.
"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 reactions 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 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.
The xTAG CYP2D6 Kit is not indicated for stand-alone diagnostic purposes and is not intended to be used to predict drug response or non-response.