Luminex has commercially launched its first pharmacogenetic test, the xTAG CYP2D6 Kit, which recently received 510(k) clearance from the US Food and Drug Administration (FDA).
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 new test enables a personalised medicine approach to help physicians manage patients for whom they may prescribe certain drugs that are metabolised by the enzyme cytochrome P450 2D6, Luminex said.
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 results in 8 hours. It is based on Luminex’s flexible xMAP Technology and is designed to be used on the 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 metabolised 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.