Luminex xTAG CYP2D6 pharmacogenetic kit

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.

The 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.

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 kit helps identify individuals who possess both common and rare CYP2D6 poor-metaboliser variants. Abnormal metabolisers 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 xTAG CYP2D6 assay features a simple laboratory workflow and provides accurate results in 8 h. It is based on the company’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 kit is not indicated for stand-alone diagnostic purposes and is not intended to be used to predict drug response or non response.