Luminex has received approvals from the US Food and Drug Administration (FDA) and EU authorities for the new version of xTAG CYP2D6 (Cytochrome P450 2D6) Kit.
An IVD assay, the xTAG CYP2D6 Kit analyses a patient's CYP2D6 genotype from a DNA of a blood sample to aid physicians in determining therapeutic strategy for drugs metabolized by the cytochrome P450 2D6 gene product.
CYP2D6 is an important gene that encodes a phase I drug metabolizing enzyme and metabolizes more than 25% of the drugs that are currently in use such as for cardiovascular, pains, and cancer.
Luminex president and CEO Patrick Balthrop said the test results that inform a physician on how a patient may react to a particular therapeutic are vital to improving patient care.
"Attaining FDA and CE clearance for xTAG CYP2D6 Kit demonstrates Luminex's commitment to offering diagnostics that optimize patient outcomes and lower overall health-care costs," Balthrop added.
Besides, the company has submitted xTAG 2C19 Kit to the FDA for review.
The CYP2C19 enzyme is responsible for the metabolizing various drugs used to treat ulcers, seizures, malaria and anxiety.
CYP2C19 enzyme is also partially responsible for metabolizing drugs including beta-blockers and some antidepressants.
Image: Luminex IVD cleared xTAG CYP2D6 Kit v3. Photo: Courtesy of PRNewswire.
