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Luminex Gets Canadian Approval for Drug Metabolism Genotyping Assay

NEW YORK (GenomeWeb) – Luminex today announced it has received a Health Canada Class 3 Device License for the xTAG CYP2D6 kit, a comprehensive in vitro diagnostic assay that analyzes a patient's cytochrome P450 2D6 (CYP2D6) genotype.                              

The test uses DNA extracted from a blood sample and runs on the Luminex 100/200 instrument. Results aid physicians in determining therapeutic strategies for patients who metabolize drugs differently because of the gene product, the firm said in a statement.

CYP2D6 is a clinically important gene that encodes a drug-metabolizing enzyme. The CYP2D6 enzyme metabolizes more than a quarter of the drugs in use today, including cardiovascular and anti-cancer drugs, anti-psychotics, anti-depressants, pain medications, and beta blockers. Different CYP2D6 genotypes can result in different abilities to metabolize drugs, leading to undesirable effects such as drug toxicity, adverse reactions, or inadequate therapeutic effect.

The new version of the kit features an updated software algorithm that detects all 17 genotypes that the assay is cleared for, including deletion and duplication genotypes.

The latest version of the test was approved by the US Food and Drug Administration in July 2013.

In 2014, Laboratory Corporation of America announced it would offer drug metabolism testing using the xTAG CYP2D6 test.