Health Canada

The test is the first to be approved for the company's second-generation molecular detection system, but can also be run using the first-generation system alongside other existing assays.

The oncology assay is the first from Roche using either plasma or tumor tissue samples and identifies 42 mutations in the EGFR gene.

The platform and the assay were cleared by the US Food and Drug Administration in October and were launched in the US shortly thereafter.

The Canadian approval comes more than a year after the FDA cleared for marketing the MiSeqDx system, the two CF assays, and sample prep kit.

The molecular diagnostic test identifies influenza virus A subtypes H1 and H3, influenza B, and human respiratory syncytial viruses A and B.

The xTAG CYP2D6 kit runs on the Luminex 100/200 instrument and helps physicians determine drug treatment strategies. 

The assay is now approved for testing composited samples of ground beef.