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.

Originally published Oct. 31.
NEW YORK (GenomeWeb) – Spartan Bioscience is gearing up to commercialize its CYP2C19 test in Canada in the point-of-care setting, a previously untapped market for the company.

NEW YORK (GenomeWeb) – Health Canada has approved Spartan Bioscience's non-invasive genetic test for determining within an hour whether a person has CYP2C19 genetic mutations.

NEW YORK (GenomeWeb) – GenDx announced that it has received Canadian ISO certification, enabling the firm to start the registration procedure for its Sanger and next-generation sequencing HLA reagents and software for diagnostic purposes in Canada.

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The US Food and Drug Administration has new guidelines that enable some gene and cell therapies to undergo expedited review, according to the New York Times.

Using gene drives to control invasive species might be too risky, an initial advocate of the approach says.

Researchers have grown tumors in 3D cell cultures to better understand cancer, the Economist reports.

In Science this week: intellectual property experts argue patent battles such as the one over CRISPR are wasteful, and more.