Health Canada | GenomeWeb

Health Canada

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.

NEW YORK (GenomeWeb) — IMDx said today that it has received three additional licenses for sale and distribution of its molecular tests for the Abbott m2000 platform outside the US and EU.

NEW YORK (GenomeWeb) – Roche announced after the close of the market on Tuesday that Health Canada approved the cobas 4800 HPV Test as a first-line primary screening test for cervical cancer in women at least 25 years old.

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