As part of the approval, DermTech will market and sell the pigmented lesions assay in Canada, while samples will be processed at the company's lab in California.
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.
A new study in JAMA finds that genetic tests might not be able to determine what diet is right for someone seeking to lose weight.
A genome-wide association study that linked common genetic variants to salivary gland carcinoma risk has been retracted, according to Retraction Watch.
Vampire bats' ability to live off blood is etched in their genomes and gut microbiomes, the Scientist reports.
In Genome Biology this week: peopling of the Sahara, epigenetic reprogramming analysis of liverwort, and more.