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.
In an against-all-odds twist, a researcher studying exceeding rare FOXG1 mutations discovers her daughter has the syndrome.
An effort by Genomics Medicine Ireland is creating a database of diseases based on the genomics of people in Ireland. It now is looking into the possibility of including Scotland in its work.
In recent weeks, the direct-to-consumer genetics firm has rolled out a health hub where customers can share information concerning 18 common health conditions.
In PLOS this week, new genes associated with prostate cancer risk, genetic patterns in M. bovis, and more.