The assay, which was CE marked last month, qualitatively detects group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments.
At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.
Myriad CEO Mark Capone said earnings during the quarter exceeded expectations based on strong volume growth from hereditary cancer and new products.
The genetic testing community is having a tough time deciphering FDA's intentions based on its authorization of 23andMe’s PGx test and a recent safety alert.
Some of the metrics used for the PrecisionFDA challenges have begun making their way into broader use, and additional competitions are planned.
Time reports that some experts have raised concerns about 23andMe's new direct-to-consumer pharmacogenetic tests.
The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.
The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.
The fully automated system has 12 independent thermal cyclers and runs the firm's diagnostic kits, but it can also operate as an open instrument.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
A New Zealand minister says the country's genetic modification laws need to be re-examined to help combat climate change, the New Zealand Herald reports.
A new analysis finds some cancers receive more nonprofit dollars than others.
An Australian mother's conviction in the deaths of her children may be re-examined after finding that two of the children carried a cardiac arrhythmia-linked gene variant.
In Science this week: comparative analysis of sex differences in mammal gene expression, and more.