The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
The agency anticipates that the new pathway will promote comparisons with modern products rather than relying on older predicates.
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 World Health Organization has announced the members of its gene-editing committee, according to NPR.
DARPA is working on developing algorithms that gauge the credibility of research findings, Wired reports.
The American Society of Breast Surgeons recommends all women diagnosed with breast cancer be offered genetic testing, the Washington Post says.
In Science this week: comparison of modern, historical rabbit exomes uncovers parallel evolution after myxoma virus exposure; and more.