Genetics & Genomics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

The company submitted the platform and gastrointestinal panel to the US Food and Drug Administration for clearance earlier this year.

The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.

The test cartridge runs on the company's Unyvero platform and covers 103 diagnostic targets for various pathogens and markers of antibiotic resistance.

The firm said that its Cobas CT/NG real-time PCR assay is the first available in the US for the testing of sexually transmitted infections on its 6800 and 8800 systems.

The test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes and covers 15 common tumor types.

Researchers have treated an X-linked genetic disease affecting three babies in utero, Stat News reports.

The Associated Press reports that the US Centers for Disease Control and Prevention is beefing up sequencing as a tool to investigate foodborne illnesses.

Researchers have sequenced samples from ancient toilets to study past eating habits and health, NPR reports.

In Nature this week: ash dieback disease fungal genome, and more.