The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.
The test will be used to identify which advanced or metastatic breast cancer patients with PIK3CA mutations are likely to respond to Novartis' alpelisib.
The Cobas TV/MG test detects Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in symptomatic and asymptomatic patients.
The Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG assays have now been cleared for use in throat and rectum samples.
The QiaStat-Dx system will now be commercially available in the US along with a panel that detects more than 20 respiratory viral and bacterial pathogens.
The firm said that its HSV and varicella-zoster virus assay delivers answers for related herpes conditions in about an hour.
The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.
Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.
Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.
In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.