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 test detects Group A Strep in throat swab samples using the firm's rapid molecular diagnostics instrument called Revogene.
Direct-to-consumer genetic testing firm 23andMe has a newly cleared colorectal cancer risk test.
The FDA said it is the first test authorized to test for M. genitalium, a slow-growing bacteria that is difficult to detect with traditional laboratory methods.
The clearance enables 23andMe to report on the two most common variations in the MUTYH gene influencing MAP, which increases risk of CRC development.
The molecular test detects and differentiates Bordetella pertussis and Bordetella parapertussis from fresh and frozen nasopharyngeal swab samples.
The test is the second of three panels intended to detect pathogens that cause the bloodstream infections that can lead to sepsis.
The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The molecular test detects a form of herpes virus that can infect newborns and cause deafness.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
In PLOS this week: preconception carrier screening program results, comparative genomics-based analysis of Elizabethkingia meningoseptica, and more.
Canadian regulators are beginning to share information from new drug studies, Undark reports.
In a column at the Dallas Morning News, the Stanley Medical Research Institute's E. Fuller Torrey says the Human Genome Project hasn't delivered on promised results.
Researchers explore a possible genetic cause for some cases of sudden infant death syndrome, KOMO News reports.