The Aptima BV test detects bacterial vaginosis and the Aptima CV/TV detects and differentiates candida infections from trichomonas.
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 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.
In a cartoon, Vox explores the lack of women among this year's winners of the Nobel Prize.
Science reports a new US defense bill would establish two groups aimed at combating foreign influence on research.
Nature Biotechnology discusses promising early results from two clinical trials of CRISPR-based therapy for β-thalassemia and sickle cell disease.
In Cell this week: analysis of tissue clones, metagenomic studies of ocean water samples, and more.