The test is the first near-patient assay for M. genitalium, and can also guide treatment by detecting antibacterial resistance markers.
The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.
The firm said its platform provides sample-to-answer results for two of the most frequently tested sexually transmitted infections, enabling rapid testing and treatment.
Formerly known as Diassess, the Emeryville, California-based startup will use the funding to finance regulatory clearances and early commercialization.
Danaher's life sciences revenues grew 6 percent, while its diagnostics revenues rose nearly 5 percent, including an increase of more than 20 percent at Cepheid.
The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
The Cobas TV/MG test detects Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in symptomatic and asymptomatic patients.
The moves come in the wake of an FBI search of the company's San Francisco office as part of an investigation into its billing practices.
The firm said that its point-of-care test delivers laboratory-quality results in about 30 minutes and could be used in the home and other settings.
The firm said its new molecular platform, which offers random-access testing, high throughput, and a broad menu has the potential to replace multiple instruments in molecular labs.
23andMe has a holiday popup shop at a mall and could open additional stores, Bloomberg reports.
By studying koalas and a retrovirus that infects them, researchers may have uncovered a new sort of 'immune response' that occurs at the genomic level, Agence France Presse reports.
NPR reports that the first person in the US given a gene editing-based therapy for a genetic disorder is heading home.
In Science this week: ancient genomes reveal social inequality within individual households, new method for quantifying genetic variation in gene dosage, and more.