Antelope's founder said that being spun off by MyCartis gives his company the focus it needs to launch tests for use in homes and doctors' clinics.
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.
MyCartis said that the new company, Antelope Dx, is developing a home test to diagnose Chlamydia trachomatis and Neisseria gonorrhea.
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.
Some at-home infectious disease tests and sample collection kits exist in a murky regulatory realm, and their sale to patients is troubling laboratorians and clinicians.
The Cobas TV/MG test detects Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in symptomatic and asymptomatic patients.