The PCR diagnostic device is a palm-size, single-use, disposable device that detects N. gonorrhoeae and determines if it's susceptible to an antibiotic.
Roche will have non-exclusive access to SpeeDx's existing tests and technology to enable expansion of diagnostic products for antibiotic resistance in STIs.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
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.
