Binx Health said that when it received FDA CLIA waiver, it already had a strategic partner for sales of its POC platform and chlamydia and gonorrhea tests.
The company is currently working on multiple infectious disease products, including a panel for sexually transmitted infections and one for SARS-CoV-2.
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.
