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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.
Novel Microdevices is developing a portable, sample-to-answer instrument that is designed to perform molecular testing on untreated patient samples.
The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver.
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 FDA cleared the point-of-care Binx io platform for the detection of chlamydia and gonorrhea in male urine specimens.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
The firm said it is turbocharging the lateral flow format with sensitivity and cost suitable for over-the-counter STI testing.
The Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.