August 12, 2019 -- Binx Health's point-of-care binx io molecular diagnostic instrument enabling rapid testing and reporting of chlamydia and gonorrhea infections in women is now cleared by the U.S. Food and Drug Administration (FDA).
The polymerase chain reaction (PCR) product includes a benchtop instrument with a single-use, assay-specific cartridge. Vaginal swabs may be collected by patients in a clinical setting or by laboratorians, and results are available within half an hour, according to the company.
The hope is that providing results while patients are in the office will help those who test positive for a sexually transmitted infection (STI) receive treatment, rather than patients slipping through the cracks after a delay in reporting, which is common in clinical practice.
The FDA clearance was supported by a trial of more than 1,500 female patients, in which testing had 96.1% sensitivity and 99.1% specificity for chlamydia and 100% sensitivity and 99.9% specificity for gonorrhea, the company noted.