NEW YORK – Binx Health said on Thursday it has received a second 510(k) clearance from the US Food and Drug Administration for the Binx io molecular point-of-care platform for the detection of chlamydia and gonorrhea in male urine specimens.
The agency cleared the system in August 2019 for use with clinician and self-collected vaginal swab specimens.
The fully automated platform uses PCR amplification and electrochemical detection, and provides sample-to-answer results in about 30 minutes for the detection of chlamydia and gonorrhea. In a multicenter clinical trial conducted in 10 sites across the US, samples were collected from 922 male symptomatic and asymptomatic patients. Clinical study performance for the specimens run on the Binx io and compared to three FDA-cleared laboratory tests showed a 92.5 percent sensitivity and 99.3 percent specificity for chlamydia, and 97.3 percent sensitivity and 100 percent specificity for gonorrhea, Boston-based Binx said.
"In order to slow the growth of rising sexually transmitted infections, ease of use and rapid answers during a single clinical encounter are essential," Binx CEO Jeff Luber said in a statement. "Point-of-care testing will continue to be more widely adopted as a critical tool in infection control globally. With increasing numbers of large retail players moving into healthcare, we look forward to working with partners to expand onsite infectious disease testing for the millions who need it."