The FDA announced today that it authorized the Binx Health IO CT/NG assay at point-of-care settings to diagnose STIs.
Point-of-care settings include physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance or certificate of accreditation, according to a news release.
The test uses female vaginal swabs and male urine specimens to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which case the sexually transmitted infections (STIs) chlamydia and gonorrhea, respectively.
While the patient is present, the test is performed and it provides an actionable result within approximately 30 minutes. The test was evaluated in females 16 years of age and older and in males 17 and up and was demonstrated to be comparable to tests performed in a CLIA certified laboratory that meets requirements for high or moderate complexity testing.
“The ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections, which is a major milestone in helping patients,” FDA director of the Office of In Vitro Diagnostics & Radiological Health Dr. Tim Stenzel said in the release. “More convenient testing with quicker results can help patients get access to the most appropriate treatment. According to the CDC, one in five Americans are diagnosed with sexually transmitted infections every year, which is why access to faster diagnostic results and faster, more appropriate treatments will make significant strides in combatting these infections.”