WASHINGTON—The FDA announced that it will allow the binx health IO CT/NG Assay to be used to diagnose adults with chlamydia and gonorrhea at the point of care.
This latest move, which makes the binx IO assay the first test for these sexually transmitted infections approved for use in physician offices, community clinics, urgent care settings, and outpatient health facilities, is the result of the agency granting the test a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). With this waiver, the test can be used by physicians trained in the test procedure in any health care facility operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
“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,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
The binx IO assay, which was originally approved in 2019, uses female vaginal swabs and male urine specimens to detect the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which are the culprits behind chlamydia and gonorrhea, respectively.
“The test is performed while the patient is present, providing an actionable result in approximately 30 minutes,” the FDA explained. “The test’s performance was evaluated in females 16 years and older and in males 17 years and older and was demonstrated to be comparable to tests performed in a CLIA certified laboratory that meets the requirements for high or moderate complexity testing.”
The binx IO assay is manufactured by binx health.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,730,190,28,192,725,925
