NEW YORK – The US Food and Drug Administration announced Tuesday that it has granted CLIA waiver to the Binx Health rapid point-of-care assay for detection of chlamydia and gonorrhea.
The assay, called the Binx Health io CT/NG Assay, runs on the io instrument and detects and distinguishes Chlamydia trachomatis and Neisseria gonorrhoeae in approximately 30 minutes using either female vaginal swab or male urine specimens.
The CT/NG test and io instrument — which uses PCR amplification and electrochemical detection — was initially granted 510(k) clearance by the FDA in 2019 for point-of-care testing of specimens from females. It was subsequently granted clearance in 2020 for specimens from males.
The FDA noted in a statement on Tuesday that the assay can now be used in point-of-care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation. These may include physician offices, community-based clinics, urgent care settings, and outpatient health care facilities, FDA said.
"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," said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.