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.
In February, Binx announced a distribution partnership with McKesson for the io and CT/NG assay. The firm is also collaborating with Sherlock Biosciences on a SARS-CoV-2 assay.