FDA Clears Binx Health Diagnostic for STDs

The FDA granted Binx Health another 510(k) clearance for its Binx io platform, clearing the fully automated point-of-care test for chlamydia and gonorrhea.

The test uses polymerase chain reaction (PCR) amplification and electrochemical testing to detect the common STDs.

It delivers results in about a half hour, using vaginal swab samples that can be collected by a physician or by the patient.