The Food and Drug Administration (FDA) has granted 510(k) clearance to binx io (binx health) for women’s health, a molecular point-of-care diagnostic testing platform for detecting chlamydia and gonorrhea in approximately 30 minutes.
The binx io platform is a rapid, fully-automated test that requires no calibration or maintenance; no additional steps are needed once the single-use, assay-specific cartridge is loaded into the instrument. It is intended for use at point-of-care or clinical laboratory settings using female vaginal swab samples that are collected either by a clinician or self-collected by a patient in a clinical setting.
The 510(k) clearance was granted based on a recent multicenter trial which included 17 evaluation centers and more than 1500 symptomatic and asymptomatic patients. In the study, the accuracy and reliability of binx io was compared with current central lab standard of care systems for chlamydia and gonorrhea. According to the Company, results showed binx io was comparable to central lab testing with a 96.1% sensitivity and 99.1% specificity for chlamydia and 100% sensitivity and 99.9% specificity for gonorrhea testing in women tested.
Commenting on the approval, Jeff Luber, President and CEO of binx health said, “With the ‘front door’ of healthcare increasingly moving to near-patient settings, today’s FDA clearance puts the power of rapid onsite care where consumers need it most—in the communities where they live, work and shop.”
For more information visit bink-io.com.
This article originally appeared on MPR