NEW YORK – Binx Health today announced that the US Food and Drug Administration has granted 510(k) clearance for its Binx io platform, a rapid, qualitative, and fully automated test for use in point-of-care and clinical laboratory settings.
The test — which uses PCR amplification and electrochemical detection — provides sample-to-answer results in about 30 minutes for the detection of chlamydia and gonorrhea, two highly prevalent sexually transmitted infections, the firm said. The platform uses female vaginal swab samples collected by a clinician or self-collected by a patient in a clinical setting.
Binx Health President and CEO Jeff Luber said in a statement that "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."
The company said that standard CT/NG testing typically involves lengthy wait times from sample to result, often with up to seven-day turnaround times and with up to 40 percent of patients that receive positive test results not returning for treatment once they leave a physician's office.
The Binx Health diagnostic platform consists of a benchtop instrument and single-use, assay-specific cartridge that can process an unprocessed patient sample with no user interaction once the sample is added to the cartridge, according to Binx. The platform contains all reagents needed for the assay. It can multiplex up to 24 targets and requires no calibration or maintenance, the firm said.
In a recent multi-center clinical trial including 17 evaluation centers and more than 1,500 symptomatic and asymptomatic female patients, the Binx io platform showed a 96.1 percent sensitivity and 99.1 percent specificity for chlamydia and 100 percent sensitivity and 99.9 percent specificity for gonorrhea, the firm said.
The firm had announced in May that it received CE marking for the chlamydia and gonorrhea test running on its platform.