Boston-based Binx Health has partnered with global healthcare leader McKesson for the sale and distribution of the binx io platform in the United States.
A first-of-kind FDA-cleared infectious disease platform, the binx io provides results in about 30 minutes, which enables diagnosis and treatment of chlamydia (CT) and gonorrhea (NG) to take place in a single visit. The binx io’s test performance has been demonstrated to be on par with central laboratory testing.
Today, about 35 million CT/NG tests are processed at central laboratories, with virtually all patients leaving a clinic before results are ready. Under this traditional care model, up to 40% of patients who are subsequently determined to be positive do not return for treatment once they leave the clinic, leading to further infection spread and comorbidities.
The company says the binx io is poised to change all of that, by delivering results within the time window of a typical OB-GYN visit. Initial distribution of the binx io will be into settings that are certified to perform moderate or high complexity diagnostic tests under the Clinical Laboratory Improvement Amendments (CLIA). The binx io platform also may be used in satellite point-of-care (POC) settings designated under such moderate or high complexity certificates. Binx also completed its CLIA waiver study and submitted a request to the FDA in 2020 to classify the platform as CLIA waived, which, upon FDA clearance, will enable distribution to the 200,000+ CLIA-waived locations nationwide.
“At Binx we consider evidence-based care and consumer convenience central to all we do,” says Jeffrey Luber, Binx Health’s chief executive officer. “Today’s announcement is a win-win-win for clinics, patients, and the public health and we are especially proud of this new distribution partnership for national reach.”
For more information, visit Binx Health.
Featured image: A first-of-kind FDA-cleared infectious disease platform, the binx io enables diagnosis and treatment of chlamydia and gonorrhea to take place in a single visit. (Courtesy: Binx Health)