binx molecular point-of-care platform poised to transform care for chlamydia and gonorrhea, the two most tested for sexually-transmitted infections
Boston, MA, February 16, 2021
A first-of-kind FDA-cleared infectious disease platform, the binx io provides results in about thirty 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 thirty-five 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 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 has also completed its CLIA waiver study and submitted a request to the Food and Drug Administration (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,” said 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.”
binx health has partnered with global healthcare leader McKesson for the sale and distribution of the binx io platform.
For more information about binx io, visit mybinxhealth.com/point-of-care or contact email@example.com.