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FDA grants binx health CLIA-Waiver for its first-of-kind binx io platform for chlamydia and gonorrhea testing

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Posted on Alex Kramer / in News

binx health Enters into Distribution Agreement for National Launch of the FDA-cleared binx io

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%[1] 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 info@mybinxhealth.com.

About binx

binx health is a first-of-kind population health technology company that brings high quality convenient testing to the places where people live, work, study and shop. We work with large corporate partners and institutions to keep populations healthy and businesses and schools open. Our solutions broaden access to care for millions. Our point-of-care io platform puts central-lab quality testing solutions in the hands of clinicians everywhere, including the rapidly expanding ecosystem of retail health. Our suite of medically guideline-driven, at-home testing solutions bring high quality testing and population health tools and digital integration capability to large corporate partners and those unable to visit a clinic location. Our FDA cleared io platform is the first ever point-of-care tool for the detection of chlamydia and gonorrhea that provides central lab performance results in about thirty minutes. Our platform is highly flexible, easy-to-use and rapid, offering molecular point-of-care answers at central-lab quality performance and for the first time enabling single-visit test and treatment. We are currently expanding the platform COVID-19 testing combining our proprietary electrochemical detection with CRISPR methods. We are building solutions designed for the future of healthcare that lies at the nexus of testing convenience, rigorous science, and strong consumer relationships.

binx Media Contact

Michelle Searer
617-986-4929
michelle.searer@fleishman.com

Footnotes

[1] Huang W, Gaydos CA  et al (2012). Comparative effectiveness of
a rapid point-of-care test for detection of Chlamydia trachomatis among
women in a clinical setting. STI. 88. Published first online 14 Sept 2012. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3671871/