NEW YORK ─ Point-of-care diagnostics firm Binx Health said on Tuesday that it has partnered with global healthcare company McKesson for the sale and distribution of the Binx io molecular diagnostic testing platform in the US.
The point-of-care platform, which uses PCR amplification and electrochemical detection, was cleared by the US Food and Drug Administration in 2019. It provides results in about 30 minutes and enables the diagnosis and subsequent treatment of chlamydia and gonorrhea to take place in a single visit, according to Boston-based Binx Health.
Under the terms of the deal with Irving, Texas-based McKesson, the initial distribution of Binx io will be to settings that are certified to perform moderate- or high-complexity diagnostic tests under CLIA, Binx Health said. The platform may also be used in satellite point-of-care settings with such moderate or high complexity certificates, the firm added
Financial and other terms of the agreement were not disclosed.
Binx Health noted that last year it completed a study and submitted a request to the FDA to classify its platform as CLIA waived, which would enable distribution to more than 200,000 CLIA-waived locations nationwide.
Binx Health said it is expanding the Binx io platform to perform COVID-19 testing by combining electrochemical detection with CRISPR methods. In October, the firm obtained EUA for a SARS-CoV-2 at-home nasal swab collection kit.