15 December 2020
Boston, Mass., December 15, 2020 - binx health, a first-of-kind population health technology company, announced today that it received an important amendment to its COVID-19 Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), this time for centralized specimen collection kit distribution and retrieval by large partners.
The FDA noted in binx’s amended EUA that the binx sample collection kit supports a “safe return to campuses and other settings (e.g., workplace) where other risk mitigations such as social distancing are less feasible.” The FDA added that, since students and employees are “co-located in a given setting, the kits can be centrally issued and collected.”
This significant EUA amendment brings with it the opportunity to efficiently reach millions of people for COVID-19 testing at scale. The Company’s existing EUA already permitted self-collection of nasal swab specimens at-home, but the latest amendment expressly includes centralized kit distribution and collection for efficient and broad reach and rapid test processing. binx is authorized to distribute its at-home COVID-19 sample collection kits to centralized distribution locations and to use its kit with laboratories designated by binx. This approach can empower universities and large employers to test populations effectively and, in conjunction with clinician oversight, make onsite, at-home, and in-dorm sample collection easy and convenient for millions.
“Fighting the spread of COVID-19 is as much about navigating complex logistics, promoting patient compliance, and ensuring effective communication as it is about the provision of high-quality testing,” said Jeff Luber, Chief Executive Officer of binx. “At binx, we make every link in the chain easy for our partners, patients, laboratories, and for broad populations at-risk. Our ‘white glove’, end-to-end platform is the key to ‘switching on care’ at scale both here and around the globe. This latest amendment to our EUA is another important step in the fight against COVID-19 and we applaud the FDA’s commitment to these types of critical initiatives.”
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.
This self-collection kit has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. I This self-collection kit has been authorized only for the self-collection and maintenance of nasal swab specimens as an aid in the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. I The emergency use of this self-collection kit in combination with the authorized test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1 ), unless the declaration is terminated or authorization is revoked sooner.
20 May 2022
20 May 2022
19 May 2022
18 May 2022