binx health has received an 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 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.
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"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."