Everlywell was one of the first startups to announce that it was working on a self-administered COVID-19 diagnostic kit at home, but it first sought to ship kits before authorities clearly indicate that this was not in accordance with its guidelines. Everlywell then decided to work with the FDA to obtain an appropriate emergency use authorization for its kits before sending them to consumers, and this approach has paid off, the US drug regulator Today issuing an EUA for Everywell's technology.
EverywellThe COVID-19 Test Home Collection Kit is the first self-contained sample collection kit to have obtained an appropriate EUA by the FDA. Other kits were used thanks to a collection prescribed and directed by a doctor, and others were still specifically authorized for use with a single test (when the supplier of the kit and the test is the same ). This approval is unique because Everlywell offers its sample kit independently of any specific test laboratory, and can work with a variety of laboratories to potentially provide a larger test footprint.
The test kits are then sent to one of two laboratories currently authorized by separate EUAs for COVID-19 tests, and the administration notes that this could extend to others Test providers in the future if they apply for an EUA and provide the required data that goes hand in hand. with the verification required for this emergency approval. The FDA cites Everlywell's work in collecting and presenting study data, including those supported by the Bill and Melinda Gates Foundation, to show that samples taken at home using its method of Nasal swab specimens remain stable during shipment.
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This data is also now available to those looking to provide offers of similar test kits, notes the FDA, which should reduce the burden of proof for anyone seeking authorization for a competing product. This could potenti ally open up further testing, thereby reducing a bottleneck that many public health professionals see as one of the main drivers of a successful recovery.
"Authorizing a COVID-19 home collection kit that can be used with multiple tests in multiple labs not only provides increased patient access to the tests, but also protects others from harm. potential exposure, "said Jeffrey Shuren, MD, JD, director of the FDA Center for Radiation Devices and Health in a statement provided to Heaven32 . "Today's action is also another great example of public-private partnerships in which data from a privately funded study has been used by industry. to support a request from EUA, which saves us precious time in the pursuit of our fight against this pandemic. "