Assurance Scientific Laboratories has been approved by the Food and Drug Administration as one of two laboratories to test specimens for Everlywell COVID-19 at-home test collection kits.
The FDA issued emergency use authorization for the test and the lab testing facilities, Birmingham-based Assurance Labs and California-based Fulgent Therapeutics, in mid-May. The test enables individuals to take a nasal sample at home and send it in directly to the lab for processing.
“This process will allow expanded access, limit exposure and preserve valuable personal protective equipment without compromising sample integrity,” said Dr. Chad Austin, co-founder and owner of Assurance Labs.
Assurance Labs began testing for COVID-19 on March 11, making it the first commercial lab in Alabama and one of the first in the country to begin testing. Since then, it has increased capacity and can process upwards of 5,000 tests per day.
Everlywell, based in Texas, is a digital health company that offers consumers access to at-home lab tests. They plan to make the at-home COVID-19 test available by the end of May.
“The EUA comes after an exhausting amount of work and collaboration to fulfill requirements set forth by the FDA to ensure that all aspects from ordering, delivery, sample collection and shipping proved to be safe, accurate and reproducible,” said Dr. Ty Thomas, co-founder and lab director for Assurance Labs. “We are grateful for the partnership with Everlywell, with whom we have been working alongside since early March.”
Assurance was authorized to test the samples with their Assurance SARS-CoV-2 Panel, while Fulgent will test the samples with their Fulgent COVID-19 by RT-PCR Test.
“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”
Assurance Scientific Laboratories develops and provides rapid diagnostic services for clinicians, hospital systems, private entities, long term care facilities and other reference labs. They specialize in molecular diagnostics and microbiology and test for more than 100 different pathogens, offering several different panels. They also perform culture and antibiotic sensitivity testing.