Vestavia Hills laboratory chosen by the FDA as one of two labs in the U.S. to test COVID-19 at- home collection kit specimens

Assurance Scientific Laboratories has been approved by the FDA as one of two laboratories to test specimens from Everlywell COVID-19 at-home test collection kits. In early June, the FDA issued emergency use authorization (EUA) for this test and for the COVID-19 lab testing by Assurance Labs. This test enables individuals to take a nasal sample at home and send 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 Chad Austin, M.D., Co-founder and Owner of Assurance Labs.

“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 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 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 for COVID-19. Assurance Labs has increased capacity and can process upwards of 5,000 tests per day. Everlywell, based in Austin, Texas, is a digital health company that offers consumers access to at-home lab tests.