Assurance Scientific Laboratories has received emergency use authorization from the U.S. Food and Drug Administration for its At-Home COVID-19 Test.
The Birmingham-based commercial lab’s at-home test allows anyone 18 and older to purchase the At-Home COVID-19 Test kit and collect a nasal swab sample. After registering the kit, the sample is sent to the company’s lab for testing. Results will be available online within 48 hours.
“This new authorization will allow consumers to have kits on hand before they are sick, cutting the wait time on getting results,” said Dr. Chad Austin, co-founder of Assurance Scientific Laboratories.
Assurance Scientific Laboratories is also working to validate a test for clinical use that was developed by Molecular Designs. The PCR test is capable of differentiating the UK variant of COVID-19. Studies have shown that the UK variant is very contagious and rapidly spreading in the United States.
Currently, to detect the UK variant, labs have to sequence the viral genome from positive SARS-CoV-2 tests, an expensive and slow process.
Assurance hopes to have Molecular Designs’ test validated by the end of the month. It is currently working with the FDA and will submit the test for emergency use authorization.
“There are four signature mutations in the UK variant that our test targets. Robust amplification of our new test represents the presence of the UK variant in the patient sample,” said Greer Massey, chief scientific officer for Assurance Scientific Laboratories. “We want to use this test as soon as possible, but the test must first pass the rigors of clinical validation to prove it reliably and consistently works.”
