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Everlywell Inc. has received a critical federal authorization for its Covid-19 at-home collection kit that will quickly allow the Austin startup to process up to 50,000 test samples per week.
After months of negotiations with the U.S. Food and Drug Administration, Everlywell on May 15 received an Emergency Use Authorization for its Covid-19 kit. It marks a major milestone for the ambitious Austin startup, which raised a $50 million funding round in April 2019, and means Everlywell will be able begin processing tens of thousands of Covid-19 tests before the end of May.
“Widespread access to convenient testing will play a crucial role in the country’s ability to address the pandemic and prevent overburdening our healthcare facilities," said Julia Cheek, CEO and founder of Everlywell, in the company's May 18 announcement. "As the national leader in connecting people with high-quality laboratory testing, we are committed to fighting the spread of this virus in America."
The authorization comes roughly two months after Everlywell announced plans to launch its at-home Covid-19 collection kit. Once the FDA on March 20 offered guidance that the startup’s at-home test wasn’t yet permitted for use by the public, a rigorous stress test ensued to ensure that the collection kit was safe and effective for use by the public.
Meanwhile, Everlywell offered collection kits for frontline health care workers — the company said it is currently processing about 25,000 to 30,000 tests per day for health care organizations right now.
The FDA on May 15 also authorized a pair of diagnostic tests that can process the samples from Everlywell’s kits. California-based Fulgent Therapeutics LLC and Alabama-based Assurance Scientific Laboratories are the first two labs permitted to do so. Everlywell is hoping more labs will be authorized to test its kits in the coming weeks and months, allowing the startup to rapidly ramp up its testing capacity.
