Diagnostics, Startups

Everlywell gets green light to sell at-home Covid-19 test kit without prescription

After Everlywell received an emergency use authorization last year from the FDA for its at-home collection kit, the agency gave Everlywell the green light to sell its test kits without requiring a prescription.

Everlywell got an emergency use authorization from the FDA to sell its Covid-19 test kits without a prescription. Photo credit: Everlywell

This article has been updated with comments from Everlywell CEO Julia Cheek and information on the number of tests provided. 

The Food and Drug Administration ok’d another at-home Covid-19 test to be sold over the counter. At-home testing company Everlywell received an emergency use authorization from the Food and Drug administration on Wednesday to offer its Covid-19 test kits to patients without a prescription.

The Austin-based startup initially got the green light for its at-home test kits last May, but users still had to be screened by a doctor and have Covid-19 symptoms to purchase the test. Now, people without symptoms or known exposure to the virus will be able to use it.

“With the FDA’s support for this new indication, we can now serve even more Americans with Covid-19 testing that’s delivered right to their doors and available where they shop and work,” Everlywell Founder and CEO Julia Cheek said in a news release.

Users swab their nose and send in the sample, which is then processed at one of Everlywell’s partner labs. It takes one to two days to get results from the rt-PCR test. If users have a positive or an undetermined result, they’re contacted by a clinician.

On Everlywell’s website, tests are priced at $109 — generally more costly than most antigen test alternatives. The company also plans to partner with retailers to sell it over the counter.

Since the start of the pandemic, the FDA has mostly limited tests to patients with Covid-19 symptoms, as tests of asymptomatic patients are more prone to false negatives.  But the agency has recently cleared a handful of at-home tests that don’t require prescriptions, including a rapid antigen test developed by Ellume.

In a summary of the EUA for Everlywell’s test kit, the FDA reported that 95% of test kits were sent to the lab successfully, while a small number lacked enough sample or had the incorrect name on the tube.

Before the pandemic, Everlywell shipped common wellness tests — such as STD tests, allergy and food sensitivity tests — to users’ homes. That business has grown in the last year,  in addition to its Covid-19 testing efforts.

“Although Covid-19 saw us grow a novel part of our business due to us offering Covid-19 testing, our core business exploded right alongside it – up over 200%. We do believe the pandemic has fundamentally shifted behavior toward virtual care, but we were already part of this trend pre-pandemic; the pace has just further accelerated,” Cheek wrote in an emailed statement.

As of December, the company had distributed more than 1 million at-home test kits. It also raised $175 million in new funding to back this effort.