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Everlywell receives FDA authorization for at-home coronavirus testing kit

Austin American-Statesman logo Austin American-Statesman 5/17/2020 Hojun Choi
a woman smiling for the camera: Julia Cheek is founder and CEO of Austin-based Everlywell, which recently received an emergency use authorization from the U.S. Food and Drug Administration for its at-home testing kit. [Courtesy of Everlywell] © Provided by Austin American-Statesman Julia Cheek is founder and CEO of Austin-based Everlywell, which recently received an emergency use authorization from the U.S. Food and Drug Administration for its at-home testing kit. [Courtesy of Everlywell]

Austin-based Everlywell has received authorization from the U.S. Food and Drug Administration for its at-home testing kit for COVID-19.

The company had been pursuing an emergency use authorization from the FDA — an expedited process for clearing products for public use — since March. The agency confirmed earlier Saturday through its website that Everlywell had received the authorization for its kit, which allows for self-collection of samples at home.

According to the agency website, Everlywell's newly authorized product is the only testing kit that can be used with other diagnostic tests that have been authorized by the FDA.

Everlywell's kits contain other testing equipment, such as nasal swabs, that have been approved by the FDA. The new kits will only be available to "individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider," according to the FDA website.

An Everlywell spokeswoman said the testing kit could pave the way for the company to be able to work with a large number of labs that can test for COVID-19.

Frank Ong, chief medical officer for Everlywell, said the company's existing network of clinical labs around the country will be central to its efforts to make at-home testing for COVID-19 more widely available.

"Since the beginning, we always thought that to provide the best turnaround time and consumer experience for at-home collection, we would have to have labs across the country," Ong said.

Ong said results of the tests could take 12-24 hours. Testing kits will be ready to be shipped out within the next few weeks, according to the company.

"This was a very innovative regulatory approach that the FDA put together for us," Ong said.

Everlywell CEO and founder Julia Cheek said the authorization of the testing kit can be a major step toward fighting the coronavirus pandemic.

"Widespread access to convenient testing will play a crucial role in this country's ability to address the pandemic and prevent overburdening our healthcare facilities," Cheek said in a written statement. "As the national leader in connecting people with high-quality laboratory testing, we are committed to preventing the spread of this virus in America."

The FDA announced in February that it would consider emergency use authorization for proposals involving diagnostic devices for the coronavirus.

Everlywell had announced in March that the company was ready to release as many as 30,000 at-home testing kits. The company had also put up a $1 million incentive to fuel research into the new kit.

That effort had been somewhat curtailed after the FDA announced that it had not authorized any type of home testing solutions for COVID-19.

But in April, the FDA announced that it had authorized its first diagnostic test kit in which a self-administered nasal swab sample could be used.

"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," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a written statement.

This report has been updated with additional comments from the chief medical officer of Everlywell.

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