Everlywell Inc. stepped back from its announcement that consumers could access at-home testing for COVID-19 starting on March 23, 2020, following a U.S. FDA update that cautioned against fraudulent at-home tests. In response, the test is now restricted to health care professionals and hospitals or health care companies who “commit to providing the test for free to health care workers and high-risk, symptomatic patients affected by the testing shortage,” the Austin, Texas-based company said.

“As the COVID-19 public health emergency continues to worsen with community spread across the United States, there is an unmet medical need to broaden the access to testing for SARS-CoV-2 coronavirus in a responsible manner to complement and help alleviate the potential overload on health care systems and health care providers if testing was only available in the limited clinical setting,” Everlywell’s Chief Medical and Scientific Officer Frank Ong told BioWorld.

Following its initial announcement on March 18 that 30,000 at-home collection kits with telehealth diagnosis would be available for consumers to order in five days, the company reported overwhelming interest from health care professionals, including “thousands of notes from physicians, nurses, and health care workers on the front lines asking Everlywell for access to these tests – both for their highest risk patients and for themselves.” As a result, it had planned to reserve a proportion of its tests for health care workers.

Developments over the weekend changed those plans.

“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space,” the FDA said on March 20.

The FDA statement and the White House’s Coronavirus Task Force’s call over the weekend to prioritize testing of frontline health care workers and especially vulnerable, symptomatic patients led the company to allocate the entire initial supply of tests for those two groups.

Health care professionals and hospitals can order the test on the company’s website.

Everlywell expects to ramp up to support testing and telehealth diagnosis for 250,000 people per month in the coming months.

Working with the FDA

The company remains committed to making the COVID-19 test available in short order to consumers who meet the CDC’s guidelines for testing.

“We share the FDA’s concern regarding fraudulent tests and are working directly with the FDA to increase the availability of COVID-19 testing,” Everlywell said in a statement announcing the change in plans. “During this process, we will continue to provide urgently needed tests to qualifying hospitals, health care companies, and medical facilities. We are partnering with the FDA in our shared mission to provide safe and accurate COVID-19 testing for all Americans who need it.”

Test development

Everlywell provides at-home testing for a wide range of conditions, including thyroid disorders, food sensitivity, metabolism, folic acid, Lyme disease, heart health, cholesterol and lipids, hepatitis C, sexually transmitted infections, and blood glucose.

"Everlywell was founded to give people affordable, convenient access to lab testing. Never has our mission been more important," said Julia Cheek, founder and CEO of Everlywell. "Our team has been working around the clock with top scientists and laboratories in the nation to develop a test that we will make available at the lowest price possible while covering our costs, at no profit to the company. We have also reached out to government and public health officials to explore possibilities to provide it for free."

The company’s COVID-10 rt-PCR test was developed by partner laboratories using the CDC-recommended methodology, while operating under the emergency use authorization guidelines issued by the FDA on Feb. 29. All the company’s partner labs for the COVID-19 test are CLIA-certified and many already offer infectious disease assays for other respiratory viruses.

The test is shipped with everything needed to collect a sample at home and safely send it via overnight delivery to one of the partner labs. Secure results will be available online within 48 hours of receipt of the sample by the lab. Telehealth consultations with an independent, board-certified physician is included in the cost for those with positive results.