FDA Discourages Using At-Home Coronavirus Test, Testing Companies Pause Sales

Everlywell and Nurx, two popular home testing companies announced they have created an at-home coronavirus test consumers can purchase.

On Friday evening, the FDA warned consumers it had “not authorized any test” for the coronavirus that people could buy and administer at home, so those hoping to test themselves from the convenience of their home will likely have to wait a few more weeks.

Everylwell said in a statement that it planned to have the tests available for individual consumers by March 23 but has since postponed that launch date to provide priority access to healthcare workers.

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“With recent briefings from the White House’s Coronavirus Task Force and the overwhelming response to our announcement from the medical community—it has become increasingly apparent there is a desperate need for healthcare workers on the frontlines to have priority access to testing for COVID-19,” the company said in a statement.

“For those reasons, we have made the decision to allocate the initial supply of COVID-19 Tests to healthcare companies with workers on the frontlines in order to get these tests in the hands of those who need them most urgently,” they added.

However, they still plan to cater to individuals and will be the first company to provide tests directly to consumers.

People requesting a test will be screened online with a telehealth physician from PWNHealth, who will rule out other respiratory diseases and review the request.

Once approved, a consumer can purchase the test for $135 — a fee the company says will be “no profit to Everlywell, and will be covered by participating HSA and FSA providers.”

“Everlywell has reached out to government officials and public health departments to see if the test can be made available for free,” they added in a statement.

The test will then be shipped to the customer who will collect their sample and ship it to a partner laboratory operating under the Emergency Use Authorization guidelines issued by the Food and Drug Administration.

Customers will receive their secure digital results within 48 hours, and “free telehealth consultations with an independent, board-certified physician will be available for those with positive results,” Everlywell said.

Nurx paused requests for their $181 coronavirus consultation and testing service due to the FDA’s warning against at-home kits.

While assuring that results of previous tests were accurate, Nurx wrote that “given new guidance from the FDA on March 21, specific to self-collection laboratory testing, Nurx and our longstanding and trusted laboratory partner Molecular Testing Labs have made the responsible decision to pause on providing any additional self-collection COVID-19 tests.”

It is unclear when Nurx will resume providing tests.

Article by Katherine Huggins