Startups, Health Tech, Health Services

Startups pause at-home tests after new FDA guidance

Everlywell, Nurx, and a bevy of other companies had begun marketing at-home tests as the U.S. still faces a shortage. But they had to stop after the Food and Drug Administration clarified that it had not approved at-home testing.

Startups that rushed to offer at-home Covid-19 tests are now dialing back their efforts, after the U.S. Food and Drug Administration clarified on Friday that they were not approved.

In an announcement warning the public against fraudulent tests, the FDA also noted that it “…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.”

Part of the concern with at-home collection is that users who don’t swab themselves correctly might get a false negative result, mistakenly thinking they don’t have Covid-19. In other cases, someone who takes a test too early could also get a false negative result.

With the U.S. facing a shortage of testing, several companies created their own in-home test kits. They had planned to partner with labs that had received emergency use authorization from the FDA, and would send sample collection kits to patients’ homes, so they could collect a sample and send it off for testing.

Now, many of these startups are changing their plans.

Everlywell, an Austin-based startup that made splashy headlines last week when it said it would offer at-home Covid-19 testing, pivoted quickly. As of last week, the company had assembled about 30,000 at-home collection kits, charging $135 apiece.

For now, the company said it would offer its test kits to hospitals and healthcare, with the tests being administered by a medical professional.

“The national response around COVID-19 testing has been evolving daily; Everlywell has adapted in response. Starting on Thursday evening, we had begun plans to allocate some portion of our collection kits to healthcare providers based on the response we received to our announcement,” the company wrote in a statement. “After reviewing this past weekend’s statements from the White House and the FDA, we made the decision to allocate our initial supply of COVID-19 collection kits to hospitals and healthcare companies with workers on the front lines.”

Everlywell said it still plans to work with the FDA on a path to approval for sample self-collection.

Other startups are putting testing on hold entirely. Nurx, a San Francisco-based company that provides at -home testing and prescription delivery, said it had stopped providing any at-home Covid-19 testing kits, along with its partner Molecular Testing Labs.

“Molecular is in direct communication with the FDA regarding this most recent guidance and they continue to have high confidence in the test characteristics and accuracy of its self-collection COVID-19 test,” the company said in an emailed statement.

Primary care startup Carbon Health also dialed back on its testing. The company initially said it would offer mail-order testing for $167, but announced on Friday that it would discontinue distributing at-home test kits immediately after seeing the new FDA guidance. It had already shipped kits to 50 patients.

Now, Carbon Health is encouraging them to instead get tested in-person at one of its locations by a clinician.

“Our goal was to facilitate at home specimen collection in order to keep patients safely in their homes while also providing another avenue for patients to be tested,” the company said in an email sent to patients. “This is a very dynamic time and we are working tirelessly to work with new partners to expand COVID-19 testing for our communities, as soon as possible.”

Photo credit: Everlywell