According to a report in the Statesman, the Austin-based medical diagnostics company called Everlywell has paused its testing for the COVID-19 coronavirus directly to consumers.
In a statement, the company wrote, “For the time being, Everlywell’s COVID-19 test will only be available to qualifying hospitals and healthcare companies who can commit to providing the test for free to healthcare workers and high-risk, symptomatic patients affected by the testing shortage.”
“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’s statement read. “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.”
Everlywell and its CEO Julia Cheek had announced its plan to start selling the testing kits directly to consumers. However, following their announcement, U.S. Food and Drug Administration “published a statement clarifying its stance on testing kits that can be self-administered.”
Following the FDA’s statement, Cheek said Everlywell is waiting for further directions from the FDA regarding self-collection. For now, it’s 30,000 kits will only be offered to facilities with medical staff who are dealing directly with patients.
Cheek added, “It’s important for us to not only get kits where they are needed most, but also to ensure that we can continue to be part of the solution here,” Cheek said. “We certainly don’t want to take an action that we don’t have clarity on yet.”
More from Statesman:
Cheek said Everlywell, which put up a $1 million incentive to fuel research into the new kit, only worked with labs that were developing tests that would comply with the FDA’s guidelines on emergency use authorization.
“We believe that the statement is strong enough to make us want to ensure that we are getting guidance from them on how to proceed with self-collection,” she said.
The FDA on Monday clarified on its website that its policies for emergency use authorization for coronavirus diagnostic tests do not apply to any that involve self-collection of samples.
“As noted in the guidance, the policies outlined in the policy for diagnostic tests for coronavirus disease-2019 do not apply to at-home testing, including self-collection of samples to be sent to a clinical laboratory,” the FDA stated on its website.
Everlywell said it was planning to offer kits, priced at $135 per kit, to those who qualified under guidelines provided by the Center for Disease Control and Prevention.
The test was designed to allow potential patients to self-administer a swab sample that could be sent into a lab that is certified to conduct human-sample testing under U.S. regulations surrounding laboratory standards.