FDA advisory leads Austin’s Everlywell to hit pause on direct-to-consumer coronavirus testing kits – Business – Austin American-StatesmanMarch 24, 2020
Austin-based medical diagnostics company Everlywell says it has hit the pause button on plans to release its first batch of testing kits for the COVID-19 coronavirus directly to consumers.
The company announced last week that it would start selling the testing kits directly to consumers starting Monday. However, on Sunday the company changed course and said the first batch of 30,000 kits would now only be offered to facilities with medical staff who are dealing directly with patients.
“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,” the company said on its website.
Everlywell CEO Julia Cheek said the company had been under the impression that its new kits would not be in conflict with U.S. Food and Drug Administration regulations. But on Friday — after Everlywell had already announced its plans — the FDA published a statement clarifying its stance on testing kits that can be self-administered.
“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.”
The FDA has said that it would consider emergency use authorization, an expedited process for clearing products for public use, for proposals involving diagnostic devices for the coronavirus.
According to the FDA website, the agency does “not intend to object to the use of validated tests for specimen testing for a reasonable period of time after validation while the laboratory is preparing an EUA request.”
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.
Following the FDA’s Friday statements, Cheek said the company is waiting for further directions from the agency regarding self-collection.
“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…