AUSTIN (KXAN) — Members of the U.S. House Subcommittee on Economic and Consumer Policy sent a letter to Austin-based digital health company Everlywell asking for answers about the company’s at home COVID-19 test kits.
Last week, Everlywell announced it planned to launch at-home COVID-19 test kits for consumer purchase on Monday, but the company announced it was changing course on Sunday, March 22 to supply its initial batch of tests only to hospitals and health providers. Everlywell explained that it is not a lab nor a manufacturer, rather the company “connects consumers with laboratory testing conducted by CLIA-certified labs.”
It is important to note that the FDA recently alerted consumers that at this time it has not authorized any tests for consumer purchase that would allow at-home testing for COVID-19.
Everlywell said in an email to KXAN Wednesday that it hopes to make its consumer COVID-19 test available soon and will be providing updates on the availability of that test on its website. If you look at Everlywell’s website currently and specify you are an individual looking for a consumer test, you are informed that at-home COVID-19 tests are not available for individual purchase yet. But details on the site show that when they are made available to consumers, they will cost $135 per test and only one purchase will be available per household due to global manufacturing constraints.
In a release Wednesday, House Subcommittee on Economic and Consumer Policy Chairman Rep. Raja Krishnamoorthi (D-Illinois) was joined by committee member Rep. Katie Porter (D- California) in announcing they had written letters to three companies asking for information about each company’s at home-test kits. This subcommittee is part of the House Committee on Oversight and Reform.
In a letter to Everlywell, the representatives note that the FDA cautioned in the past few days against using at-home testing kits and that the FDA has “has not authorized any test that is available for purchase for testing yourself at home for COVID-19.”
The representatives ask Everlywell a series of questions, including: when their company started offering at-home coronavirus test kits for sale, when they stopped selling those test kits, how many at-home coronavirus test kits did their company sell, how much did they charge, how many consumers returned test kits with their samples, whether they intend to refund all consumers all amounts they paid for at-home coronavirus test kits and when and how they will do so, how many nasopharyngeal swabs does Everlywell possess and will they donate them for use with FDA approved coronavirus tests, and whether they intend to destroy all consumer samples received.
Everlywell is asked to respond to this subcommittee by March 27.
A Tweet from the Congressional Oversight Committee Wednesday had even stronger language, saying the subcommittee members “want answers” from the three companies who they claim “rushed to market their at-home #Coronavirus test kits w/out @US_FDA authorization.”
Everlywell’s Twitter account replied to this, emphasizing that despite earlier plans to launch at-home testing for consumers, that they had not in fact given any at-home tests to consumers.
Everlywell tweeted: “On March 18, we announced that we would soon be launching an at-home collection solution for COVID-19 testing, partnering with labs operating under the FDA’s EUA guidance & priced at no profit to us.”
Everlywell continued: “Following the FDA’s statement on March 20 regarding sample collection in a home setting for COVID-19 testing and the White House’s appeal to increase testing available to healthcare organizations, Everlywell has distributed test materials solely to healthcare facilities and providers on the frontlines. We are providing these tests at cost to hospitals and healthcare organizations who can commit to providing the test for free to their workers and patients. “
Lastly, Everlywell tweeted: “We have not provided any collection kits to consumers and are actively working with the FDA on a path forward for COVID-19 sample self-collection in a home setting. “
In a reply to another tweet, Everlywell’s account said the lab partners they worked with to create the COVID-19 test are operating under the Emergency Use Authorization guidelines issued by the FDA. Everlywell added that it is currently working with hospitals and healthcare companies where the test will be administered by healthcare providers.
In an email to KXAN on Wednesday, an Everlywell spokesperson explained that the company is actively distributing its COVID-19 tests to hospitals and healthcare systems throughout the country right now. In fact, the spokesperson said that Everlywell is on track to deliver thousands of kits this week.
“We are prioritizing areas with community spread and a significant shortfall of tests,” said spokesperson Christina Song in the email. She added that one of the healthcare facilities where Everlywell will be delivering tests is in Austin.
Song also noted that the company is actively working with the FDA “on a path forward for COVID-19 sample self-collection in a home setting. “
While neither Everlywell’s email response to KXAN on Sunday nor the blog they posted that day noted the FDA’s March 20 direction that the administration has not authorized any at-home test kit for COVID-19 yet, Song acknowledged that the FDA direction played a role in Everlywell’s decision to pivot away from at-home COVID-19 tests for consumers.
“Following the FDA’s statement on March 20 regarding sample collection in a home setting for COVID-19 testing and the White House’s appeal to increase testing available to healthcare organizations, Everlywell has distributed test materials solely to healthcare facilities and providers on the frontlines,” she said.
In an email to KXAN on Tuesday, a spokesperson for Everlywell explained that its tests will be available for purchase to qualifying hospitals, clinics, nursing homes and assisted living facilities “who can commit to distributing the test for free to their doctors, nurses, staff, and symptomatic patients affected by the testing shortages.”
Everlywell, who sells at-home test kits for other conditions, reiterated that it would not be making a profit off of these COVID-19 tests.
When asked if their tests were FDA approved, the Everlywell spokesperson responded saying: “we share the FDA’s concern regarding fraudulent tests and are working directly with the FDA to increase the availability of COVID-19 testing. During this process, we will continue to provide urgently needed tests to qualifying hospitals, healthcare 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.”
The spokesperson added that their partner labs are CLIA certified labs, many of which offer tests for other respiratory viruses and many of which already conduct diagnostic COVID-19 tests for healthcare providers.
In an online statement, Everlywell said that it worked with each laboratory it has partnered with on the COVID-19 test to make sure they were following the Emergency Use Authorization guidelines issued by the FDA.
Why the hold up on at-home test kits?
The FDA issued an alert to consumers on March 20, explaining that at the present moment, the FDA has not approved any companies to do at-home COVID-19 testing.
The administration released a statement saying that the U.S. Food and Drug Administration is “actively and aggressively monitoring” for any companies marketing products with fraudulent coronavirus (COVID-19) diagnosis, prevention, or treatment claims. The FDA says they are beginning to see “unauthorized fraudulent test kits” being marketed for at-home COVID-19 testing.
“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 emphasized.
But this doesn’t mean that at-home COVID-19 test kits are totally off the table, the administration noted it sees the value of expanding safe and accurate testing to include things like at-home sample collection. The FDA also said they are actively working with test developers in that space.
KXAN asked the FDA if it was working with Everlywell to develop an at-home sample collection. An FDA press officer said in an email that the administration “generally cannot discuss information for specific companies.”
Everlywell said that all of its laboratory partners conducting COVID-19 testing “have had their validation data and reports reviewed by the FDA under the Emergency Use Authorization (EUA) framework.”
Correction: A previous version of this story noted FDA lists of EUA labs and manufacturers. Everlywell is neither a lab nor a manufacturer.