Last updated: 3/23/20
There is an extreme shortage of tests for COVID-19 in America today. Everyone from the White House to the CDC and the medical community have called for an increase in safe, accurate, affordable testing using a variety of solutions—a call which reflects the reasons why Everlywell was founded five years ago. As the situation around lab testing supply and capacity in America grew increasingly dire, the company decided to use its resources and expertise to help in the fight against COVID-19.
On February 29, the FDA issued a new policy designed to expedite the availability of diagnostic tests for COVID-19 to address the testing shortfall in America. In response, Everlywell issued a call to work with CLIA-certified laboratories across the nation to fast-track development of a diagnostic, at-home collection test for COVID-19. In order to work with Everlywell to bring COVID-19 testing to Americans, these labs had to meet all requirements set by the FDA in addition to Everlywell’s own set of requirements around laboratory testing quality.
Dozens of laboratories applied, which we narrowed down to a short list of less than ten high-quality, CLIA-certified labs—many of which already offered infectious disease assays, including tests for other respiratory viruses besides SARS-CoV-2 coronavirus/COVID-19. Many of these labs were already conducting diagnostic COVID-19 tests for hospitals and clinics in their regions as well. We worked with each laboratory to ensure they were all operating under the Emergency Use Authorization guidelines issued by the FDA, including the updated guidance published on March 16.
On Wednesday March 18, Everlywell announced that it had 30,000 at-home collection kits for COVID-19 that would be available to the public on March 23. We estimated that within months, our partner labs would have the ability to test a quarter of a million people each week for COVID-19. Response from the public was immediate: we received countless notes, emails, calls, and letters from Americans about the test. Most were thankful; many were relieved for their family and friends. Many had questions about cost (answer: the price of our test covered some of our costs and we were working to make it free) and availability (available only to those who met CDC guidelines for testing). Some simply said “Thank you.” Others said more. An overwhelming number of these notes were from healthcare professionals. In fact, in the days following our announcement, we received thousands of notes from physicians, nurses, and healthcare workers on the front lines asking Everlywell for access to these tests—both for their highest risk patients and for themselves.
On Friday evening, the FDA issued an update with information about fraudulent at-home tests for COVID-19, of which there have been multiple reports, and a statement about at-home collection tests for COVID-19, the type of test Everlywell offers: “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 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 is working directly with the FDA to understand these comments and any potential new guidance around at-home collection for COVID-19 testing.
Separately, on Saturday afternoon, the White House’s Coronavirus Task Force identified a list of groups that should receive priority access to COVID-19 testing, including healthcare workers on the front lines, symptomatic individuals in long-term care facilities, and symptomatic individuals over 65 years of age.
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. 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, which we announced on Sunday. 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 test will be administered by healthcare providers.
We are still committed to making a COVID-19 test available to consumers who fall within the CDC’s guidelines for recommended testing and are actively working with the FDA on a path forward for COVID-19 sample self-collection in a home setting. We will be providing updates about consumer availability on our site. If you represent a hospital, healthcare company, or medical facility who needs COVID-19 sample collection kits, please contact us here. If you are an individual who needs COVID-19 testing, you can access additional resources here.
The company issued this statement today:
Everlywell is a national leader in connecting individuals with high-quality laboratory testing. 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 COVID-19 test developed by Everlywell’s lab partners is an rt-PCR-focused test following the CDC-recommended testing methodology already being used for the majority of diagnostic COVID-19 testing today. The test was developed by its partner laboratories while operating under the Emergency Use Authorization guidelines issued by the FDA. Our COVID-19 partner labs are CLIA-certified labs—many of which already offered infectious disease assays, including tests for other respiratory viruses besides SARS-CoV-2 coronavirus/COVID-19. Many of these labs also already conduct diagnostic COVID-19 tests for hospitals and clinics in their regions.