UPDATE: On May 16th, Everlywell received an Emergency Use Authorization (EUA) from the FDA for our COVID-19 Test Home Collection Kit for diagnosing COVID-19. The COVID-19 kit will be available later this month and will come with everything needed to safely self-collect a sample at home, ship it to a CLIA-certified lab, and receive results within 24-48 hours of receipt by the lab. You can sign up to receive updates about Everlywell kit availability here, as well as reference our Testing Resource page where we have compiled other updates on testing capacity in the U.S.
The EUA issued to Everlywell is the first to be granted to a digital health company like Everlywell. Since March 23, while working with the FDA to attain an EUA for at-home sample collection, Everlywell has been supplying qualifying organizations with COVID-19 test supplies for use in clinical settings. To date we have supplied 30,000 test kits to frontline workers and patients in need.
Published: March 18, 2020
We're announcing that an at-home collection kit with telehealth diagnosis for COVID-19 will be available to consumers starting Monday, March 23. The initial supply of 30,000 tests amounts to a significant increase in total COVID-19 tests that have been processed in the U.S. as of March 18, 2020. By working with multiple labs to scale infrastructure, Everlywell plans to have testing and diagnosis capacity for a quarter of a million people weekly.
Using its existing infrastructure and distribution for at-home lab testing, earlier this month Everlywell announced a $1 million dollar development incentive to any certified laboratories who fulfilled requirements set by the FDA and Everlywell to prioritize development of a COVID-19 diagnostic test. The positive response from the laboratory community enabled Everlywell to build the full testing and diagnosis experience for COVID-19 in a matter of days.
The test can be requested online by consumers experiencing COVID-19 symptoms. Samples can be collected at home, preventing further exposure for themselves and the public. The labs we use for COVID-19 testing are operating under the Emergency Use Authorization guidelines issued by the FDA.
Like Everlywell's other tests, the COVID-19 test will be shipped to customers with everything needed to collect a sample at home and safely ship that sample to a CLIA-certified laboratory. Samples will be shipped to labs with overnight delivery, secure digital results will be available online within 48 hours of the lab receiving the sample, and free telehealth consultations with an independent, board-certified physician will be available for those with positive results.
Availability, Pricing, and How It Works
To access a COVID-19 test, consumers can go to www.everlywell.com where they will be asked to complete a screening questionnaire, provided by our independent telehealth partner and based on guidelines from the Centers for Disease Control & Prevention (CDC). The test will be available for $135 at no profit to Everlywell, and will be covered by participating HSA and FSA providers. Everlywell has reached out to government officials and public health departments to see if the test can be made available for free. Given the high demand for testing, the company will work rapidly to make more tests available as the global supply shortage for COVID-19 diagnostic kits is addressed.
The testing experience includes:
- Overnight sample delivery (a shipping label is included).
- Infectious disease sample collection and shipping materials to safely ship your sample, using COVID-19 guidelines set by the CDC and the recommendations provided by the United Nations Committee of Experts on the Transport of Dangerous Goods (UN).
- Private, secure digital results provided to all users within days. (Everlywell is a HIPAA compliant company and we never sell customer data).
- Individuals with positive results will be offered a telehealth consult with an independent board-certified physician from PWNHealth.
- Positive results will be communicated to all mandated federal and state reporting agencies.
We are committed to doing everything we can to help stop the spread of coronavirus. Stay tuned here for more information.