Everlywell, a health and wellness company that provides at-home lab testing kits, has received an Emergency Use Authorization (EUA) from the FDA for a COVID-19 at-home collection kit. Everlywell’s EUA is the first to be issued to a digital health company that is not a diagnostics manufacturer. It is also the only EUA for at-home COVID-19 testing that is not tied to one specific lab; the company is allowed to work with a number of certified labs, allowing for large-scale testing.
Each at-home kit provides a molecular PCR test, which detects the presence (or absence) of active SARS-CoV-2 virus (i.e. coronavirus) in a “self-collected nasal swab.”[1] The kit includes an online screening questionnaire, instructions on how to collect and ship a sample to the lab, digital results within 48 hours of the sample being received by the lab, and results reviewed by an independent physician. Positive test results include a follow-up “telehealth consult” and are reported to federal and local public health agencies.[2]
The kits are limited to one per household and cost $109 each. They are available now on Everlywell’s website: https://www.everlywell.com/products/covid-19-test/.
According to GoodRx, there are currently five companies selling at-home COVID-19 tests: Pixel by LabCorp, Everlywell, Vault, Vitagene, and him & hers.[3] These at-home tests appeal to the masses; they are quick and convenient, especially for individuals who may not want to get tested in person or cannot commute to in-person testing sites.
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[1] Everlywell. “COVID-19 Test Home Collection Kit,” https://www.everlywell.com/products/covid-19-test/.
[2] Id.
[3] GoodRx. “Can I Test for Coronavirus At Home? The State of At-Home COVID-19 Tests” (May 26, 2020), https://www.goodrx.com/blog/coronavirus-at-home-tests/.