May 18, 2020
An at-home COVID-19 kit developed by Everlywell has been authorized by the U.S. Food and Drug Administration, the digital health company announced Monday.
This marks the first emergency use authorization the FDA has given to a company that isn't a laboratory or diagnostic manufacturer. Everlywell connects people and organizations with laboratory testing instead of solely working with a specific laboratory.
The collection kit uses a short nasal swab to test for the coronavirus. It also includes a digital screening questionnaire reviewed by a healthcare provider and instructions on how to safely ship the sample to the lab for testing.
Digital results will be available within 48 hours of the sample being received by the lab. All results are reviewed by an independent physician. Anyone who tests positive will receive a telehealth consult and the test results will be reported to the appropriate federal and local public health agencies.
"We appreciate the FDA's close partnership and guidance in issuing this authorization, which is the first EUA for a digital health company such as Everlywell," Dr. Frank Ong, chief medical and scientific officer at Everlywell, said in a statement. "Working with a growing number of authorized laboratories over time enables Everlywell to scale COVID-19 testing for Americans where they need it most – in their homes."
The at-home test kits will be available later this month.
Everlywell initially plans to use at least two CLIA-certified high-complexity partner laboratories to process tests. The labs have received FDA authorization for COVID-19 diagnostic tests that can be used with the samples collected using the Everlywell kit. The company intends to add more lab partners later.
Everlywell officials said the test kit will be offered at no profit to the company. The $109 price covers the costs, including overnight shipping and lab processing fees. Patients can submit a claim to their insurance company for reimbursement, but coverage will depend on an individual insurance plan.
The FDA also has authorized two other COVID-19 diagnostic tests that use at-home specimen collection.
One uses a sample collected from the patient's nose via a nasal swab and transported in saline. The other test, developed by Rutgers University, allows patients to take their own saliva sample and test it at home.
The FDA continues to be concerned about the proliferation of at-home COVID-19 testing that hasn't received proper vetting.