FDA has issued an emergency use authorization (EUA) for a home-use covid-19 specimen collection kit from Everlywell, Austin, Texas. Everlywell is a digital health company that connects people and organizations with laboratory testing resources, but is not itself a laboratory or diagnostics manufacturer.
The agency’s EUA for the home-use covid-19 specimen collection kit is not tied to one specific lab or test. Instead, the authorization permits Everlywell to work with a number of certified labs offering several authorized tests.
“We appreciate FDA’s close partnership and guidance in issuing this authorization,” says Frank Ong, PhD, chief medical and scientific officer at Everlywell. “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.”
FDA’s authorization permits individuals to obtain a molecular polymerase chain reaction test designed to detect the presence of SARS-CoV-2, the virus that causes covid-19, through one of Everlywell’s laboratory partners performing FDA-authorized covid-19 testing. At launch, the company will use at least two CLIA-certified high-complexity partner laboratories to process tests. More laboratory partners will be added as they receive FDA authorization for tests using Everlywell’s home-use specimen collection kit.
The kit includes collection components, a digital screening questionnaire reviewed by a healthcare provider, instructions on how individuals can safely ship their samples 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 will include a telehealth consultation and will be reported to the mandated federal and local public health agencies. The price of the kit covers kit components, overnight shipping to the lab, lab processing fees, and physician review and diagnosis.
Although Everlywell provides patients with the information necessary to submit a claim for reimbursement of the cost of the test, coverage will depend on individuals’ insurance policies. The cost of the test will be covered by participating flexible savings account (FSA) and health savings account (has) plans.
“Widespread access to convenient testing will play a crucial role in the country’s ability to address the pandemic and prevent overburdening our healthcare facilities,” says Julia Cheek, founder and chief executive officer of Everlywell. “As the national leader in connecting people with high-quality laboratory testing, we are committed to fighting the spread of this virus in America.”
For more information, visit Everlywell