FDA Authorizes At-Home Coronavirus Test Collection Kit
The new kit will have association with multiple certified labs for diagnostics, and will come at no profit for the maker company.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to a coronavirus 2019 (COVID-19) at-home sample collection kit.
The kit, made by digital health company Everlywell, is the first to receive an EUA for at-home COVID-19 testing kit that is not associated with a specific laboratory—thereby allowing the company to provide different offerings of test samples to various certified labs for assessments.
The company intends to use at least 2 certified high-complexity partner laboratories to process their tests at launch, but intend to add more partners following the new authorization from the FDA. The test kits will be offered at no profit to Everlywell, with the $109 price covering its costs—including overnight shipping to the lab, processing fees, physician review and diagnosis, and components of the kit itself.
Patients will be able to submit a claim to their insurance company to seek reimbursement for the test’s costs through information provided by Everlywell, and costs of the test will be covered by participating FSA and HSA plans.
Frank Ong, MD, chief medical and scientific officer at Everlywell, expressed gratitude to the FDA for its “close partnership and guidance” in issuing the first authorization to a digital health company relevant to COVID-19 testing.
"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,” he said in a statement.
More widespread access to convenient testing will play a crucial role, Julia Cheek, chief executive officer and founder of Everlywell said, in the US’ ability to address the pandemic while preventing healthcare facility overburdening.
“As the national leader in connecting people with high-quality laboratory testing, we are committed to fighting the spread of this virus in America," Cheek said.