Austin, Texas-based EverlyWell, a digital platform that lets consumers order lab tests online and view their results, has received an FDA Emergency Use Authorization (EUA) for a COVID-19 at-home diagnostic sample collection kit that can be used with multiple diagnostic lab tests.
Announced Friday by the FDA and Monday by the startup, the EverlyWell COVID-19 Test Home Collection Kit includes nasal swabs, a tube filled with saline and shipping instructions.
These samples are sent to a CLIA-certified lab equipped to run one of two in vitro diagnostic molecular tests that have been granted separate EUAs for use with EverlyWell's kit.
Results are returned to the patient through EverlyWell's digital platform within 48 hours of lab receipt and, if positive, will include a telehealth consult and appropriate case reporting.
"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," Julia Cheek, CEO and founder of EverlyWell, said in a statement. "As the national leader in connecting people with high-quality laboratory testing, we are committed to fighting the spread of this virus in America."
To receive the kit, consumers must complete a digital screening questionnaire that is reviewed by an EverlyWell provider. The kits and service will run customers $109, a figure that EverlyWell stressed in its announcement provides no profit to the company.
The announcement also notes that EverlyWell will provide the necessary information for customers to submit a reimbursement claim with their insurance, but that the test is not currently covered by certain policies.
"EverlyWell ... is working with Congress to find a legislative solution to limitations that prevent companies like EverlyWell, which provides access to testing, but is neither a medical provider [nor] a laboratory providing COVID-19 testing services, from being directly reimbursed by insurers," the company wrote in its announcement. "The company has also reached out to policymakers to explore funding possibilities for making the tests available for free."
WHY IT MATTERS
This authorization comes two months after EverlyWell announced the launch of an at-home sample-collection kit that it believed was permitted under an FDA policy that permits COVID-19 testing to certain labs prior to receipt of an EUA. EverlyWell and others rescinded these consumer offerings within a week after clarification from the agency that these guidances did not apply to at-home consumer products.
"We share the FDA’s concern regarding fraudulent tests and are working directly with the FDA to increase the availability of COVID-19 testing," the company said at the time.
It's clear that the testing startup continued to do just that, as the EUAs for EverlyWell's kit and the associated lab diagnostic tests were well publicized by the FDA. In particular, the agency highlighted the public health benefits of a flexible at-home sample collection kit.
“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “[Friday]’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”
THE LARGER TREND
It appears the floodgates are finally beginning to open for at-home COVID-19 sample collection. LabCorp's COVID-19 RT-PCR test was the first to receive the agency's blessing in mid-April, but last week saw at least two other consumer-facing telehealth brands announce the availability of testing kits for another recently authorized saliva test for the disease.