After its earlier effort was tripped up, Austin-based startup Everlywell on May 16 finally gained approval from the U.S. Food and Drug Administration to launch its at-home coronavirus test.
In a May 16 release, Everlywell says the self-administered test will be available later this month. The company, which specializes in at-home tests for an array of conditions, is the first to receive approval from the FDA for an at-home coronavirus test that’s not associated with a lab or a manufacturer of diagnostic products.
The FDA’s emergency authorization allows Everlywell to work with a number of certified labs that process authorized tests, rather than just a single lab.
“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, says in a release.
Everlywell’s at-home test determines the presence or absence of the novel coronavirus, which causes COVID-19 illness. Everlywell’s test kit uses a short nasal swab and includes:
- A digital screening questionnaire reviewed by a healthcare provider.
- Instructions on how to ship the test sample to a lab.
- Digital results within 48 hours of the sample being received by the lab.
- Results reviewed by an independent physician.
Anyone who tests positive test will receive a telehealth consultation. All positive test results are reported to federal and local public health agencies when mandated.
On March 23, Everlywell was supposed to start shipping 30,000 coronavirus test kits to U.S. consumers. But before a single test was sent, the FDA blocked distribution of at-home, self-administered tests from Everlywell and other companies. After that, Everlywell pivoted to supplying coronavirus tests to healthcare providers and organizations.
As with the company’s previously approved coronavirus test, Everlywell says its test for individuals is sold at no profit. The $109 price covers costs such as overnight shipping to a lab, lab-processing fees, and kit components. Some health insurers cover coronavirus tests.
Everlywell says it’s working with members of Congress to enable companies that are neither healthcare providers nor labs to be directly reimbursed by health insurers. The startup also is exploring how its coronavirus test could be made available for free.
“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. As the national leader in connecting people with high-quality laboratory testing, we are committed to fighting the spread of this virus in America,” Julia Cheek, founder and CEO of Everlywell, says in the Everlywell release.
The company continues to supply its coronavirus tests to qualified healthcare organizations and government agencies.