December 5, 2020

FDA Issues EUA for First COVID-19 Standalone At-Home Sample Collection Kit

The FDA has issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. Everlywell’s kit, a self-collected nasal swab, is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This marks the first standalone sample collection kit to be granted a proper EUA by the FDA. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit. These tests have been approved under separate, individual EUAs.

According to the press release, this kit is the only EUA for at-home collection COVID-19 testing that is not tied to one specific lab and allows the company to work with several certified labs offering several authorized tests, rather than being limited to a single laboratory or a single test. Everlywell will make no profit from the test and is priced at $109. This will cover its costs, such as overnight shipping to the lab, lab processing fees, physician review and diagnosis, and kit components.

Testing Process

The EUA for the Everlywell COVID-19 Test Home Collection Kit permits testing of a sample collected from inside the patient’s nose using the authorized self-collection kit that contains nasal swabs to collect a sample and a tube filled with saline to transport the sample back to a specified lab. Once patients self-swab to collect their nasal sample, they will ship the sample overnight to a specific CLIA-certified lab that is running one of the in vitro diagnostic molecular tests authorized under a separate EUA for use with the Everlywell at-home sample collection kit. The labs authorized to test specimens collected using the Everlywell at-home collection kit are Fulgent Therapeutics and Assurance Scientific Laboratories.  Results will be returned to the patient through Everlywell’s independent physician network and their online portal.

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.     Jeffrey Shuren, M.D., J.D., Director of the FDA Center for Devices and Radiological Health

All results are reviewed by an independent physician and will be available within 48 hours of the sample being received by the lab. If a patient tests positive, they will receive a telehealth consult, and the test results will be reported to the appropriate federal and local public health agencies. The authorization is limited to the Everlywell COVID-19 test for at-home collection of nasal swab specimens for analysis by COVID-19 diagnostic tests specifically authorized under separate EUAs for use with samples collected with the Everlywell at-home collection kit. Everlywell tests are currently available to residents in 47 U.S. states. Due to each state having different medical regulations, tests are not available to residents of New York, New Jersey, and Rhode Island.

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.

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, CEO and Founder of Everlywell

 

About Everlywell

Everlywell is a digital health and wellness company that provides at-home lab testing kits and digital results within just days. Everlywell connects consumers to laboratory testing and offers a suite of validated tests, including food sensitivity, fertility, STDs, and thyroid. Founded in 2015 by CEO Julia Cheek, the company was featured on ABC’s “Shark Tank” and is based in Austin, TX.

About FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Logan Harper

With an M.S. in Organizational Leadership, my background lies within the healthcare operations and sales sector, specifically within the digital health/ digital therapeutics arena. I have a proven track record of developing and implementing effective sales strategies, establishing organizational partnerships, and creating effective product/service/sales training programs and collateral.

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