Coronavirus (COVID-19) Update: FDA Authorizes First Standa
SILVER SPRING, Md., May 16, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing. Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. Everlywell's kit 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 allows an individual to self-collect a nasal sample at home using Everlywell's authorized kit. 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 authorized under separate, individual EUAs. Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data are submitted in an EUA request that demonstrate the accuracy of each test when used with the Everlywell at-home 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," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Today'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."
Today's 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.
This announcement follows two recent EUAs for diagnostic tests that also use at-home specimen collection: one that uses a sample collected from the patient's nose with a nasal swab and transported in saline and another that permits testing of a saliva sample collected by the patient at home. Everlywell's EUA request leveraged data from studies supported by The Bill and Melinda Gates Foundation and UnitedHealth Group to demonstrate stability of specimens during shipping. The data from these studies are freely available to support other EUA requests, alleviating each test developer of the burden of recreating the same study.
The Everlywell home-collection kit is currently the only authorized COVID-19 at-home sample collection kit for use with multiple authorized COVID-19 diagnostic tests. The kit and associated tests are available by prescription only.
Today's 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 specimens collected with the Everlywell at-home collection kit. It is important to note that this is not a general authorization for at-home collection of patient samples using other collection kits, swabs, media, or tests, or for tests fully conducted at home.
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.
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SOURCE U.S. Food and Drug Administration