The U.S. Food and Drug Administration approved Everlywell Inc.’s at-home sample collection kit for COVID-19 diagnostic testing.
“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, director of the FDA’s Center for Devices and Radiological Health.
The Test kits will be available for individual purchase by the end of the month, the company said.
The FDA issued an emergency use authorization to Everlywell COVID-19 Test Home Collection Kit that can then be sent to specified laboratories for COVID-19 diagnostic testing.
The 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. The authorization allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit, the FDA said in a statement.
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.
The at-home test will use a nasal sample to test for the OVID-19. Once the samples are collected, they will be shipped to a certified lab and patients will receive their results online.
Meanwhile, the Bill and Melinda Gates Foundation’s Seattle Coronavirus Assessment Network or SCAN said that it suspended testing of home-based, self-collected samples for COVID-19.
SCAN said that the Washington State Department of Health authorized the test. However, the Food & Drug Administration recently clarified its guidance for home-based, self-collected samples to test for COVID-19.
SCAN said it has been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests. The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but SCAN has been asked to pause testing until it receive that additional authorization.
SCAN noted that it is working to address FDA’s questions and resume testing as soon as possible.
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