FDA Authorizes First COVID-19 At-Home Sample Collection Kit Authorized For Use With Multiple Tests

Diagnostic testing for SARS-CoV-2 is a key tool in the combat against the COVID-19 pandemic. Since the Secretary of Health and Human Services declared a public emergency on January 31, 2020, calling for the entire country to aid in response to the COVID-19 outbreak, the U.S. has had low diagnostic testing rates due to a lack of testing capabilities.

In order to improve access to testing, the U.S. Food and Drug Administration (FDA) recently granted an emergency use authorization to Everlywell, Inc. for an at-home collection kit, allowing patients to self-collect a nasal sample and send it to specified laboratories for COVID-19 testing. 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. The FDA has authorized two SARS-CoV-2 diagnostic tests for use with the collection kit, which are conducted at approved laboratories, Fulgent Therapeutics or Assurance Scientific Laboratories. Testing results are returned to patients through Everlywell’s independent physician network and their online portal. The FDA indicates that it may expand testing options available to patients provided that future testing is shown to be accurate when used with Everlywell’s 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,” stated Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health.

The FDA previously granted two emergency use authorizations for diagnostic tests that give the option of using samples collected at home but were limited to single proprietary tests. Laboratory Corporation of America’s (LabCorp) at-home collection kit required patients to send a nasal swab to a LabCorp lab for testing. Rutgers Clinical Genomics Laboratory’s at-home kit permits testing of a saliva sample collected from the patient. Once patients collect their saliva sample, they return it to the Rutgers Clinical Genomics Laboratory for testing. Both tests remain prescription only.

All such at-home testing is important because it protects patients from visiting urgent care centers, primary care offices, hospitals and other clinical sites where a contagious person might spread the virus to others. It is speculative to predict when the FDA will approve additional at-home testing kits given the rapidly evolving pandemic, but more and more pharmaceutical and biologic companies are moving into this space given the public health need.



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