At-Home Test for Coronavirus Granted Emergency FDA Approval
A newly-produced at-home coronavirus test kit has received emergency approval from the U.S. Food and Drug Administration on Saturday, according to an FDA press release. The tests will be available later this month, set at $109 each, according to the developer.
FDA grants emergency approval for at-home coronavirus test
The FDA granted emergency approval for an at-home sample collection kit used to test for coronavirus infection at specified laboratories designed for COVID-19 diagnostic tests, according to the press release.
The test kit — designed by Everlywell — is approved for individual use pending initial screening via an online questionnaire later reviewed by a health care provider and will be available later this month.
However, there is a limit of one test kit per household, and the test will not be available in Maryland, New Jersey, New York, or Rhode Island, according to Everlywell's website.
"The authorization of a COVID-19 at-home collection it 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. "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 to fight against this pandemic."
FDA-approved at-home test kit details and price
Everlywell's test kit includes nasal swabs along with a saline-solution-filled tube to store the swab, after which it is shipped to one of two private companies: Fulgent Therapeutics or Assurance Scientific Laboratories.
Both labs have received independent emergency authorization to process the coronavirus test from Everlywell.
"From the moment that you hit the order button, to the moment that you get the results on your phone or device, that process is designed to take three to five days," said Everlywell spokesperson Christina Song to The New York Times.
Song added that the test kits will be available for public use in late May, with a cost set at roughly $109 each, according to Everlywell.
Other coronavirus at-home test kits gain FDA approval
Additionally, the FDA also granted emergency authorization for two other at-home COVID-19 test kits. The first is LabCorp's nasal swab kit that was recently made widely available after an initial priority release to frontline healthcare workers.
The second one was a saliva sample kit from Rutgers Clinical Genomics Laboratory.
To reassure all interested parties that samples can survive shipping, Everlywell cited data from studies carried out via The Bill and Melinda Gates Foundation and UnitedHealth Group.
In a statement, the FDA said other companies were allowed to use the same data during emergency use requests — a possibility that might speed up the test kit approval process.
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