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FDA grants emergency authorization for at-home COVID-19 tests
The U.S. FDA has granted an emergency use authorization to Everlywell Inc., to conduct and collect at-home testing for COVID-19.
With the ever-increasing need for more comprehensive testing during the current coronavirus pandemic, the United States Food and Drug administration (FDA) has made the decision to grant emergency use authorization (EUA) for COVID-19 at-home sample collection testing kits.
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Everlywell Inc., the agency granted the EUA, will distribute the kits to individuals who complete an online COVID-19 questionnaire that is evaluated by a healthcare provider. Patients then provide a nasal sample and ship it overnight to Fulgent Therapeutics or Assurance Scientific Laboratories who will run an in vitro diagnostic molecular test to determine if the virus is present.1
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“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,” says 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.”2
More information about the at-home testing kits can be found at www.medicaleconomics.com.
References:
1. Reynolds, K. A. (2020, May 18). Coronavirus: FDA authorizes at-home sample collection kit. Retrieved May 21, 2020, from https://www.medicaleconomics.com/news/coronavirus-fda-authorizes-home-sample-collection-kit
2. Commissioner, O. (2020, May 16). Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests. Retrieved May 21, 2020, from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-standalone-home-sample-collection-kit-can-be-used
