eMed Announces Over-the-Counter Approval for Abbott's Rapid At-Home Testing with Verified Results

 

MIAMI, April 2, 2021 /PRNewswire/ -- eMed™, the architect behind the first BinaxNOW™ at-home COVID-19 test kit, announces the non-prescription home use availability of third-party guided and verified COVID-19 at-home tests for asymptomatic serial testing and screening, with results accepted by many airlines and businesses using the Abbott BinaxNOW™ home test and eMed telehealth services.

"I want to congratulate and thank Robert Ford, Abbott CEO, for believing in and forging ahead on this important mission to help democratize healthcare," said eMed Co-Founder and CEO, Dr. Patrice Harris. "eMed's third-party verification technology platform was instrumental in reconfiguring Abbott's professional-use BinaxNOW test for at-home use, resulting in Abbott receiving its first FDA EUA approval for at-home testing in December 2020. I'm so proud of how far we have come in bringing affordable test solutions to all Americans, including vulnerable populations."

Since receiving EUA approval, eMed, in partnership with Abbott, has distributed and administered millions of tests to states, nonprofit organizations, schools, businesses and individuals across the country.

eMed is actively working with other test manufacturers applying its eMed technology to home-enable third-party verified results for other diagnostic tests such as influenza, drug testing and sexually transmitted infections, among other conditions.

eMed tests are always virtually guided by an eMed Certified Guide, who monitors the test and provides third-party validation of the result. eMed reports results to the appropriate public health authorities, providing critical data for population health management.

About eMed

eMed (www.eMed.com) is a digital-point-of-care health company democratizing healthcare with a digital platform that provides fast, easy and affordable at-home healthcare testing, supervised and guided online by eMed Certified Guides. We embrace quantitative medicine to deliver prescribed tests and treatments directly to patients, driving better and more cost-effective health outcomes.

  • This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;
  • This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and,
  • This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

 

 

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SOURCE eMed

 

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