MedTechFDA Authorizes Everlywell's Home Collection Kit For Use With Multiple COVID-19 Tests

The FDA authorized a new at-home collection kit that allows people to take their own nasal swab samples and then mail them overnight to a laboratory to be tested with different authorized coronavirus diagnostics.



“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. 


Developed by the home health testing company Everlywell, the company’s emergency authorization request was supported by data from studies from The Bill & Melinda Gates Foundation and UnitedHealth Group showing self-collected specimens could remain stable through the mail.


The agency said the data from those studies are freely available and can be used by developers of other home-based coronavirus tests, enabling them to request their own FDA authorization without recreating the work.


“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,” Shuren said.  


Everlywell’s prescription-only kit—consisting of a nasal swab and a saline-filled transport tube—was authorized for use with two specific coronavirus tests developed by Fulgent Therapeutics and Assurance Scientific Laboratories and requires the user to first fill out an online questionnaire that is reviewed by a healthcare provider. 


The FDA said additional tests may be permitted to use Everlywell’s self-collection kit in the future.


In the past few weeks, the agency issued emergency authorizations for LabCorp’s at-home collection kit and a saliva-based test developed by Rutgers University. 


Prior to that, the FDA clamped down on home-based COVID-19 tests in late March, just days after Everlywell and a number of other telehealth and online testing companies announced plans to pivot toward coronavirus testing through the mail. At the same time, federal government agencies had begun to intercept packages of fraudulent COVID-19 test kits being shipped to the U.S. from overseas.


Read More Here



0 views
Subscribe for News and Insights

© 2020 All Rights Reserved. Katan Associates International.

  • LinkedIn - Grey Circle
  • Twitter - Grey Circle
  • Facebook - Grey Circle