4,246,543 words. 4,953 posts.

An At-Home Coronavirus Test Just Got Emergency FDA Approval. Here’s What We Know

by | May 18, 2020 | New, News

If you genuinely want something, don’t wait for it – – teach yourself to be impatient.

— Gurbaksh Chahal

(Rodolfo Parulan Jr./Getty Images) HEALTH An At-Home Coronavirus Test Just Got Emergency FDA Approval. Here's What We Know author logo MORGAN MCFALL-JOHNSEN, BUSINESS INSIDER 18 MAY 2020

A new at-home coronavirus test kit just got emergency approval from the US Food and Drug Administration.

The sample collection kit, from home testing company Everlywell, will be available by prescription only. An online questionnaire reviewed by a healthcare provider will screen potential patients.

The kit includes nasal swabs for taking a sample along with a saline solution-filled tube to store the swab and ship the sample to one of two private companies: Fulgent Therapeutics or Assurance Scientific Laboratories.

Those labs have their own emergency authorization to process Everlywell's coronavirus tests.

"From the moment that you hit the order button, to the moment that you get the test results on your phone or device, that process is designed to take three to five days," Everlywell spokesperson Christina Song told the New York Times.

Song said that the test kits will be available in late May for US$135 each.

The FDA has given emergency authorization to two other at-home COVID-19 testing kits. The first was LabCorp's nasal swab kit, which the company recently made widely available after prioritising frontline healthcare workers during its rollout.

The second was a saliva sample kit from Rutgers Clinical Genomics Laboratory.

To show that samples could survive shipping, Everlywell used data from studies by The Bill and Melinda Gates Foundation and UnitedHealth Group. In a statement, the FDA noted that other companies could use the same data in their emergency use requests. That could speed up the process for future test kit approvals.

"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," Jeffrey Shuren, director of the FDA's Centre for Devices and Radiological Health, said in the statement.

"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."

This article was originally published by Business Insider.

More from Business Insider:

  • Fed Chairman Jerome Powell warns that economic downturn could last until late 2021
  • 10 things in tech you need to know today
  • Latest fintech industry trends, technologies and research from our ecosystem report
  • As Australian and US states lift lockdowns, one expert says 4 key differences helped Australia manage its outbreak while the US is fumbling its response
  • Fired scientist Rick Bright says the US coronavirus response has been 'chaotic' and lacks a clear strategy

View Original Article

Site VisitorsMap

foolery, n.

foolery, n. An instance of foolish behaviour; a foolish or ridiculous belief, action, or thing.

Recent News

Site Statistics

301 registered users
4,246,543 words
4,953 posts, 2 comments
9243 images