| Oof, Rutgers miswrote the entire article. Flagged for being extremely misleading on Rutgers' part (OP only quoted them). This isn't an approval, it's an Emergency Use Authorization. They're completely different. https://www.fda.gov/emergency-preparedness-and-response/mcm-... An EUA is specifically to permit unapproved uses in exigent circumstances only. Approval still requires the full workup: https://www.fda.gov/news-events/approvals-fda-regulated-prod... --- @dang, is there value in changing the title from its current state ("FDA Grants Approval for First Saliva Based Coronavirus Test") to "FDA grants Emergency Use Authorization for Saliva Based Coronavirus Test"? --- Edit 2:33pm EDT: calling Rutgers to clarify. Edit 2:36pm EDT: the appropriate contact for the article has received my message and (as best as I know) is clarifying the release. Edit 3:01pm EDT: thanks for changing the title, dang! |
Per an AP article[1] on the confusion surrounding this issue:
> Companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected.
I see no language like that in the article. But lots of quotes implying efficacy of the test:
> we no longer have to put health care professionals at risk for infection
> we can preserve precious personal protective equipment
> we can significantly increase the number of people tested each and every day
Sadly, I think we are about to see more of this, as companies jump at the chance to get some PR and stock price bump.
[1] https://www.sltrib.com/news/2020/04/12/fears-wild-west-covid...