FDA grants emergency authorization for first saliva-based coronavirus test

One of the bigger issues with COVID testing is false negatives. I wonder how an even smaller sample of viral load will fare with that.

Ok, but:<p>1) how accurate is it?<p>2) how fast is it?<p>3) what equipment is needed to run it?<p>4) how robust is it to mis-handling?

As I understand it, the material supply chains for testing are limited in two key ways: The sample collection material (swabs), and the reagents that the tests need to function.<p>It sounds like this helps address the sample collection material supply chain, but how do we scale the reagent supply chain? The entire world desperately needs test capacity to increase by a factor of 10 or more, but is that actually possible?<p>Every single expert says mass testing is the only way to get ahead of this before a vaccine arrives, but I&#x27;m very worried that mass testing on the scale needed is simply impossible, which leaves us with only two choices - stay in lockdown for over a year waiting for the vaccine, or accept that herd immunity is the only way out, and do what we can to minimize the damage as the virus spreads, e.g. mandating masks in public, keeping the elderly population isolated while the rest of the population is gradually exposed,etc.

Perhaps silly to ask, but: why does the FDA regulate this?<p>It’s not a food, it’s not a drug, if it’s purely a saliva swab it is non-invasive — so where does the FDA come in?<p>In a university context, there is often a blanket IRB exemption for certain kinds of research where the risks are self-evidently minimal, such as taste tests.<p>If the FDA’s role here is to provide a stamp of approval indicating “this test ‘works’ according to an accepted standard,” then I would think something closer to how food supplements are monitored would be a better fit, for example, the test could come with text saying “this language has NOT been approved by the FDA” or equivalent for approval.<p>I am failing to see risks here besides the risks of misdiagnosis, but I just didn’t think it was the FDA’s mandate to approve or not approve based on efficacy.

Anyone know what mechanism this test uses? I didn&#x27;t see it in a skim of the article.<p>Saying this because viral load seems to be peaking in the upper respiratory on _day one_ of symptoms, and quickly decreasing from there as it moves to the lungs.<p>But maybe if this is an antibody test, that won&#x27;t matter?

Does this mean the fda actually tested it or is it just the official stamp of not being banned (yet)?

Sensitivity and specificity rate of this test?

Will this be an antibody test?

Oof, Rutgers miswrote the entire article. Flagged for being extremely misleading on Rutgers&#x27; part (OP only quoted them).<p>This isn&#x27;t an approval, it&#x27;s an Emergency Use Authorization. They&#x27;re completely different. <a href="https:&#x2F;&#x2F;www.fda.gov&#x2F;emergency-preparedness-and-response&#x2F;mcm-legal-regulatory-and-policy-framework&#x2F;emergency-use-authorization" rel="nofollow">https:&#x2F;&#x2F;www.fda.gov&#x2F;emergency-preparedness-and-response&#x2F;mcm-...</a><p>An EUA is specifically to permit unapproved uses <i>in exigent circumstances only.</i> Approval still requires the full workup: <a href="https:&#x2F;&#x2F;www.fda.gov&#x2F;news-events&#x2F;approvals-fda-regulated-products&#x2F;about-fda-product-approval" rel="nofollow">https:&#x2F;&#x2F;www.fda.gov&#x2F;news-events&#x2F;approvals-fda-regulated-prod...</a><p>---<p>@dang, is there value in changing the title from its current state (&quot;FDA Grants Approval for First Saliva Based Coronavirus Test&quot;) to &quot;FDA grants Emergency Use Authorization for Saliva Based Coronavirus Test&quot;?<p>---<p>Edit 2:33pm EDT: calling Rutgers to clarify.<p>Edit 2:36pm EDT: the appropriate contact for the article has received my message and (as best as I know) is clarifying the release.<p>Edit 3:01pm EDT: thanks for changing the title, dang!

Any of these companies involved have tickers ?