
FDA grants emergency authorization for first saliva-based coronavirus test - new_time
https://www.rutgers.edu/news/new-rutgers-saliva-test-coronavirus-gets-fda-approval
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selectodude
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.

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fspeech
High false negatives due to low viral load in samples would be problematic for
diagnosis and treatment (except there is no specific treatment) but for public
health purpose it is just as important to test for infectiousness. Imagine if
we have a quick and easy way to self test saliva with high false negative rate
due to viral load in the saliva, we can feel more confident about not
infecting others through talking even if we can't be sure we are disease free.

~~~
_wldu
Roughly 1/3 covid tests are falsely negative[1]. I'm not sure any have been
cleared/approved by the FDA yet, but some are authorized for emergency use due
to the circumstances.

 _" Testing was performed using the cobas(R) SARS-CoV-2 test. This test was
developed and its performance characteristics determined by LabCorp
Laboratories. This test has not been FDA cleared or approved. This test has
been authorized by FDA under an Emergency Use Authorization (EUA). This test
is only authorized for the duration of time the declaration that circumstances
exist justifying the authorization of the emergency use of in vitro diagnostic
tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection
under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner."_

[1] - [https://www.wsj.com/articles/questions-about-accuracy-of-
cor...](https://www.wsj.com/articles/questions-about-accuracy-of-coronavirus-
tests-sow-worry-11585836001?mod=e2tw)

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KaiserPro
Ok, but:

1) how accurate is it?

2) how fast is it?

3) what equipment is needed to run it?

4) how robust is it to mis-handling?

~~~
credit_guy
1) Presumably quite accurate considering that they received the FRA approval

2) Not clear for this one, but FDA authorized another lab to do saliva-based
tests 10 days ago [1], and that test takes 24 hours.

3) It appears this test will be performed in the labs of a partnering health
network, RWJBarnabas, and not for a wider distribution (from the article).
Their goal is to get to tens of thousands of tests per day. They cover the New
Jersey area. My guess is that you take the saliva sample, send it to one of
their labs, and you get the answer in 24 hours.

4) Again, sufficiently robust so the FDA grants them the approval.

[1] [https://hitconsultant.net/2020/04/03/fda-24-hour-saliva-
test...](https://hitconsultant.net/2020/04/03/fda-24-hour-saliva-test-
covid-19/#.XpTGupp7mEI)

~~~
Atlas
This test has not been FDA approved and only has an Emergency Use
Authorization which does not test the efficacy as an FDA approval would. Even
the linked article says "this test has not been FDA cleared or approved."

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crystalmeph
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.

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?

Every single expert says mass testing is the only way to get ahead of this
before a vaccine arrives, but I'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.

~~~
alexbanks
I am fairly confident your option A is absolutely not an option.

~~~
crystalmeph
Yup. Year+ lockdown is not possible without reverting to a truly authoritarian
government model.

So ..., if widespread testing is not available, we don't have a choice, and
have to manage the flow of bodies as we reopen society in stages.

~~~
alexbanks
As I understand it, the goal of "flattening the curve" was never to reduce the
overall number of people that contract the virus. Which, to me, means that
neither herd immunity nor hiding were ever really the plan for covid. Giving
manufacturers the time to shift into overproducing PPE and researchers the
time to develop/test short term treatments so the hospitals could shift into
treating it as a part of routine coverage. I don't think you need herd
immunity to be prepared.

I can't tell if that's what you meant by "manage the flow of bodies." As I
understand it, lots of the deaths have been a result of timing and lack of
preparedness, not necessarily overall lethality of the virus itself.

~~~
kevin_b_er
The virus has a reported 12-20% hospitalization rate. Once they overfill in
any given region, the death rate and the hospitalization rate become the same.

We can argue about small percents for CFR, which only apply given healthcare
resources, but if we do not stay under the hospital thresholds by some means,
we get a catastrophic death rate that is comparable to the 1918 Spanish Flu,
which had something in the neighborhood of a 10-20% fatality rate.

Unless we somehow find an astonishing number of people are true asymptomatic,
this will hold. The Iceland survey does not yet count, as they surveyed and
tested and found a goodly number of people positive, but we haven't seen the
followup of how many develop symptoms where it can take 11.5 days in 97.5% of
all cases to develop.

So, we are in a Class 5 pandemic, one of similar severity to the 1918 Spanish
Flu. We just have oxygen and ventilators now for pneumonia. Once we run out of
those resources, we get to "manage the flow of bodies". If we get the
infection rate of the 2009 swine flu at 60.8 million cases, we stand to lose
up to 7 million lives in the United States alone.

~~~
alexbanks
I would challenge most of your numbers but I understand your sentiment.

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setgree
Perhaps silly to ask, but: why does the FDA regulate this?

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?

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.

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.

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.

~~~
sk5t
The FDA maintains it is within the administration's purview to regulate tests
--including laboratory-developed tests, or LDTs--although the current state is
that the FDA often elects to exercise its discretion to permit LDTs sans
regulation-as-medical-device provided the lab adheres to CLIA and has any
required accreditation in order.

Dietary supplements are more or less unregulated, as long as they don't claim
to diagnose or treat a disease. This is not exactly a great situation for
consumers. Also, the current administration has taken sort of a "safety over
efficacy" tack, but I don't know, therapeutic failure seems pretty bad, so
maybe there isn't that much meaningful difference between the two.

Back to the testing concept, if not for the FDA to come down on operations
like Theranos, then who?

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glenra
> if not for the FDA to come down on operations like Theranos, then who?

Theranos was committing fraud - selling investors a product that didn't exist.
You don't need the FDA for fraud to be illegal, ordinary civil and financial
law covers this.

If Theranos _weren 't_ defrauding investors and actually had a product that
worked, it'd be up to the market to determine if that product were worth
paying for. Since different customers have different risk profiles there's no
one-size-fits-all best balance between safety, efficacy and cost - let people
buy different products that choose different tradeoffs.

~~~
IvyMike
Theranos was in fact testing people, who received both false negative and
false negative results.

From the article I link below:

> At its height, Theranos operated 40 “Wellness Centers” in Walgreens stores
> in Arizona and a single location in California, which were the source of
> much of its revenue. USA Today reported the metro Phoenix-area centers alone
> sold more than 1.5 million blood tests, which yielded 7.8 million tests
> results for nearly 176,000 consumers.

[https://www.darkdaily.com/previously-high-flying-theranos-
pr...](https://www.darkdaily.com/previously-high-flying-theranos-provides-
clinical-laboratories-and-pathology-groups-with-valuable-lesson-on-how-
quickly-consumer-trust-can-be-lost/)

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droopyEyelids
Anyone know what mechanism this test uses? I didn't see it in a skim of the
article.

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.

But maybe if this is an antibody test, that won't matter?

~~~
usrusr
The decisive absence of this information in the article leads me to assume
that it has all the same properties (and reagent demands) as existing PCR
tests, just aimed at a simpler sample acquisition process. If there were
further advantages they surely would have written about them. Perhaps the RNA
signatures the test is looking for are shorter or something like that, to tune
the test sensitivity, but I could just as well imagine that it's purely a
paperwork difference. Wasting test capacity on samples acquired in a non-
approved way would be reckless when done at grassroots level, but if the
manufacturer can clear a relaxed sampling process it can be a valuable
improvement.

Paperwork-heavy engineering disciplines are full of examples where the exact
same hardware got re-rated to higher performance levels once the necessary
experience was accumulated. It's not necessarily a bad thing.

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

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edtruji
Sensitivity and specificity rate of this test?

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mrfusion
Will this be an antibody test?

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eganist
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-...](https://www.fda.gov/emergency-preparedness-and-response/mcm-
legal-regulatory-and-policy-framework/emergency-use-authorization)

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...](https://www.fda.gov/news-
events/approvals-fda-regulated-products/about-fda-product-approval)

\---

@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!

~~~
ceejayoz
Is it misleading, or are they just using lay terminology in a press release
aimed at lay people?

They were approved to begin emergency use without the usual steps to "FDA
approval", correct?

~~~
usrusr
Easy english could be a reasonable excuse if the precise terminology would be
indecipherable to laypersons, but I don't see that here. "FDA grants emergency
use authorization [...]" would give the exactly same diffuse "they allowed
something on some level" information to people like me who are unaware of the
specifics, but without ruining it for those in the know.

~~~
ceejayoz
I mean, the subheadline is, in large bold text:

> Emergency use authorization granted for new biomaterial collection approach

They're not hiding anything here, as far as I can tell.

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anorphirith
Any of these companies involved have tickers ?

