7 ms·

FDA grants emergency authorization for first saliva-based coronavirus test

111 points by new_time 6y ago

selectodude 6y ago
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.
- fspeech 6y ago
  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 6y ago
    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-coronavirus-tests-sow-worry-11585836001?mod=e2tw https://www.wsj.com/articles/questions-about-accuracy-of-cor...
- deleted 6y ago
  [deleted]
droopyEyelids 6y ago
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 6y ago
  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.
- nijave 6y ago
  RNA based https://www.phillyvoice.com/covid-19-rapid-test-saliva-rutgers-coronavirus-new-jersey-genetics-accurate-diagnostic-labs/ https://www.phillyvoice.com/covid-19-rapid-test-saliva-rutge...
crystalmeph 6y ago
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 6y ago
  I am fairly confident your option A is absolutely not an option.
  - crystalmeph 6y ago
    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 6y ago
      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.
anorphirith 6y ago
Any of these companies involved have tickers ?
- deleted 6y ago
  [deleted]
eganist 6y ago
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-legal-regulatory-and-policy-framework/emergency-use-authorization 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-products/about-fda-product-approval 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!
- ceejayoz 6y ago
  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 6y ago
    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 6y ago
      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.
deleted 6y ago
[deleted]
KaiserPro 6y ago
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 6y ago
  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-covid-19/#.XpTGupp7mEI https://hitconsultant.net/2020/04/03/fda-24-hour-saliva-test...
  - Atlas 6y ago
    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."
edtruji 6y ago
Sensitivity and specificity rate of this test?
mrfusion 6y ago
Will this be an antibody test?
setgree 6y ago
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.
- mjcl 6y ago
  The legislation that created the FDA (the Food, Drug & Cosmetic Act) defines drugs to include "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals". See https://www.law.cornell.edu/uscode/text/21/321 https://www.law.cornell.edu/uscode/text/21/321, section 321 (g)(1)(B).
- sk5t 6y ago
  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?
  - smooth_remmy 6y ago
    > 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. If dietary supplements were regulated, they would probably 1) cost 10x as much 2) be prescription-only 3) only be affordable through health insurance 4) there would be 1/10th the innovation compared to what we see now. I'm a consumer who consumes a basic set of supplements (vitamin d, vitamin k2, magnesium, multivitamin) and I'm very happy with how things are now. I'm glad that the extreme level of waste, red tape, and corruption that affects the rest of the medical industry does not affect dietary supplements.
LatteLazy 6y ago
Does this mean the fda actually tested it or is it just the official stamp of not being banned (yet)?

111 points by new_time 6y ago

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.

fspeech 6y ago
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 6y ago
  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-coronavirus-tests-sow-worry-11585836001?mod=e2tw https://www.wsj.com/articles/questions-about-accuracy-of-cor...
deleted 6y ago
[deleted]

droopyEyelids 6y ago

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 6y ago
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.
nijave 6y ago
RNA based https://www.phillyvoice.com/covid-19-rapid-test-saliva-rutgers-coronavirus-new-jersey-genetics-accurate-diagnostic-labs/ https://www.phillyvoice.com/covid-19-rapid-test-saliva-rutge...

crystalmeph 6y ago

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 6y ago
I am fairly confident your option A is absolutely not an option.
- crystalmeph 6y ago
  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 6y ago
    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.

anorphirith 6y ago

Any of these companies involved have tickers ?

deleted 6y ago
[deleted]

eganist 6y ago

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-legal-regulatory-and-policy-framework/emergency-use-authorization 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-products/about-fda-product-approval 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!

ceejayoz 6y ago
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 6y ago
  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 6y ago
    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.

deleted 6y ago

[deleted]

KaiserPro 6y ago

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 6y ago
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-covid-19/#.XpTGupp7mEI https://hitconsultant.net/2020/04/03/fda-24-hour-saliva-test...
- Atlas 6y ago
  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."

edtruji 6y ago

Sensitivity and specificity rate of this test?

mrfusion 6y ago

Will this be an antibody test?

setgree 6y ago

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.

mjcl 6y ago
The legislation that created the FDA (the Food, Drug & Cosmetic Act) defines drugs to include "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals". See https://www.law.cornell.edu/uscode/text/21/321 https://www.law.cornell.edu/uscode/text/21/321, section 321 (g)(1)(B).
sk5t 6y ago
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?
- smooth_remmy 6y ago
  > 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. If dietary supplements were regulated, they would probably 1) cost 10x as much 2) be prescription-only 3) only be affordable through health insurance 4) there would be 1/10th the innovation compared to what we see now. I'm a consumer who consumes a basic set of supplements (vitamin d, vitamin k2, magnesium, multivitamin) and I'm very happy with how things are now. I'm glad that the extreme level of waste, red tape, and corruption that affects the rest of the medical industry does not affect dietary supplements.

LatteLazy 6y ago

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