4 ms·

This is pretty similar to the 23andme shutdown years ago, and for the same reason. The FDA regulates what kind of “medical advice” you are giving. From the arti

by boulos 6y ago

This is pretty similar to the 23andme shutdown years ago, and for the same reason. The FDA regulates what kind of “medical advice” you are giving. From the article: > The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients. > “We had previously understood that SCAN was being conducted as a surveillance study,” the spokesperson said. ... > Dr. Topol said it would not make sense to have people swab their noses and then not give them their test results. > “To withhold that information from people is downright absurd,” Dr. Topol said. While I agree with the sentiment, the 23andme situation provides a useful counter balance: if you provide untrained people with inaccurate results, is that better or worse? In the 23andme case there was a worry that people might commit suicide or make massive life changes, if they discovered they had a potential terminal illness. Here, the 2x2 matrix of positive vs negative and true vs false, seems most dangerous on the false-positive side for people who believe it grants them freedom to do whatever they like. False negatives are dangerous for those who then feel certain they don’t have the disease currently and thus expose others unwittingly (but this is already likely!). So I dunno, I bet they’ll review this somewhat quickly (the group sent their FDA materials in a few weeks ago according to the article) particularly once they have a tighter estimate on the false positive and negative rates.

adrr 6y ago
Public health is controlled by the state though. FDA shouldn’t have jurisdiction in preventing a state from taking actions to control an outbreak.
- loeg 6y ago
  The FDA doesn't object to the surveillance study, just the part where SCAN actually give individual test results to study participants ("diagnosis"). Nevermind that the informed consent form has explicitly told study participants they might get their results ("diagnosis") since early March, after the last time the FDA "helped": https://pastebin.com/wj6fMnrw https://pastebin.com/wj6fMnrw
  - adrr 6y ago
    Doesn’t matter, testing the populace for public health matter like trying to control an outbreak is the right of the state. Telling people results is needed so people can self quarantine. State has the ultimate authority. Washington should tell the Feds to go pound sand on anything covid related including what tests to use. There are multiple Supreme Court rulings on this matter.
    - loeg 6y ago
      > testing the populace for public health matter like trying to control an outbreak is the right of the state. Telling people results is needed so people can self quarantine. I agree with this part. As to the rest, I am not a lawyer.
anewvillager 6y ago
> In the 23andme case there was a worry that people might commit suicide or make massive life changes, if they discovered they had a potential terminal illness. Here, the 2x2 matrix of positive vs negative and true vs false, seems most dangerous on the false-positive side for people who believe it grants them freedom to do whatever they like. False negatives are dangerous for those who then feel certain they don’t have the disease currently and thus expose others unwittingly (but this is already likely!). So you suggest it's better to not test people?
- jmchuster 6y ago
  Isn't that the suggestion? That if there are groups of individuals who you know are going to make wildly irresponsible choices because they don't have the ability to interpret such information, you would prefer not to give it to them?
  - greglindahl 6y ago
    It's entirely reasonable to assume that tests with high error rates cause problems for everyone, not just "groups of individuals who you know are going to make ..." For example, a PhD biologist friend of mine agonized for months before she was willing to look at her personal 23-and-me results, after the FDA certified them as accurate enough to show to consumers. It's a real problem for everyone.
- boulos 6y ago
  No, I was just calling out the "you know, the outcomes just aren't that bad here". As I ended on, I think they'll come to the conclusion relatively quickly that there is minimal risk to the public from having such diagnoses, even if they're misinterpreted.
loeg 6y ago
So unlike 23andme, (1) realtime COVID diagnosis is extremely timely and actionable to recipients and has a real impact on disease spread, (2) the SCAN tests are reliable, targeted, and they have the data to support that, and (3) a positive or negative COVID test seems unlikely to induce suicide, or I don't know, a murder spree. So I don't think this comparison is especially suitable. In addition, the informed consent form for participants has included language that results might be shared since early March: https://pastebin.com/wj6fMnrw https://pastebin.com/wj6fMnrw So the FDA, in May, claiming to think the study was only surveillance suggests to me a remarkable failing of comprehension by the FDA. > The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test > We have been in conversation with the FDA since March 1st and hope to have our EUA soon. We initiated the process to authorize our lab-developed test and self-swab kit on March 23rd and, in accordance with the EUA process and timeline, submitted data to secure federal authorization on April 13th. We are actively working to address their questions and resume testing as soon as possible. > We have performed internal studies to determine shipping and specimen stability with our assay, testing approximately 17,000 home-collected mid-turbinate swabs from both adults and children—including Seattle Flu Study and SCAN samples. We have provided the following information to the FDA: > To date, only a single, minor adverse event has been reported. > Our shipping and stability studies have established that detection of SARS-CoV-2 is stable for over a week at high and low regional temperatures. > With regard to proper specimen collection outside of a clinical setting, our experience from more than 18 months of sampling with the Seattle Flu Study and now SCAN also shows a low rate of insufficient nasal sampling. The internal control in our assay readily identifies whether a sufficient specimen is collected. > Numerous scientific studies have established similar rates of detection for mid-turbinate swabs and the nasal pharyngeal swabs typically used in clinical testing, including for SARS-CoV-2 detection. The Infectious Diseases Society of America (IDSA) guidelines endorse the use of mid-turbinate swabs and reference the potential for self-collection with appropriate instructions. https://scanpublichealth.org/updates/2020-05-13 https://scanpublichealth.org/updates/2020-05-13

by boulos 6y ago

adrr 6y ago

Public health is controlled by the state though. FDA shouldn’t have jurisdiction in preventing a state from taking actions to control an outbreak.

loeg 6y ago
The FDA doesn't object to the surveillance study, just the part where SCAN actually give individual test results to study participants ("diagnosis"). Nevermind that the informed consent form has explicitly told study participants they might get their results ("diagnosis") since early March, after the last time the FDA "helped": https://pastebin.com/wj6fMnrw https://pastebin.com/wj6fMnrw
- adrr 6y ago
  Doesn’t matter, testing the populace for public health matter like trying to control an outbreak is the right of the state. Telling people results is needed so people can self quarantine. State has the ultimate authority. Washington should tell the Feds to go pound sand on anything covid related including what tests to use. There are multiple Supreme Court rulings on this matter.
  - loeg 6y ago
    > testing the populace for public health matter like trying to control an outbreak is the right of the state. Telling people results is needed so people can self quarantine. I agree with this part. As to the rest, I am not a lawyer.

anewvillager 6y ago

> In the 23andme case there was a worry that people might commit suicide or make massive life changes, if they discovered they had a potential terminal illness. Here, the 2x2 matrix of positive vs negative and true vs false, seems most dangerous on the false-positive side for people who believe it grants them freedom to do whatever they like. False negatives are dangerous for those who then feel certain they don’t have the disease currently and thus expose others unwittingly (but this is already likely!). So you suggest it's better to not test people?

jmchuster 6y ago
Isn't that the suggestion? That if there are groups of individuals who you know are going to make wildly irresponsible choices because they don't have the ability to interpret such information, you would prefer not to give it to them?
- greglindahl 6y ago
  It's entirely reasonable to assume that tests with high error rates cause problems for everyone, not just "groups of individuals who you know are going to make ..." For example, a PhD biologist friend of mine agonized for months before she was willing to look at her personal 23-and-me results, after the FDA certified them as accurate enough to show to consumers. It's a real problem for everyone.
boulos 6y ago
No, I was just calling out the "you know, the outcomes just aren't that bad here". As I ended on, I think they'll come to the conclusion relatively quickly that there is minimal risk to the public from having such diagnoses, even if they're misinterpreted.

loeg 6y ago

So unlike 23andme, (1) realtime COVID diagnosis is extremely timely and actionable to recipients and has a real impact on disease spread, (2) the SCAN tests are reliable, targeted, and they have the data to support that, and (3) a positive or negative COVID test seems unlikely to induce suicide, or I don't know, a murder spree. So I don't think this comparison is especially suitable. In addition, the informed consent form for participants has included language that results might be shared since early March: https://pastebin.com/wj6fMnrw https://pastebin.com/wj6fMnrw So the FDA, in May, claiming to think the study was only surveillance suggests to me a remarkable failing of comprehension by the FDA. > The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test > We have been in conversation with the FDA since March 1st and hope to have our EUA soon. We initiated the process to authorize our lab-developed test and self-swab kit on March 23rd and, in accordance with the EUA process and timeline, submitted data to secure federal authorization on April 13th. We are actively working to address their questions and resume testing as soon as possible. > We have performed internal studies to determine shipping and specimen stability with our assay, testing approximately 17,000 home-collected mid-turbinate swabs from both adults and children—including Seattle Flu Study and SCAN samples. We have provided the following information to the FDA: > To date, only a single, minor adverse event has been reported. > Our shipping and stability studies have established that detection of SARS-CoV-2 is stable for over a week at high and low regional temperatures. > With regard to proper specimen collection outside of a clinical setting, our experience from more than 18 months of sampling with the Seattle Flu Study and now SCAN also shows a low rate of insufficient nasal sampling. The internal control in our assay readily identifies whether a sufficient specimen is collected. > Numerous scientific studies have established similar rates of detection for mid-turbinate swabs and the nasal pharyngeal swabs typically used in clinical testing, including for SARS-CoV-2 detection. The Infectious Diseases Society of America (IDSA) guidelines endorse the use of mid-turbinate swabs and reference the potential for self-collection with appropriate instructions. https://scanpublichealth.org/updates/2020-05-13 https://scanpublichealth.org/updates/2020-05-13