7 ms·

FDA approves first rapid coronavirus test with 45 minutes detection time

51 points by valiant-comma 7y ago

LatteLazy 7y ago
Just to be cynical for a moment, does anyone actually respect the fda this? Didn't they refuse to use other countries tests, build their own, approve their own, then discover their one didn't work? Id be much happier to have an independent scientist say "this seems to work based on a few tests" then the fda say "we approve this (maybe because we have to be seen to do a something or maybe because it actually does)"
- SpicyLemonZest 7y ago
  That was the CDC. The FDA doesn't develop tests - their only role here is to ban people from using tests that have been developed.
- turdnagel 7y ago
  That was the CDC. The article says the tests were successfully tested in China.
- AnthonyMouse 7y ago
  The FDA makes sense as an independent entity that does impartial comprehensive testing, because you need somebody to figure out if something really works who isn't motivated by wanting to sell it to you. But their role should be advisory. If they run a trial and it shows that a given drug has a given effectiveness and particular side effects, they should publish that information and be done. Then it should be up to you and your doctor whether it's something that makes sense for you. They shouldn't be in the business of prohibiting stuff -- especially when the only reason they have for prohibiting it is that they haven't gotten around to testing it yet.
pmoriarty 7y ago
Here's a test that works in 15 minutes: https://www.biospace.com/article/releases/20-20-bioresponse-to-launch-rapid-coronavirus-test-kits-in-u-s-following-green-light-from-fda/ https://www.biospace.com/article/releases/20-20-bioresponse-...
- ohazi 7y ago
  That's an antibody detection test, not an RNA sequencing test. You need to have had the virus for long enough for your body to have started to produce antibodies against the virus. It's useful for determining whether the cough you had last week was or wasn't coronavirus, but not so good for early detection.
  - selectodude 7y ago
    Which is useful in its own way. Allows you to stop worrying about getting it again (assuming it doesn’t mutate).
    - pmoriarty 7y ago
      Even if it doesn't mutate it might be possible to get it again due to a weakening of acquired immunity over time. This possibility was discussed on episode 591 on This Week in Virology.[1] I wrote up a transcript of the relevant segment here: [2] [1] - http://www.microbe.tv/twiv/twiv-591/ http://www.microbe.tv/twiv/twiv-591/ about 15 minutes and 50 seconds in to the program [2] - https://news.ycombinator.com/item?id=22609136 https://news.ycombinator.com/item?id=22609136
omosubi 7y ago
Does anyone else find it a little worrying that the FDA is just rubber stamping these? Am I justified in my concern or is that what they had been doing pre-coronavirus but with more lede time? I understand the gravity of the situation, but it seems like little oversight could lead to worse outcomes
- mirimir 7y ago
  > The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems globally, the company said, without giving details. So this doen't seem to be some speculative thing. What's different from their other tests is the RNA target. And that's public knowledge. So it's arguably just procedural.
- maxerickson 7y ago
  An established manufacturer of lab tests actually has quite a lot of incentive to produce tests that work. I also wonder how different this approval is in terms of meaningful scrutiny from a normal approval.
- 75dvtwin 7y ago
  my understanding is that Cepheid has 23,000 testing machines. 5,000 of them are in US. The new test cartridge will work on existing machines. [1] FDA approval is for the specific test, not for the machine itself (as those did not need to change). I was searching for analogous situation, where these machines were able to accurately detect other infections and it seems that they were able to perform at 100% for flu-A at 100% accuracy. [2] My impression sofar, is that FDA was definitely asked to work faster and more efficient, but it does not seem like that they had 'cut corners' so to speak, and approved something out of the 'blue'. [1]https://www.lucianne.com/2020/03/21/rapid_coronavirus_test_approvedbrby_fda_results_in_45_minutes_30086.html https://www.lucianne.com/2020/03/21/rapid_coronavirus_test_a... [2]https://www.labmedica.com/microbiology/articles/294780980/point-of-care-molecular-tests-compared-for-pediatric-influenza.html https://www.labmedica.com/microbiology/articles/294780980/po...
dang 7y ago
https://news.ycombinator.com/item?id=22650843 https://news.ycombinator.com/item?id=22650843

51 points by valiant-comma 7y ago

Just to be cynical for a moment, does anyone actually respect the fda this? Didn't they refuse to use other countries tests, build their own, approve their own, then discover their one didn't work? Id be much happier to have an independent scientist say "this seems to work based on a few tests" then the fda say "we approve this (maybe because we have to be seen to do a something or maybe because it actually does)"

SpicyLemonZest 7y ago
That was the CDC. The FDA doesn't develop tests - their only role here is to ban people from using tests that have been developed.
turdnagel 7y ago
That was the CDC. The article says the tests were successfully tested in China.
AnthonyMouse 7y ago
The FDA makes sense as an independent entity that does impartial comprehensive testing, because you need somebody to figure out if something really works who isn't motivated by wanting to sell it to you. But their role should be advisory. If they run a trial and it shows that a given drug has a given effectiveness and particular side effects, they should publish that information and be done. Then it should be up to you and your doctor whether it's something that makes sense for you. They shouldn't be in the business of prohibiting stuff -- especially when the only reason they have for prohibiting it is that they haven't gotten around to testing it yet.

pmoriarty 7y ago

Here's a test that works in 15 minutes: https://www.biospace.com/article/releases/20-20-bioresponse-to-launch-rapid-coronavirus-test-kits-in-u-s-following-green-light-from-fda/ https://www.biospace.com/article/releases/20-20-bioresponse-...

ohazi 7y ago
That's an antibody detection test, not an RNA sequencing test. You need to have had the virus for long enough for your body to have started to produce antibodies against the virus. It's useful for determining whether the cough you had last week was or wasn't coronavirus, but not so good for early detection.
- selectodude 7y ago
  Which is useful in its own way. Allows you to stop worrying about getting it again (assuming it doesn’t mutate).
  - pmoriarty 7y ago
    Even if it doesn't mutate it might be possible to get it again due to a weakening of acquired immunity over time. This possibility was discussed on episode 591 on This Week in Virology.[1] I wrote up a transcript of the relevant segment here: [2] [1] - http://www.microbe.tv/twiv/twiv-591/ http://www.microbe.tv/twiv/twiv-591/ about 15 minutes and 50 seconds in to the program [2] - https://news.ycombinator.com/item?id=22609136 https://news.ycombinator.com/item?id=22609136

omosubi 7y ago

Does anyone else find it a little worrying that the FDA is just rubber stamping these? Am I justified in my concern or is that what they had been doing pre-coronavirus but with more lede time? I understand the gravity of the situation, but it seems like little oversight could lead to worse outcomes

mirimir 7y ago
> The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems globally, the company said, without giving details. So this doen't seem to be some speculative thing. What's different from their other tests is the RNA target. And that's public knowledge. So it's arguably just procedural.
maxerickson 7y ago
An established manufacturer of lab tests actually has quite a lot of incentive to produce tests that work. I also wonder how different this approval is in terms of meaningful scrutiny from a normal approval.
75dvtwin 7y ago
my understanding is that Cepheid has 23,000 testing machines. 5,000 of them are in US. The new test cartridge will work on existing machines. [1] FDA approval is for the specific test, not for the machine itself (as those did not need to change). I was searching for analogous situation, where these machines were able to accurately detect other infections and it seems that they were able to perform at 100% for flu-A at 100% accuracy. [2] My impression sofar, is that FDA was definitely asked to work faster and more efficient, but it does not seem like that they had 'cut corners' so to speak, and approved something out of the 'blue'. [1]https://www.lucianne.com/2020/03/21/rapid_coronavirus_test_approvedbrby_fda_results_in_45_minutes_30086.html https://www.lucianne.com/2020/03/21/rapid_coronavirus_test_a... [2]https://www.labmedica.com/microbiology/articles/294780980/point-of-care-molecular-tests-compared-for-pediatric-influenza.html https://www.labmedica.com/microbiology/articles/294780980/po...

dang 7y ago

https://news.ycombinator.com/item?id=22650843 https://news.ycombinator.com/item?id=22650843