3 ms·

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-coro

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...

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...