This would be a great choice.
HHS/CDC/FDA has completely fallen down on the job, bottlenecking testing during a critical period.
CDC reports a total of 426 people in the US were tested as of 2/24, a rate of ~12 per day.
But South Korea was at 3000/day. We can do >100X better.
HHS/CDC/FDA has completely fallen down on the job, bottlenecking testing during a critical period.
CDC reports a total of 426 people in the US were tested as of 2/24, a rate of ~12 per day.
But South Korea was at 3000/day. We can do >100X better.
REFERENCES
1) CDC now reports 445 tested in the 36 days since 1/21, a rate of ~12 per day: archive.is/pz8HV
2) South Korea reported testing capability of 3000 per day on 2/8.
en.yna.co.kr/view/AEN202002…
1) CDC now reports 445 tested in the 36 days since 1/21, a rate of ~12 per day: archive.is/pz8HV
2) South Korea reported testing capability of 3000 per day on 2/8.
en.yna.co.kr/view/AEN202002…
This is not due to some technological limitation. The test is standard. It is a form of artificial scarcity, created by HHS/CDC/FDA bureaucracy.
Scott is very diplomatic below, but the TLDR is that FDA is denying local labs the authority to test.
Scott is very diplomatic below, but the TLDR is that FDA is denying local labs the authority to test.
Longer version:
1) Normally, licensed clinical labs can do laboratory developed tests (LDTs) without FDA approval
2) But HHS' declaration of a Public Health Emergency meant FDA gained bottleneck power
3) And they have not approved test kits or issued authorizations to labs
1) Normally, licensed clinical labs can do laboratory developed tests (LDTs) without FDA approval
2) But HHS' declaration of a Public Health Emergency meant FDA gained bottleneck power
3) And they have not approved test kits or issued authorizations to labs
Here's the specific FDA citation.
Translated from bureaucratese, the more serious the emergency, the higher the "risk"...hence the more red tape that will be imposed on test approvals!
Of course, the real risk is being too slow to clear a standard test.
archive.is/wip/lgqI6
Translated from bureaucratese, the more serious the emergency, the higher the "risk"...hence the more red tape that will be imposed on test approvals!
Of course, the real risk is being too slow to clear a standard test.
archive.is/wip/lgqI6
Given the number of cases that competent countries like Singapore & South Korea have detected, we may have an issue in the US.
But if FDA blocks test kit approvals & doesn't give emergency use authorization to labs, everyone can be in denial.
No diagnosis, no cases, no problem.
But if FDA blocks test kit approvals & doesn't give emergency use authorization to labs, everyone can be in denial.
No diagnosis, no cases, no problem.
