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"Why the CDC botched its coronavirus testing"

The  next time some government official urges you not to "panic," remind him or her of the sharp limit on the competence of the federal government. From the MIT Technology Review:

According to Duane Newton, the director of clinical microbiology at the University of Michigan, the biggest limitation in diagnostics is not the technology, but rather the regulatory approval process for new tests and platforms. While this process is critical for ensuring safety and efficacy, the necessary delays often “hamper the willingness and ability of manufacturers and laboratories to invest resources into developing and implementing new tests,” he says.

Case in point: FDA rules initially prevented state and commercial labs from developing their own coronavirus diagnostic tests, even if they could develop coronavirus PCR primers on their own. So when the only available test suddenly turned out to be bunk, no one could actually say what primer sets worked.

From the Washington Post:

The traditional U.S. strategy for devising new diagnostic tests starts with the CDC. That is supposed to ensure new tests are accurate and reliable, but it also meant that other parallel approaches were not aggressively pursued.

From the City Journal, "A Self-Inflicted Crisis: Overregulation has played a dangerous role in America’s coronavirus outbreak":

The FDA has not allowed the experienced and highly skilled professionals at public-health, academic, and commercial laboratories to set up their own laboratory developed tests.

From a source with an ax to grind, but interesting: "An Obama Holdover in an Obscure Government Arm Helped Cause the Country’s Coronavirus Crisis".

And finally scroll a few screens to the bottom of this post and see a California government official contradict her own coronavirus advice.

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