Overregulation of diagnostic testing has played a major role in this delay.
The World Health Organization used a freely available German procedure to create a test kit, shipping 250,000 tests to 159 laboratories worldwide.
Meantime, South Korea has more than 500 testing sites and has screened over 100,000 people, reportedly testing 10,000 individuals per day and pioneering "Drive-through" testing facilities.
Laboratory tests typically contain what is termed a "Negative control"-material expected to yield a negative result when tested, and which protects against false-positive results stemming from contamination or other issues.
Affected labs were required to send their specimens to the overburdened CDC. 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, and no manufactured test kits have been authorized for sale in the U.S. In Europe, several companies, at least one U.S.-based, have regulatory approval to sell test kits in Europe.
In general, the FDA has exercised "Enforcement discretion" with respect to LDTs. With coronavirus testing, the FDA's abandonment of enforcement discretion may have proved deadly.
On February 29, the agency issued guidance expanding the number of laboratories eligible to provide testing and creating a pathway for them to use internally developed tests.
https://www.city-journal.org/overregulation-of-diagnostic-testing-coronavirus
The World Health Organization used a freely available German procedure to create a test kit, shipping 250,000 tests to 159 laboratories worldwide.
Meantime, South Korea has more than 500 testing sites and has screened over 100,000 people, reportedly testing 10,000 individuals per day and pioneering "Drive-through" testing facilities.
Laboratory tests typically contain what is termed a "Negative control"-material expected to yield a negative result when tested, and which protects against false-positive results stemming from contamination or other issues.
Affected labs were required to send their specimens to the overburdened CDC. 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, and no manufactured test kits have been authorized for sale in the U.S. In Europe, several companies, at least one U.S.-based, have regulatory approval to sell test kits in Europe.
In general, the FDA has exercised "Enforcement discretion" with respect to LDTs. With coronavirus testing, the FDA's abandonment of enforcement discretion may have proved deadly.
On February 29, the agency issued guidance expanding the number of laboratories eligible to provide testing and creating a pathway for them to use internally developed tests.
https://www.city-journal.org/overregulation-of-diagnostic-testing-coronavirus
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