After debacles at both CDC and FDA, the public has been demanding that government bureaucracy stop holding back innovation so FDA loosened the approval cycle for new labs to be able to conduct coronavirus tests, loosened bizarre restrictions on the ability of new companies to make hand sanitizer, and has now granted emergency authorization for the world's first rapid point-of-care test, to the Sunnyvale company.
Only about 200,000 people have been tested for the virus outside hospitals or health labs. That has uncovered 19,000 positive cases. This new test will get testing into the hands of a lot more doctors.
With existing tests, a swab must be taken and then sent to a government-designated lab. Then days later results would come back. It is all very centralized authority and ideal for government control, which means it is a deterrent to public health when pandemics occur.
The Xpert Xpress SARS-CoV-2 approval means means any of Cepheid's more than 23,000 automated GeneXpert Systems in use can get SARS-CoV-2 detection down to approximately 45 minutes.
The modification of Xpert Xpress Flu/RSV cartridge technology, which looks at regions of the viral genome, to detect SARS-CoV-2, was likely the easiest part. In the business-as-usual government regimen, this would be two years and a fortune just to change a product to detect a new virus.
If fewer FDA roadblocks to innovation are the new normal, that is a good thing, but some aspects of American culture have not changed. Lawyers are already lining up to sue Purell, claiming it's hand sanitizer does not work as well as FDA and the company claim. If there is one thing that does not take a break during a public health emergency, it's greed.
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