Mammoth Biosciences has developed a CRISPR-based COVID19 test, which can be conducted in 30 min, and is trying to expand to being available at the point of care. https://mammoth.bio/wp-content/uploads/2020/03/Mammoth-Biosciences-A-protocol-for-rapid-detection-of-SARS-CoV-2-using-CRISPR-diagnostics-DETECTR.pdf …
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Even to qualify for the FDA's Emergency Use Authorization requires validation of the entire testing workflow. As I understand, it would be illegal (?) to test patients without an EAU.https://www.modernhealthcare.com/technology/labs-face-challenges-creating-diagnosis-testing-covid-19 …
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So while, as Ian tweeted earlier, you don't need an RNA test kit to do an RNA extraction (https://twitter.com/allmeasures/status/1238089400296202243 …) if you gave patients a COVID-19 test based on the "old-fashioned" phenol/chloroform RNA extraction method, that wouldn't be automatically approved.
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I'm struggling to figure out what would happen, concretely, to a doctor who tested patients with unapproved tests, or a laboratory that provided them. (Fines? Loss of license? what are the penalties here?)
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