companies like Quest or LabCorp, or by academic institutions, are free to fashion their own laboratory developed tests, known as LDTs, for detecting a viral pathogen. These LDTs are subject to the FDA’s oversight, but for most of these tests, the agency has exercised “enforcement discretion” and has chosen not to apply regulatory requirements—so long as the LDTs are run inside the sophisticated labs that assembled them and vouch for their quality and precision, and the tests are not turned into kits and resold to other labs. But when it came to COVID testing, things changed once the public
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