The Food and Drug Administration (FDA) that massively screwed up COVID-19 testing now wants to apply its vast bureaucratic acumen to all other laboratory developed tests (LDTs). By insisting on its recondite approval procedures, the FDA at the beginning of the pandemic stymied the rollout of COVID-19 tests developed by numerous academic and private laboratories. In contrast, public health authorities in South Korea greenlighted an effective COVID-19 test just one week (and many more in the weeks following) after asking representatives from 20 private medical companies to produce such tests.
LDTs are diagnostic in vitro tests for clinical use that are designed, manufactured, and performed by individual laboratories. They can diagnose illnesses and guide treatments by detecting relevant biomarkers in saliva, blood, or tissues; the tests can identify small molecules, proteins, RNA, DNA, cells, and pathogens. For example, some assess the risks of developing Alzheimer's disease or guide the treatment of breast cancer.
