Federal Court ‘Vacates in Its Entirety’ the FDA’s Costly and Onerous Lab Test Rule
A federal district court has struck a blow for medical innovation and patient empowerment by overruling the Food and Drug Administration’s (FDA) misbegotten effort to regulate laboratory-developed (LDTs) and in vitro testing.
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, detect the presence of cancers, or guide the treatment of breast cancer.
Last May, the agency adopted extensive new rules aimed at regulating those tests for the first time. This is the same agency whose bureaucratic acumen in 2020 massively screwed up COVID-19 diagnostic testing as the pandemic rolled in.
As I reported at the time, out of the billions of tests given annually, the FDA sought to justify imposing its burdensome oversight by citing problematic medical device reports and unconfirmed “allegations” for a grand total of nine and four different tests respectively between 2009 and 2023. The remaining examples cited by the FDA are tests that had actually been submitted to the agency for analysis and were subsequently rejected or revised as recommended.
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