The American Clinical Laboratory Association and HealthTrackRx have sued the FDA over plans to regulate lab-developed tests, claiming the agency lacks authority. Historically, lab tests were unregulated, but the rise of complex tests led to unreliable results harming patients. Examples include Theranos’ blood tests and misleading genetic tests. The FDA’s finalization of test regulation last month prompted the lawsuit, with experts predicting industry pushback. The suit challenges the FDA’s ability to regulate lab tests, which have long been in a regulatory gray area. The lawsuit signifies a growing concern over the reliability and safety of lab-developed tests.
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Lab trade group sues FDA to halt regulation of lab-developed tests
