The U.S. Food and Drug Administration (FDA) published the final rule on laboratory developed tests (LDTs) on Monday, aimed at enhancing the safety and effectiveness of these diagnostics. The new regulation, anticipated following Congress's failure to pass the VALID Act, will provide the FDA with greater oversight over clinical laboratories. This rule is expected to impact around 12,000 labs that will now need to submit their tests for FDA approval. The regulation targets tests used in diagnosing serious conditions like cancer and Alzheimer's disease, addressing concerns about their reliability and the risks they pose to patients. The FDA has scheduled a media call to discuss the action and anticipates legal challenges regarding the new rule.