FDA Issues Final Rule on LDTs

Abstract: The FDA issued a final rule for regulating laboratory-developed tests (LDT) in May. The rule could lead to greater accuracy and consistency from one test to another, but it could also decrease access to testing, while increasing the cost of some clinical trials and potentially stifling innovation. The agency has indicated that some LDTs could be exempted from enforcement, including certain IHC and FISH tests, if they meet the FDA’s policy.