Laboratory developed tests in the clinical laboratory: challenges for implementation

“The impetus of laboratory developed tests was to address the unmet needs of providers to assist in patient care... The proposed guidance materials could hamper such care...” The recent release of a draft guidance document on the regulation of laboratory developed tests (LDTs) by the US FDA has led to intense discussion by many stakeholders, including those in the public and private sectors. However, in order to fully engage in the conversation, it is imperative that one understands the definition of an LDT, the origins of oversight for clinical laboratory testing, and the potential implications to the most important stakeholder:...