Framework for Regulatory Oversight of Laboratory Developed Tests
Laboratory developed test (LDT) is a term used to refer to a certain type of in vitro diagnostics and medical professionals have used LDTs to diagnose diseases. LDTs nowadays have evolved and proliferated significantly in precision medicine, shedding further light on disease management and leading to actionable interventions. However, besides a highly-sophisticated laboratory, LDTs require well-trained professionals with considerable expertise, knowledge, and experience. With advances in technology and business models, the LDT oversights are being discussed. LDTs have direct effect on the care that patients receive; therefore, patient safety must always be the top priority. The article not only aims to review the regulatory oversights and governance in the U.S. and the European Union but also addresses the current legal concerns in Taiwan.