Laboratory developed tests in the development of modern medicine: opportunities and challenges / 中华检验医学杂志

ABSTRACT

Translational medicine and personalized medicine are becoming the new power in modem medical development.Laboratory Developed Tests (LDTs) based on molecular biology and bioinformatics technology play a vital role in the development process of translational medicine and personalized medicine.Nowadays,LDTs consist of a broad range of in vitro diagnositc tests performed to analyze nucleic acid,chromosomes,proteins,certain metabolites and cell surface molecules using immunological technique,cytogenetic or molecular methods or a combination of these methods.These LDTs are used to detect heritable or acquired disease-related genotypes,mutations,or phenotypes,and also used to classify the pathological changes of cells for clinical purposes.New generation LDTs,present some unique regulatory questions still remain to be discussed.Clinicians should capture the opportunity to establish and continuously improve the detection platforms of LDTs,the quality control system and management standards.On this basis,transformation bridges between scientific research and clinical application will be truly built.