Laboratory developed tests in the development of modern medicine: opportunities and challenges
10.3760/cma.j.issn.1009-9158.2015.01.004
- VernacularTitle:实验室自建项目在现代医学发展中面临的机遇和挑战
- Author:
Yu WU
;
Gusheng TANG
;
Qian SHEN
- Publication Type:Journal Article
- Keywords:
Translational medical research;
Individualized medicine;
Clinical laboratory technique;
Molecular diagnostic techniques
- From:
Chinese Journal of Laboratory Medicine
2015;38(1):10-12
- CountryChina
- Language:Chinese
-
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.
