[Expanding scope and impact of services provided by clinical laboratory practice through molecular diagnostics]

Recent progress in molecular biology and biotechnology has facilitated assays for DNA or RNA sequences to diagnose infectious, neoplastic and genetic diseases. Many of the assays have been used clinically, and are now an essential part of patient care under advanced medicine. A clinical laboratory needs to ensure services for clinical needs such as provision of tests with required turnaround time and high quality as well as consulting practice for individual requests. For quality assurance of assays, it is particularly important to monitor clinical validation of the results by correlating them with the patient's status to prove clinically relevant. Staff need to be trained to become familiar with both molecular pathogenesis and technology so that they can provide informative tests with high quality. Along with advances in pharmacogenomics, the findings of the human genome project have raised the prospect of developing tests for individualized medicine based on genetic information such as those predicting individual susceptibility to diseases to facilitate prevention and indicate responsiveness to drugs for choice of treatment. Molecular diagnostic tests will contribute to an efficient process of decision making on patient care and result in cost savings through earlier and more accurate diagnosis. The scope and impact of services provided by clinical laboratory practice through molecular diagnostics will continue to expand in its integration into clinical practice.