![]() ![]() Sequencing and cDNA cloning were critical for establishing basic knowledge on the primary sequence of various genes. ![]() MDx grew from the early days of recombinant DNA technology. While the ongoing SARS-CoV-2 / COVID-19 pandemic helped make molecular terms like ‘polymerase chain reaction’ (PCR), ‘false positive’ and ‘variant’ common, the field actually dates to 1949 with Linus Pauling and colleagues’ characterization of sickle cell anemia as a ‘molecular disease.’ However, it took decades for the scientific discipline of molecular biology to develop and become usable in the medical laboratory as a basis for disease diagnostics. Historical and Current Examples of Molecular Diagnostics For the first time in the history of the diagnostic laboratory, molecular pathology and diagnostics are extending the range of information available to physicians, pharmacists, geneticists, forensic scientists, research scientists and other healthcare professionals. The completion of the Human Genome Project and the rapid advancement of technology to arise out of that effort has moved from the research bench to the clinical laboratory bench with swift success. In the last decade or so, the clinical laboratory has seen an explosion in the available menu of tests based upon DNA and RNA analysis. Molecular diagnostic techniques and platforms are playing a larger and more critical role in all areas of anatomic and clinical pathology. Molecular diagnostics (MDx) is the rapidly developing area of laboratory medicine that investigates human, viral and microbial genomes and the products they encode.
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