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Molecular testing is critical to the profession of laboratory medicine, and so physicians must understand the challenges of these technologies and how to use them properly.
FREMONT, CA: Molecular diagnostics (MDx) is a rapidly expanding branch of laboratory medicine that studies human, viral, and microbial genomes and the products they encode. Molecular diagnostic techniques and platforms are becoming more prevalent and essential in all aspects of anatomic and clinical pathology. The clinical laboratory has seen an outburst in the available list of tests based on DNA and RNA analysis over the last decade or so.
The accomplishment of the Human Genome Project and the rapid advancement of technology that has occurred from that effort have resulted in a successful transition from the research bench to the clinical laboratory bench. For the first time in diagnostic laboratory history, molecular pathology and diagnostics broaden the variety of information accessible to physicians, pharmacists, geneticists, forensic scientists, research scientists, and other healthcare providers.
Molecular diagnostics challenges:
The first and foremost direct-specimen molecular testing for infectious diseases was recognized by the U.S. Food and Drug Administration 26 years ago. Since then, the accelerated advancement of molecular technology has been driven mainly by two areas: (1) automated extraction, augmentation, and detection platforms and (2) next-generation sequencing. As with any newly developed area, there are obstacles to overcome that laboratory medicine. Public health must be aware that these developments intersect with patient outcomes, healthcare, and public health policy.
The cost of this advanced technology may lead to even more health outcomes if economic decisions limit the use of MDx to specific communities or populations. Another issue with advanced and quickly implemented MDx platforms is the possibility of over-or under-utilization. Rapid MDx platforms, for example, are frequently more delicate and speedier than traditional culture methods. However, the adoption of these MDx assays has been so rapid that it has surpassed evidence of clinical utility in some cases. Another issue to consider is the need for healthcare professional education. To provide cost-effective and well-informed care to their patients, physicians must understand the fundamentals and challenges of these technologies and how to use them appropriately.
The possibility of a medical laboratory professional performing molecular diagnostic testing has become critical to the profession of laboratory medicine. Knowledge of pathogen detection and surveillance methodology, cancer biomarkers, inherited genetic disorders, and other biomarkers is essential for present and future professionals. The field is presently in need of well-trained medical laboratory professionals with solid biomedical science and medical laboratory science backgrounds, as well as a deep understanding of assay development technologies, who can transcend the current state of practice with ongoing developments in highly complicated testing. Knowledge of methodology related to pathogen detection and surveillance, cancer biomarkers, inherited genetic disorders, and other biomarkers is essential for present and future professionals.
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