Introduction To Molecular Diagnostics


Molecular diagnostics has become a growing part of the clinical laboratory. It includes all tests and methods to identify a disease and understand the predisposition for a disease analyzing DNA or RNA of an organism. Rapid advances in molecular diagnostics enables basic research and results in practical diagnostic tests .The basic application is to determine changes in sequence or expression levels in crucial genes involved in disease. The use of molecular diagnostics, such as pre-implantation diagnostics or predictive genetic testing, still has technical problems as well as novel, and to date unclear, social, ethical and legal implications. The scope of molecular diagnostics in molecular medicine could be expanded well beyond current nucleic acid testing.  It plays an important role in practice of medicine, public health, pharmaceutical industry, forensics and biological warfare and drug discovery. The molecular diagnostic marketplace offers a growth opportunity given the interest in utilizing molecular tools to precisely target therapeutics.
 Key words  
 Clinical diagnostics, molecular biology, DNA, RNA, Health care, molecular diagnostics, genetics,, diagnostic medicine ,prognostic , molecular diagnostic industry, clinical testing , therapeutics, PCR, microarray.

The past few years has seen enormous progress in molecular genetics. Techniques such as Southern blotting, Northern blotting, polymerase chain reaction, nucleotide sequencing, chromosome walking and genetic transfer allow the specific isolation, characterization and modification of genetic information (Boerman et al., 2001). Molecular studies allow the laboratory to become predictive. Now statements can be made about events that occur to a patient in the future. This new technology returns results that give an indication that the patient may be at risk for the disease long before it becomes symptomatic disease. 
Molecular pathology is in a state of rapid evolution featuring continuous technology development and new clinical opportunities for drug selection predicting efficiency, toxicity and monitoring disease outcome .Thus major advances are being made in the science of genetics, resulting in increased use of molecular technology in clinical laboratory.

Biotechnology, in all its forms, is the fastest-growing discipline in the modern laboratory, whether be it clinical, research or forensic (Jain, 2002). The volume of research from the past is translating to a growing list of new diagnostic tests for the patient oriented clinical laboratory. Optimists have characterized these developments as "mankind about to determine its destiny," whereas others are afraid that scientists are about to "start playing God." 
Molecular biology has revolutionized biological and biomedical research and has become an indispensable tool in clinical diagnostics. It has developed more than any other science in the last ten years. Until this time, the laboratory had been descriptive in nature. It could measure events that were currently going on by evaluating the chemistry, hematology or anatomical pathology. 
Major advances are being made in the science of genetics, resulting in the increased use of molecular technology in the clinical laboratory. A wide variety of drugs in late preclinical and clinical development are being targeted to disease specific gene and protein defects that will require co-approval of diagnostics and therapeutics products by regulating agencies . An increasingly educated public will demand more information about their predisposition for serious diseases, how these potential illnesses can be detected in an early stage, when they can be arrested or cured with new therapies custom-designed for their individual clinical status. To respond to this demand, major pharmaceutical companies will form partnerships with diagnostics companies or develop their own in-house capabilities that will permit efficient production of more effective and less toxic integrated personalized medicine drug and test products. For clinical laboratories and pathologists, this integration of diagnostics and therapeutics represents a major new opportunity to emerge as leaders of the new medicine, guiding the selection, dosage, route of administration, and multidrug combinations and producing increased efficacy and reduced toxicity of pharmaceutical products.