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Biomarkers - Promising Research, Potential Applications and New Developments
Frost & Sullivan, Sep 2004
Mapping of the Human Genome Leads to Discovery of New Biomarkers
Remarkable progress has been made by the Human Genome Project (HGP) in mapping the human genome and identifying key genes that play a major role in regulating the normal functioning of the human body. About 30,000 genes have been identified so far. After the successful mapping of the genome, the research focus is now shifting to understand the products of gene expression i.e. proteins. This shift in focus can be attributed to the realization of the fact that proteins and not genes are responsible for performing most life functions. Currently, scientists are striving to find proteins (biomarkers) that are specific to various disorders. More and more biomarkers are being identified with the help of sophisticated enabling instruments and technologies such as mass spectrometers and protein microarrays. These novel biomarkers are likely to aid researchers in developing precise clinical diagnostics and drugs that are capable of detecting and curing fatal diseases.
Frost & Sullivan’s recent study focuses on the key research advancements and product development in enabling technologies that assist in discovery of biomarkers. The research discusses the application of biomarkers in drug discovery, clinical diagnostics, and personalized medicine. It also provides detailed information on end users and key participants that are in the forefront of technology development and commercialization.
Biomarker-based Screening Tests Gain Acceptance Despite Shortcomings
The early detection and diagnosis of fatal diseases - particularly cancer, Alzheimer’s, and Parkinson’s - enhances the prospects of curing the affected patients. This would encourage physicians to recommend patients to undertake biomarker-based screening tests that can predict these deadly diseases in the early stages. These tests are also likely to help physicians in prescribing personalized medication to patients after pinpointing the particular pathway that is playing an active role in the disease progression. This would not only lead to reduction in side-effects but also ensure that patients are adminstered the right medication.
Impressed by such overwhelming benefits, health insurance companies may insist that their customers undertake biomarkers-based screening tests, as these tests are expected to help them avoid spending on ineffective therapies and reduce expenditure. However, sensitivity and specificity of these tests is a major challenge that has to be overcome if they are to gain prominence. Developing diagnostic and screening tests that employ multiple biomarkers rather than relying on tests with a solo biomarker is one possible solution to this problem, says the analyst.
Biomarkers Enhance Success Rate in Drug Discovery
Biomarkers are extremely useful in screening, identifying, and developing drugs or other suitable interventions for several kinds of diseases. A high failure rate of potential drugs is currently driving research on the identification of biomarkers that are likely to act as surrogate primary end points in clinical trials for predicting drug efficacy in animals and humans. Biomarkers not only help in selecting suitable patients to participate in the clinical trials but also enable toxicity profiling, says the analyst. By reviewing the drugs’ toxicity profile by employing biomarkers, pharmaceuticals companies can retain or drop the drug at the initial stage of development itself, and thereby, avoid spending precious resources on drug candidates that may prove to be unviable at a later stage of drug development.
The shift in focus from discovering genomic biomarkers to protein biomarkers is driving demand for robust research instruments that enable multiplexing and reduce manual steps such as sample preparation. Technological developments in terms of automation and increase in throughput are enabling researchers to solve the riddle of the human proteome - which is much more complex than the human genome. Companies that manufacture protein chips containing high-density arrays of functional proteins and microfluidics-based platforms are likely to cash in on these novel research efforts aimed at discovering new biomarkers.
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