Advancements in Genomics and Proteomics Broaden the Role of Biomarkers in Healthcare.

PALO ALTO, Calif. -- Having successfully deciphered the human genome, researchers are now shifting focus to solve the riddle of human proteome - that is proteins - the ultimate product of gene expression. This, in turn, is aiding the discovery of protein-based biomarkers that are expected to play a major role in drug discovery, molecular diagnostics, and personalized medicine.

"Interpreting proteomics is likely to be a daunting task as proteins are more complex than nucleic acids," says Technical Insights Analyst S. Ravi Shankar. "Hence, technologies and instruments used for these experiments should be capable of adapting to the higher complexity and fragility of the human proteome."

High levels of technological advancements are already visible across instruments - such as mass spectrometers, microarrays, and 2D gel electrophoresis equipment to name a few - that are used in detecting protein-based biomarkers. The resultant increase in throughput and enhanced automation is having a profound impact on the discovery of biomarkers.

More and more biomarkers are being discovered using these sophisticated instruments. This is expected to aid researchers in developing precise clinical diagnostics and drugs that are capable of early detection and/or curing fatal diseases such as cancer, Alzheimer's disease, and Parkinson's disease. Biomarkers would eventually pave the way for personalized medication. Biomarkers would help in targeting the appropriate medicine to the patients, thereby increasing the chances of recovery and reducing the side effects of medications.

However, scientists are presently confronting challenges in terms of resolution and purification of protein mixtures, besides facing difficulties in separating proteins.

"Protein molecules have different structures and chemical properties and also vary with respect to their intracellular abundance in different cell types," says Ravi Shankar. "It is therefore virtually impossible to find an analytical technique that is capable of resolving and separating the thousands of protein forms present in a cell at a given time."

Another significant challenge faced by participants is the stringent regulations set by controlling bodies such as the Food and Drug Administration (FDA) in the United States concerning the validity of biomarkers and approval of drugs or diagnostic tests that are being developed by utilizing them.

Biomarker validation too is a big challenge. Pharmaceuticals companies need to validate the authenticity of biomarker-based drugs/tests. Validation is a costly and time-consuming process and involves testing the drug or diagnostic kit on numerous individuals, before introducing the product in the market.

Biomarkers come to the rescue of pharmaceutical companies by helping them to select suitable patients for participation in clinical trials besides enabling toxicity profiling. "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 development," says Ravi Shankar.

As biomarkers gain in prominence, developers of biomarker-based tests have to ensure that their tests are included in the screening guidelines promulgated by authoritative bodies such as the American Cancer Society or in the Medicare program. Unless this is done, market uptake is likely to be limited as patients are expected to resist spending their own money on these expensive tests.

Concerted efforts are also on to overcome the challenges related to sensitivity and specificity of biomarker-based screening by developing tests that employ multiple biomarkers rather than relying on tests with a solo biomarker.

These efforts, along with the shift in focus from discovering genomic biomarkers to protein biomarkers, are driving demand for robust research instruments that enable multiplexing and reduce manual steps such as sample preparation.

Hence, companies that can develop flexible, low-cost, biochips for gene and protein expression profiling and microfluidics-based platforms are anticipated to reap high returns while providing further momentum to the discovery of new biomarkers and their use in clinical diagnostics and drug development.

Biomarkers: Promising Research, Potential Applications, and New Developments is part of the Technical Insights Healthcare Vertical Industry subscription service. Technical Insights' recent research focuses on the key advancements and product development in enabling technologies that assist in discovery of biomarkers. The study discusses the application of biomarkers in drug discovery, clinical diagnostics, and personalized medicine besides providing detailed information on end users and key participants in the forefront of technology development and commercialization. Executive summaries and interviews are available to the press.

If you are interested in an analysis overview which provides manufacturers, end-users and other industry participants an overview, summary, challenges and latest coverage of Biomarkers: Promising Research, Potential Applications, and New Developments - then send an email to Danielle White - North American Corporate Communications at [e-mail] with the following information: Full name, Company Name, Title, Contact Tel Number, Contact Fax Number, Email. Upon receipt of the above information, an overview will be emailed to you.

Technical Insights is an international technology analysis business that produces a variety of technical news alert, newsletter, and report services.

Frost & Sullivan, an international growth consultancy, has been supporting clients' expansion for more than four decades. Our market expertise covers a broad spectrum of industries, while our portfolio of advisory competencies includes custom strategic consulting, market intelligence, and management training. Our mission is to forge partnerships with our clients' management teams to deliver market insights and to create value and drive growth through innovative approaches. Frost & Sullivan's network of consultants, industry experts, corporate trainers, and support staff spans the globe with offices in every major country.

Biomarkers: Promising Research, Potential Applications, and New Developments D301

Keywords in this release: Genomics, proteomics, biomarkers, healthcare, human genome, human proteome, proteins, gene expression, drug discovery, molecular diagnostics, personalized medicine, nucleic acids, mass spectrometers, microarrays, 2D gel electrophoresis, clinical diagnostics, cancer, Alzheimer's disease, Parkinson's disease, protein mixtures, intracellular abundance, protein forms, FDA, toxicity profiling, screening guidelines, American Cancer Society, Medicare program, multiplexing, sample preparation, biochips, microfluidics-based platforms