Comprehensive Coverage of Clinical Applications of First- and Next-Generation Molecular Diagnostics.

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c45830) has announced the addition of "Molecular Diagnostics: Effective Tools for Disease Management, 3rd Edition" to their offering.

Unlike traditional in vitro diagnostics, whose role is largely confined to diagnosis and monitoring of a restricted range of diseases, molecular diagnostics are establishing themselves as effective tools for all aspects of disease management, especially in areas of unmet clinical need. Based on sensitive detection of disease- and often individual-specific biomarkers, such tools provide an opportunity to intercept the disease process early, stratify patients for treatment and/or predict treatment success. Depending on the clinical situation, DNA sequences, DNA methylation patterns, gene expression profiles, proteins, protein expression, or combinations of these, may all be used as biomarkers. The first generation of molecular diagnostics on the market utilize established technology platformsCoimmunoassays and probe-based nucleic acid testing (NAT). While the world market for in vitro diagnostic products (IVDs), as a whole, is forecast to increase from $36.5 billion in 2005 to $53.6 billion in 2010 (AGR of 8.0%), the molecular diagnostic segments analyzed in this report, will significantly outperform the market, growing from $13.8 billion in 2005 to $22.7 billion in 2010 (AGR of 10.4%). Sales of nucleic acid-based tests are expected to grow much more quickly than immunoassays.

Leading manufacturers of immunoassay and nucleic acid testing products include

(in descending order by market share) Roche Diagnostics, Abbott Laboratories, Johnson & Johnson, Beckman Coulter, Bayer Diagnostics, Becton Dickinson, Dade Behring, and bioMerieux. Advances in biomarker detection technologies are examined in this report. Molecular diagnostics increasingly utilize multiplexing platforms such as DNA microarrays that perform parallel biomarker analyses in order to provide more comprehensive clinical information. During the last two years the FDA approved the first DNA microarray instrumentation system for in vitro

diagnostic use (Affymetrix's GeneChip System 3000Dx), and the first highly multiplexed diagnostic microarrays: Roche's AmpliChip CYP450 test and two cystic fibrosis testsCoTm Bioscience's Tag-It and Osmetech's eSensor. Although they have yet been approved by the FDA, tests based on transcriptomic profiling have also debuted successfully on the market.

This report offers a comprehensive coverage of clinical applications of first- and next-generation molecular diagnostics. All major clinical markets are reviewed, with particular emphasis on commercial products recently launched and those under development in the areas of infectious diseases, cardiovascular diseases, and cancer. The infectious diseases field continues to see expanded use of NAT in viral load testing and genotyping, cervical-cancer (HPV) screening, bacterial detection, and screening of blood and blood products. Developments in the cardiovascular field are being driven by the need for reliable cardiovascular risk stratification and

many potential individual biomarkers and panels of biomarkers are under investigation. In the area of cancer particularly rapid advances have been made in recent years in proteomic and transcriptional profiling; these approaches have begun to radically alter the way cancer is diagnosed, classified and treated.

A survey was carried out for this report to identify US patents and patent applications filed since January 1, 2000 which deal with the molecular diagnostics applications of biomarkers.

The survey yielded 463 documents. Its most striking finding was the considerable R&D activity being devoted to biomarkers of CNS and inflammatory disorders. These do not currently form significant segments of the world IVD market (unless autoimmunity is included).

Molecular Diagnostics: Effective Tools for Disease Management, 3rd Edition market analysis report offers a comprehensive coverage of the scientific and technological developments which are creating new opportunities for the development of improved molecular diagnostics. This information will benefit developers of in vitro diagnostics as well as drug developers. The report analyses significant recent developments in molecular diagnostics which have implications for all developers of in vitro diagnostics and drugs. The first generation of molecular diagnostics on the market analyze protein and DNA biomarkers. New tests and services utilizing protein or DNA biomarkers continue to be launched and these are analyzed in the report.

About the Authors:

Sreten Bogdanovic, Ph.D., and Beata Langlands, Ph.D., are co-founders of Biophoenix, a biomedical consultancy based in the heart of England, UK. Established with support from the UK Department of Trade and Industry (DTI) in 1994, Biophoenix provides detailed, accurate, market and technical information to support decision-making by biotechnology-based enterprises in the healthcare industry. In doing so, Biophoenix relies on its comprehensive in-house bioindustry database and a wide network of contacts. Biophoenix also audits biotechnology-based enterprises with regard to the risk of intellectual property litigation on behalf of several Lloyds of London insurers. Dr Bogdanovic is Managing Partner in Biophoenix. He holds a PhD in endocrinology from Imperial College, UK, and has worked as manager for immunodiagnostics with the UK subsidiary of Boehringer Mannheim (now owned by Roche), and as an independent biomedical market analyst with Cistron, UK. Dr Langlands holds a PhD in biochemistry from the University of Glasgow, UK, and has worked as an immunologist, a project leader with a new biotechnology company based at Warwick University in the UK, and as a university lecturer. Biophoenix has researched and written over 30 in-depth management/market reports.

Topics Covered:

* -Technology Developments

* -Molecular Diagnostics in Infectious Diseases

* -Cardiovascular Diseases

* -Cancer

* -Miscellaneous Diseases and Conditions

* -Patents for Diagnostic use of Biomarkers

* -Market Considerations and Forecasts

* -Company Profiles

* -Trends and Opportunities

For more information visit http://www.researchandmarkets.com/reports/c45830