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Molecular Diagnostics: Technological Advances Fueling Market Expansion

November 10, 2003/Newton Upper Falls, MA/The molecular diagnostics field is in the midst of an exciting era of rapid, continuous growth, driven by an explosion in biomarker research, new applications for these tests, and the growing interest of pharmaceutical companies in developing tests that can be used to guide prescribing. Molecular Diagnostics: Technological Advances Fueling Market Expansion is a new Cambridge Healthtech report that analyzes the trends and developments influencing this marketplace, and identifies the key challenges and areas of opportunity for companies competing in or contemplating moving into this growing field.

A Burgeoning Market

The emergence of molecular diagnostics is arguably one of the most important developments in the field over the past 25 years because it has proven to be both a replacement technology and an enabling technology. Looking toward the future, molecular diagnostics promises to transform disease diagnosis as we know it today. Diagnosis based on symptoms and use of surrogate markers will be replaced by genomic and proteomic analysis. This fundamental shift offers the promise for early disease detection, potentially before symptoms have even occurred. Further, the ability to perform genotypic and proteomic studies using molecular diagnostic tools will result in more effective treatment that is highly targeted to a patient’s specific condition and, at the same time, incurs less risk of adverse drug reactions.

“Molecular diagnostic testing represents a tremendous business opportunity,” states Jorge A. Leon, President of Leomics Consulting, and one of many experts interviewed for the CHI report. “Every company that intends to grow must start applying pharmacogenomics to development of clinical products. You will see the main players (i.e., Abbott, Roche, J&J, Bayer, Becton Dickinson; and probably some of the medium-sized players such bioMérieux and Bio-Rad) join very soon. Roche has already announced they are developing pharmacogenomic diagnostic tools using Affymetrix chips. All the players will eventually offer products for pharmacogenomics testing. The major issue is how they will compete and who will win.”

Critical Issues for Molecular Diagnostics

While molecular diagnostics represents a rapidly growing area of opportunity, significant barriers to widespread adoption of molecular diagnostic testing exist, including reimbursement issues, education and awareness of the clinical utility of a test, the inability to fully interpret test data, and the fact that gene patents are preventing widespread adoption of the tests by routine clinical laboratories.

Bernice A. Allitto, Site Director, Molecular Genetics Laboratory at Genzyme Genetics and another expert contributor to the CHI report, comments. “The challenge going forward is both understanding and learning how to address the implications of molecular genetic testing results. For example, a negative result isn’t always black and white—it doesn’t mean the individual has no risk of carrying or being affected by a genetic disease; it means that person may have a lower risk. It is essential that health professionals appropriately communicate these results to patients.”

Click title to purchase:

Molecular Diagnostics: Technological Advances Fueling Market Expansion