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Recent Advances in the Fast-Growing Molecular Diagnostics Industry

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Overview:
Molecular diagnostics (MDx) is becoming increasingly entwined with the development of pharmaceutical drugs. Initially, it was used in clinical settings to aid diagnosis, prognosis, and optimal treatment, but now, backed by regulatory authorities, it is becoming important in the development and commercialization of new and existing therapies. As a result, the MDx industry, already a multibillion-dollar market, will continue to expand at a significant pace.

The MDx market can be segmented into three phases: infectious diseases; blood screening; and pharmacogenomic testing, genetic testing, predictive testing, and companion diagnostics. Why does scope for greater innovation and greater sales potential lie in the third phase?

According to industry experts, polymerase chain reaction (PCR) technology will have the greatest impact on the MDx market. PCR enables researchers to amplify minute amounts of genetic material to billions of copies in a matter of hours through repeated cycles of duplication via the use of an enzyme called DNA polymerase or Taq polymerase. What big pharma company used PCR to become one of the most powerful leaders in the field of MDx?

Pharmaceutical companies have traditionally been reluctant to employ MDx (e.g., to identify biomarkers) to screen drug candidates during the R&D process for fear of reducing the potential target population. Why is this attitude changing?

Big pharmaceutical companies and smaller MDx companies are teaming up to produce MDx technologies. What alliances have been formed, and what products have been the result?nificant pace.
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By Dr Cheryl Lee Barton / Publication Date: 16th March 2007

Contents:

Contents
Executive Summary 3
Strategic Considerations 3
Stakeholder Implications 3
Overview 4
The Evolution of the MDx Industry 4
The Three Phases of the MDx Industry 5
Phase One: Infectious Diseases 5
Phase Two: Blood Screening 6
Phase Three: Pharmacogenomic Testing, Genetic Testing, Predictive Testing, and
Companion Diagnostics 6
Pharmacogenomic Testing 7
Predictive Testing 10
Genetic Testing 11
Expert Commentary–MDx: Looking Ahead 12
Companion Diagnostics 14
MDx Technologies and Platforms 14
MDx Technologies 14
PCR 14
DNA Methylation 15
RNA Interference 17
MDx Platforms 17
Microarrays and Nanoarrays 17
Microfl uidics 18
Multiplex Assays 18
Changing Trends 18
Pharmaceutical/MDx Alliances and Acquisitions 18
Support from Regulatory Authorities 19
Alliances Between Diagnostics and Technology-Based Companies 19
Regulatory Environment and Advances in MDx 20
Key Players in the MDx Field 21
Roche Diagnostics 21
Abbott Diagnostics 21
Bayer Diagnostics/Siemens Medical Solutions Group 22
Market Outlook 23

List of Tables:

Tables:
1. Select Molecular Diagnostics for Infectious Agents 6
2. The Third Phase of the MDx Industry 7
3. Recent Alliances Between Research Organizations and Pharmaceutical/Biotech
Companies 8
4. AmpliChip CYP450 Test 10
5. Select PGx-Based Diagnostic Tests 11
6. Comparison of Molecular Tests 16
7. Select Pharma-Diagnostics Industry Alliances 21
8. Recent Alliances Between Diagnostic and Technology Companies 22
9. Key Mergers and Acquisitions in the MDx Market 23
10. Likely Impact of Increased Uptake of MDx Tests 25
11. Global Market Opportunities for Molecular Diagnostics, 2005-2010 26
A. Current and Planned MDx Products at Celera Diagnostics 12

Figures:
1. The Three Phases of the Molecular Diagnostic Industry 5
2. Growth in Alliances Between Academia/Research Organizations and Pharmaceutical/Biotech
Companies, 2002-2006 10
3. Select Molecular Diagnostic Technologies and Platforms 15
4. Interrelationship Between Pharmaceutical/Biotech and Molecular Diagnostics Companies 19
5. Future Diversifi cation of the MDx Market 26


 

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