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  4. > MicroRNA: An Insight to miRNA-based microarrays, diagnostics and therapeutics Overview, Cambridge Healthtech Advisors

This report covers the specifics of microRNA (miRNA) as it is a relatively new space in heavy pursuit of research due to its versatility and stability, properties that are unique to miRNAs compared to other RNA components. miRNA's non-coding nature and ability to affect genetic expression make it a novel candidate for use as a biomarker for a variety of diseases. This prompted the pursuit of miRNA-based microarrays and diagnostics for the advancement in therapeutic development. Furthermore there are a number of academic laboratories not only validating miRNAs, but also identifying them in a number of diseases and examining their molecular actions in the presence of other molecules. This report is broken up into several parts, highlighting miRNA in several areas of research.

After covering background information, the second and third parts of this report expand upon several microarrays and diagnostics for specific analysis and therapeutic development. Several companies featured in this section include:
• Affymetrix
• Exiqon
• Diamir
• Rosetta Genomics
• Eisai
• miRNA Therapeutics

Chapters within these sections feature company backgrounds and highlight proprietary technologies and platforms. Additionally, several advantages and limitations are also discussed. More significantly, these chapters are accompanied by interviews with company representatives, exclusively conducted for this report.

The fourth part of this report explores the academic, research and community perspectives. Although not developing diagnostics per se, academia is diligently investigating several aspects of miRNAs including their molecular properties for use as biomarkers for neurodegenerative diseases, diabetes, and even cancer. Universities and research institutes included in this area are:
• Stony Brook University School of Medicine
• Grand Valley State University
• Van Andel Research Institute

Also included in these sections are interviews with experts in leading research from these universities. From a community perspective, Dr. Argyropoulos, a Medical Affairs Consultant, provides insight to the rapidly growing space and rising opportunities.

Finally, the report concludes with an in depth analysis of survey results. With 152 researchers, these results provide an overall perspective of the research community, capturing a number of miRNA applications, challenges afloat in the industry, and miRNA mechanisms of study.

Table Of Contents

MicroRNA: An Insight to miRNA-based microarrays, diagnostics and therapeutics Overview, Cambridge Healthtech Advisors
Table of Contents
Executive Summary
Part I: Background and Introduction
CHAPTER 1: What is miRNA?
Gene Expression
Part II: miRNA: Oligonucleotide Synthesis and Microarray Technologies
CHAPTER 2: miRNA Creation and Application
Engineering Oligonucleotides
Photolithographic Synthesis
Engineering miRNA Antagonists: OMe, MOE, and LNA
Other Engineering Methods: miRNA Mimicry
CHAPTER 3: Affymetrix: miRNA Microarrays and Photolithographic Technology
Company Bckground
GeneChip miRNA 4.0 Array
Photolithographic Process and Assay Features
Specificity and Sensitivity
Areas of Improvements and Future Expectations
Interview with Dr. Johanne McGregor
Company Background
GeneChip miRNA 4.0 Array
Targets and Applications
Challenges, Benefits, Improvements, and Future Expectations
CHAPTER 4: Exiqon: Improving miRNA Detection with LNA Technology
Research Background
The Biology of miRNAs as Biomarkers
Locked Nucleic Acid (LNA) Technology
miRCURY LNA qPCR Platform: Advantages and Market Outlook
Interview with Dr. Henrik M. Pfundheller
Research Background
Locked Nucleic Acid (LNA) Technology
microRNA qPCR Platform
Part III: miRNA: Diagnostic and Therapeutic Applications
CHAPTER 5: miRNA Use as Diagnostic Biomarkers
miRNA Diagnostic Applications
CHAPTER 6: Rosetta Genomics
Research and Company Background
microRNA Diagnostic Platforms
Advancements in Healthcare
Areas of Improvement and Limitations
Interview with Ken Berlin
Company Background
microRNA Diagnostic Platforms
Platform Specifications
Advancements in Healthcare
Improvements and Limitations
CHAPTER 7: DiamiR: miRNA Neuro-Diagnostics
Company Background
Universal Screening Test and Specifications
Advantages and Future Outlook
Interview with Kira Sheinerman
Company Background
Platforms and Specifications
Advantages, Limitations, and Future Expectations
CHAPTER 8: Gensignia: miRNA Lung Cancer Diagnostics
Company Background
miRNA Signature Classifier (MSC) Lung Cancer Test
Advancements in Healthcare
Interview with Dr. Elisa Romeo
Company Background
MSC Lung Cancer Test
Advancements in Healthcare
CHAPTER 9: Eisai: miRNA Research and Diagnostics for Alzheimer's Disease
Company Background
miRNAs As Circulating Biomarkers
Eisai's miRNA Research in Alzheimer's Disease
Competitive Strategies
Improvements and Limitations
Future Expectations
Interview with Dr. Pavan Kumar
Company Background
miRNA Research
Competitive Strategies
Future Expectations
Part IV: miRNA Research in Academia: Targets, Diagnostics, and End User Perspectives
CHAPTER 10: miRNAs in Academia: Understanding Molecular Interactions, Diagnostic and Therapeutic Approaches, and Significance of Technology Advancements
CHAPTER 11: Stony Brook University School of Medicine: miRNA in Colorectal Cancer
miRNA in Colorectal Cancer
p53 and miRNA in Colon Cancer
Epithelial-to-Mesenchymal Transition (EMT)
Diagnostic and Therapeutic Applications
Challenges Encountered and Areas of Improvement
Interview with Dr. Jingfang Ju
miRNA Research
miRNA Properties and Technologies
p53 and miRNA
Epithelial-to-Mesenchymal Transition (EMT)
Diagnostics and Therapeutic Applications
Challenges and Areas of Improvement
Future Applications
CHAPTER 12: Grand Valley State University: miRNA in Parkinson's Disease
Circulating miRNA as a Biomarker for Parkinson's Disease
Cerebral Spinal Fluid vs. Plasma
Advantages, Limitations, and Areas of Improvement
Interview with Dr. Sok Kean Khoo
Research Background
Methods and Properties
Areas of Improvement and Challenges
CHAPTER 13: Independent miRNA Research: The Role of miRNAs in Nephrology
Research Background
miRNA in Type 1 Diabetes and Diabetic Kidney Disease
Research Limitations, Challenges, and Areas of Improvement
Future Outlook, Applications and Growth
Interview with Dr. Christos Argyropoulos
Research Background
Challenges, Benefits and Areas of Improvement
Future Outlook and Industry Impact
CHAPTER 14: Van Andel Research Institute: miRNA Discoveries and Technology Advancement
Institution Background
Research Background
miRNA Properties and Discoveries
miRNA Tissue Slide-Based Assays
Advantages of miRNA Tissue Slide-Based Assays
Challenges and Limitations of miRNA Tissue Slide-Based Assays
Areas of Improvement
miRNA Market Outlook
Interview with Dr. Lorenzo Sempere
Research Background
miRNA Properties
Diagnostics and Therapeutics
Limitations and Advantages
Future Expectations
Part V: miRNA Highlights, Challenges, and Advances in RandD
CHAPTER 15: Survey Analysis


Table 3.1: GeneChip miRNA Microarray Version Comparisons
Table 3.2: Instrument Compatibility of GeneChip miRNA 4.0 Array
Table 3.3: Platform Specifications
Table 6.1: Rosetta Genomics Testing Specifications
Table 7.1: Universal Screening Test Specifications
Table 8.1: miRNA Signature Classifier Lung Cancer Test Specifications


Figure 6.1: Product Pipeline and Market Forecast
Figure 15.1. Survey Demographics: Classification of Researchers
Figure 15.2. Research Areas: Pursuing miRNA in Drug Discovery or Assay Development
Figure 15.3. Drug Discovery: Drug Target Status
Figure 15.4. Drug Discovery: The Challenges and Difficulties in Studying miRNA
Figure 15.5. Drug Discovery: Who is Studying What?
Figure 15.6. Drug Discovery: miRNA Mechanisms of Interest
Figure 15.7. Drug Discovery: miRNA Effects of Interest
Figure 15.8. Assay Development: Technological Status
Figure 15.9. Assay Development: Competitive Advantage
Figure 15.10. Assay Development: Challenges Encountered
Figure 15.11. miRNA Therapeutic Market Outlook

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