This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.
Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy.
This report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation.
The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer.
Key Topics Covered:
2. Introduction to Molecular Diagnostics
2.1 Opening of Opportunities in Molecular Diagnostics
2.2 Impact of the Human Genome Project on Molecular Diagnostics
2.3 Considerations for Molecular and Clinical Diagnostics
2.4 Molecular Diagnostics in the Post-Genomic Era
2.5 Advances in Molecular Diagnostics Technologies
2.6 Oligonucleotide Array Platforms
2.7 Emerging Cancer Personalized Medicine Market
2.8 Companion Diagnostics
2.9 Opportunities for Molecular Diagnostic Companies
2.10 Liquid Biopsies
2.11 Data Analysis
2.12 In-house vs. Commercial Testing
2.13 Multi-Gene Cancer Panels
3. Cancer Diagnostics Molecular Testing Market
3.1 Market Description
4. Molecular Diagnostic Tests for Cancer
4.1 Overview of Molecular Diagnostics for Cancer
4.2 Breast Cancer Molecular Diagnostics
4.3 Colorectal Cancer Molecular Diagnostics Market
4.4 Prostate Cancer Molecular Diagnostics Market
4.5 Ovarian Cancer
4.6 Lung Cancer
4.8 Molecular Diagnostic Assays for Other Types of Cancers
4.9 Panels Testing Multiple Cancers
4.10 Potential new Entrants to the Market
5.1 Technology and Market Trends
5.2 M&A Activity
5.4 Summary of Market Strengths, Weaknesses, Opportunities and Threats
5.5 Intellectual Property Rights
6. Reimbursement and Billing
6.2 Trends in Reimbursement Practice
6.3 Trends in Patient Care and Reimbursement
6.4 Revenue Threats
7. Government Regulation
7.1 U.S. Food and Drug Administration
7.2 CLIA Regulations
7.3 Clinical Laboratory Improvement Act
7.4 State Licensing for Service Laboratories
7.5 510(k) Clearance
7.6 Pre-Market Approval
7.8 What Regulatory Guidance is Needed for Companion Biomarkers?
7.9 U.S. Patent and Trademark Office
7.10 IRB Approval in Clinical Trials
7.11 Microarray Quality Control
7.12 ER and PR Proficiency Testing
8. Company Profiles
- Bioreference Labs
- Cancer Genetics, Inc.
- Dako (an Agilent Technologies company)
- Exact Sciences Corporation
- Flatiron Health
- Fulgent Diagnostics
- Genomic Health, Inc.
- Genoptix, Inc. (Novartis)
- HTG Molecular Diagnostics
- Guardant Health
- Myriad Genetics, Inc.
- Nuvera Biosciences
- Orion Genomics
- Pathway Genomics
- Quest Diagnostics
- Roche Molecular Systems
- Rosetta Genomics Ltd.
- Sophia Genetics
For more information about this report visit http://www.researchandmarkets.com/research/g6p6rm/molecular