Molecular Diagnostics in Cancer Testing

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Apr 09, 2014, 01:59 ET

DUBLIN, April 9, 2014 /PRNewswire/ --

Dublin - Research and Markets (http://www.researchandmarkets.com/research/k3xnm6/molecular) has announced the addition of the "Molecular Diagnostics in Cancer Testing" report to their offering.

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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. 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.

Key Topics Covered:

1. Overview

2. Introduction to Molecular Diagnostics

3. Cancer Diagnostics Molecular Testing Market

4. Molecular Diagnostic Tests for Cancer
4.1 Cancer Diagnostic Tests
4.2 Breast Cancer
4.3 Colorectal Cancer Molecular Diagnostics Market
4.4 Prostate Cancer Molecular Diagnostics Market
4.5 Other Cancer Molecular Diagnostic Markets
4.6 Molecular Diagnostic Screening Test for Cancer
4.7 Companion Diagnostic Tests for Cancer Therapeutics

5. Business
5.1 Technology and Market Trends
5.2 M&A Activity
5.3 Partnerships
5.4 Competitive Analysis
5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing
5.6 Intellectual Property Rights

6. Reimbursement and Billing
6.1 Overview
6.2 Trends in Reimbursement Practice
6.3 Breast Cancer Tests
6.4 Colon Cancer Tests
6.5 Trends in Patient Care and Reimbursement
6.6 Revenue Threats
6.7 Billing

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 FDA Treatment of Multivariate Index Assays
7.6 510(k) Clearance
7.7 Pre-Market Approval
7.8 ASRs
7.9 What Regulatory Guidance is Needed for Companion Biomarkers?
7.10 U.S. Patent and Trademark Office
7.11 IRB Approval in Clinical Trials
7.12 Oncology Biomarkers Qualification Initiative Project
7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX
7.14 FDA Packaging Requirements for Erbitux
7.15 Microarray Quality Control
7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR Testing
7.17 ER and PR Proficiency Testing

8. Business Decisions Using Molecular Diagnostic Tests in Cancer Test Development

9. Company Profiles

Companies Mentioned: