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New to Insight Pharma Reports is Molecular Biomarkers for Cancer Detection and Management: Technologies, Markets, and Trends. This report focuses on recent progress and new directions in this highly dynamic diagnostic field. Covering extensive background and history, commercialization, and marketing trends of cancer biomarker technologies, this report provides heavy detail of historical and evolutionary aspects of cancer biomarkers, delineating some of the difficulties researchers face in validating and commercializing their candidate assays.

Significant highlights of the report include:

• Basic research conducted in both academic and commercial settings divided into three segments: disease detection, prognosis, and companion diagnostics.
- 42 detailed descriptions of copmanies (including GenomeDx Biosciences, Genomic Health, Life Technologies, Foundation Medicine, Roche Molecular Systems, and many more!).
• Commercial activity in the three foregoing sectors, and the perspective of market dynamics.
• Focuses on trends and conclusions.
• Data depicted across 15 tables and figures.

Following company descriptions and commercial applications are transcribed interviews of five individuals who are highly knowledgeable in the field, including:

• Genome Diagnostics
• Billings Clinic
• Scientia Advisors
• Cynvenio Biosystems
• Johns Hopkins University School of Medicine

Also provided in the report are survey results of 107 individuals who actively work in the cancer biomarker space. Results are depicted across 9 tables.

Table Of Contents

Molecular Biomarkers for Cancer Detection and Management
Table of Contents

Executive Summary
• Background and history
• Basic research
• Commercial applications
• Market dynamics
• Survey results
• Trends and conclusions

CHAPTER 1: Introduction
• Scope and contents

CHAPTER 2: Background and History
• First-generation cancer biomarkers
• Categorization of cancer biomarkers
• Disease detection biomarkers
• Prognostic biomarkers
• Companion diagnostic biomarkers
• Omic era cancer biomarkers
• Failed efforts and stumbling blocks

CHAPTER 3: Basic Research
• Screening, detection, risk, and monitoring
• Screening
• Prognosis and prediction
• Companion Diagnostics
• Metastasis
• Circulating tumor cells
• Exosomes
• MicroRNA (miRNA)

CHAPTER 4: Commercial Applications
• Screening, detection, risk assessment, and monitoring biomarkers
• Alere
• Allegro Diagnostics
• Atossa Genetics
• Biophysical Corporation
• Exact Sciences
• Exosome Diagnostics
• Matrix-Bio
• MDx Health
• Mitomics
• Myriad Genetics
• Oncimmune
• Onconome
• Predictive Biosciences
• Sphingotec
• Prognosis and prediction biomarkers
• Agendia
• Abbott Molecular
• Atossa Genetics
• Biocept
• bioTheranostics
• DiagnoCure
• GenomeDx Biosciences
• Genomic Health
• Gen-Probe
• Life Technologies
• MetaStat
• Predictive Biosciences
• Skyline Diagnostics
• Trovagene
• Veridex
• Companion diagnostic biomarkers
• 20/20 GeneSystems
• Abbott Molecular
• Cynvenio
• Dako (Agilent)
• Epic Sciences
• Foundation Medicine
• Genomic Health
• Molecular Response Corp.
• Nodality
• Personal Genome Diagnostics
• Interview with founder, Luis Diaz, MD
• Qiagen
• Roche Molecular Systems

CHAPTER 5: Market Dynamics
• Competitive Environment
• Sales Estimates and Projections
• Mergers and acquisitions
• Cancer detection, risk, and prognostic assay deals
• Liquid Biopsy AB and Roche
• Oxford Gene Technology
• Abbott and Stanford University
• Ipsogen and Personal Genome Diagnostics (PDGx)
• Companion diagnostic assay deals
• Abbott and Merck
• Affymetrix and Massachusetts General Hospital (MGH)
• Agilent/Dako and Genentech
• Eli Lilly
• Foundation Medicine
• GE Healthcare and Insight Genetics
• Genomic Health and OncoMed Pharmaceuticals
• HTG Molecular Diagnostics and Merck
• Life Technologies and Others
• Qiagen and Boehringer Ingelheim
• Quintiles and Oxford Cancer Biomarkers
• Roche/Ventana and other companies
• Verastem and Labcorp
• Survey Results

CHAPTER 6: Observations and Conclusions
• Companion diagnostics
• Circulating tumor cells and nucleic acids
• EMT biomarkers
• Tumor Heterogeneity
• Costs and reimbursement

CHAPTER 7: Interview Transcripts
• Luis Diaz, MD, Associate Professor of Oncology, Johns Hopkins School of Medicine; Chief Medical Officer and Founder Personal Genome Diagnostics
• Jorge Nieva, MD, Oncologist and Hematologist,Billings Clinic,Billings Montana
• Harry Glorikian, Managing Partner and Founder, Scientia Advisors
• Paul Dempsey, Ph.D., Chief Science Officer, CynvenioBiosystems
• Scott Kern, M.D., Professor of Oncology and Pathology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine
• About Cambridge Healthtech Institute


• Exhibit 4.1 Screening, detection, risk, and monitoring biomarkers
• Exhibit 4.2 Prognosis and prediction biomarkers
• Exhibit 4.3 Companion diagnostic biomarkers
• Exhibit 5.1 Estimated cancer biomarker manufacturer revenues (2012) and projections (2017), by segment (US$ in billions)
• Exhibit 5.2 Selected recent cancer detection, risk, and prognostic assay deals
• Exhibit 5.3 Selected recent companion diagnostic assay deals
• Exhibit 5.4 Survey: Area of respondents' work
• Exhibit 5.5 Survey: Nature of respondents' organization
• Exhibit 5.6 Survey: Respondents' position within their organization
• Exhibit 5.7 Survey: Respondent's biomarker focus (Multiple answers permitted; n=107)
• Exhibit 5.8 Survey: Respondents' organization employs which of the following technologies for cancer biomarker detection of measurement (Multiple answers permitted; n=100)
• Exhibit 5.9 Survey: Statements regarding circulating tumor cells and nucleic acids (Multiple answers permitted; n=100)
• Exhibit 5.10 Survey: Participation in companion diagnostics (Multiple answers permitted; n=100)
• Exhibit 5.11 Survey: On a scale of 1 to 5, please rate the following entities as likely sources for new cancer biomarkers during the next five years (1=Highly unlikely; 5=Highly likely)
• Exhibit 5.12 Survey: On a scale of 1 to 5, please rate the following technologies as likely means for detecting or measuring cancer biomarkers during the next five years (1=Highly unlikely; 5=Highly likely)


• Figure 4.1 Cynvenio's LiquidBiopsy Platform

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