Author: Ken Rubenstein, PhD
Executive Summary
Technology
Current Molecular Diagnostics Products Spectrum
Infectious Disease
Cancer
Other Disease Categories
Companion Diagnostics
Prognostic/Prediction Testing
Genetic Disease and other Testing
Pharmacogenetic Assays viii
Molecular Diagnostic Products Currently in Development Cancer
Other Disease Areas
Market Dynamics
Conclusions and Observations
CHAPTER 1
Introduction
1.1 Scope and Content of this Report
CHAPTER 2
Technologies for MDx
2.1 Definition of Molecular Diagnostics
2.2 Hybridization without Amplification
2.3 Amplification-based Assays
Target Amplification
Signal Amplification
2.4 Multiplex Assays
2.5 DNA Sequencing-based Assays
2.6 Automation
Technological Milestones
CHAPTER 3
Molecular Diagnostic Products on the Market
3.1 Infectious Disease
Diagnostic Assays
Blood Processing
Point-Of-Care
3.2 Cancer
3.3 Neurology
3.4 Other Assays
3.5 Companion Diagnostics
Cancer
3.6 Prognostic/Predictive Testing
Cancer
3.7 Genetic Disease Testing
Cystic Fibrosis
Other Conditions
3.8 Pharmacogenetic Assays
CHAPTER 4
MDx Products in Development
4.1 Infectious Disease
Diagnostic
Point-Of-Care Infectious Disease Testing
4.2 Cancer
4.3 Other Diseases and Conditions
CHAPTER 5
Market Dynamics
5.1 Market Overview
5.2 Key Market-Related Challenges
Regulatory
Reimbursement
Assay Validation
Impact of Predictive/Prognostic Testing
Automation
Point-Of-Care
Companion Diagnostics
Intellectual Property
5.3 Deal Activity
CHAPTER 6
Conclusions and Observations
6.1 Molecular Diagnostics: Approaching Maturity or Still in Adolescence?
6.2 Some Old-Line Diagnostics Companies May Miss the Boat
6.3 FDA and LDTs: Solomon-like Solution or Party Over?
6.4 Small Companies Caught in a Funding Bind
6.5 Point-Of-Care MDx is Coming On Strong
6.6 The Coming Age of Next-Gen Sequencing-based MDx
6.7 General Observations
CHAPTER 7
Interview Transcripts
7.1 Bill Coty, BioDx Partners, LLC, Chief Scientific Officer
7.2 Stephen Naylor, Maihealth, Chairman and President
7.3 Harry Glorikian, Scientia Advisors, Founder and Managing Partner
7.4 Lyle Arnold, Aegea Biotechnologies, President and Founder
7.5 Brian Caplin, Ph.D., Signal Diagnostics, President, CEO, and Chief Scientific Officer
7.6 Tom Adams, Sr., Chief Technology Officer and Director, IRIS International
Company Index
References
About Cambridge Healthtech Institute