The Future of In Vitro and In Vivo Diagnostic Integration

Report Summary

The term in-vitro/in-vivo diagnostics (IV2D) describes the integration of molecular diagnostics with radiology and pathology (imaging), as well as new software and IT platforms. The aims of this integration are to improve patient care. This report provides an overview of current developments in integrated medical diagnostics, covering the emergence of new IV2D methods that combine IVD with current and developing imaging platforms. The drivers of this integration are reviewed including new disease biomarkers, single, combined and emerging imaging systems, as well as IT and patient-centred systems.

Scope of this research

• Assess the key technologies that will enable in vivo, in vitro diagnostic integration.
• Understand how IVD methods, biomarkers and imaging methods have been applied to challenges of diagnosis in breast cancer and Alzheimer’s disease.
• Discover how centres of expertise, such as academic departments, are driving new discoveries and offering valuable alliances to diagnostic companies.
• Understand the factors that are driving healthcare providers to develop improved healthcare programmes through integration in medical diagnostics.

Research and analysis highlights

Today, diagnosis and treatment are increasingly integrated. This reflects developments in several key areas: scientific, diagnosis, evidence-based therapies, advancing personalized care and improved process efficiency. The need to improve patient diagnosis is today driving healthcare providers to improve management and process efficiency.

The rapidly evolving IV2D field offers important opportunities to diagnostic imaging companies. While imaging continues to see important refinements, the development of new imaging systems is challenging. In contrast, substantial numbers of in-vivo biomarkers are being discovered, offering combined “hybrid” integrations with imaging.

Siemens is a global provider of medical diagnostic systems, incorporating primary tests and instrumentation, IT platforms and software solutions, for clinical data handling and processing. Siemens is also developing technologies in the field of integrated diagnostics.

Key reasons to purchase this research

• What are the major imaging systems in diagnosis and how are they being applied to diagnosis in breast cancer and Alzheimer’s disease?
• What are the business models of some of the major diagnostic companies as they establish new integrated diagnostic and healthcare capabilities?
• What levels of support and capability do healthcare providers seek from companies offering products and services in the fields of diagnostics?
• What strategies are the major diagnostic companies taking to reduce costs of the healthcare products and services?
• Why is it anticipated that the next decade will see substantial growth in the integrated diagnostics field?

Table of Contents

About the author 2
Disclaimer 2
Executive summary 9
The diagnostic-centric healthcare delivery model 9
IV2D Enabling Technologies 10
IV2D Initiatives at Academic Medical Centers 11
Siemens – Medical Diagnostics and Service Model 12
GE Healthcare’s Early Health Model 13
Other Imaging Companies Entering the IVD Market 14
Development Perspectives and Market Outlook 15

Chapter 1 The Diagnostic-Centric Healthcare Delivery Model 16
Summary 16
Introduction 17
Integrated diagnostics 18
Biomarkers 21
Breast cancer 21
Challenges in developing biomarkers 27

Chapter 2 IV2D Enabling Technologies 28
Summary 28
Introduction 29
Neurodegenerative disease 29
Alzheimer’s disease 29
Computed tomography 30
Magnetic resonance imaging 31
Positron emission tomography 33
Parkinson’s disease 34
Functional imaging agents for Parkinson’s disease 35
Functional magnetic resonance imaging in Parkinson’s disease 36
Cancer 37
Mapping HER-2 positive cells 37
11C-choline PET/CT 37
Dual labels 38
Insulin-like growth factor 38
Cardiovascular disease 39
Traponin/CT Angiography 39
Conclusions 40

Chapter 3 IV2D Initiatives at Academic Medical Centers 41
Summary 41
Introduction 42
The Comprehensive Cancer Imaging Centre, London 43
Centre for Molecular Imaging, Australia 46
The Mayo Clinic, US 48
Conclusions 49

Chapter 4 Siemens – Medical diagnostics and service model 51
Summary 51
Introduction 52
Disease areas 52
Cardiovascular 53
Cardiovascular clinical chemistry 54
Cardiovascular immunoassays 55
Haemostasis 56
Integrated diagnostics and point of care 57
Oncology 58
Siemens’ technologies 61
Diagnostics IT 61
Laboratory information 62
Productivity systems 63
Decision support systems 64
Remote monitoring systems 64
eCommerce 64
Siemens information technology 65
Soarian Clinicals 65
Soarian Financials 65
Siemens molecular diagnostic assays 66
Integrated diagnostics 67
The customer’s perspective 70
2009 Molecular Summit, Philadelphia, USA 2009 71
Susquehanna Health 73
Conclusions 73

Chapter 5 GE Healthcare’s early health model 75
Summary 75
Introduction 76
Early healthcare 76
“Healthymagination” 78
Digital imaging 79
Omnyx Integrated Digital Pathology solution (IDP) 80
GE and Eli Lilly 81
GE and VirtualScopics 82
GE and Merck 82
GE acquires Orbitech 83
The PredictAD Project 83
GE and Clarient 84
GE and ONI Medical Systems 84
Conclusions 84

Chapter 6 Other imaging companies entering the IVD market 86
Summary 86
Introduction 87
Philips Healthcare and Biomerieux 87
HistoRx 89
Bayer Schering Pharma 89
Imaging Diagnostic Systems 91
Given Imaging 92
AION Diagnostics 93

Chapter 7 Development Perspectives and Market Outlook 94
Summary 94
Introduction 95
Integrated diagnostics 96
Emerging developments 98
Breast cancer biomarkers 98
Breast cancer predisposition 100
Detection of breast cancer 101
Diagnosis of breast cancer 102
Metastatic breast cancer 104
Response to therapy 105
Prognosis 106
Alzheimer’s disease 107
Prediction of AD 108
Detection of AD 110
Imaged-based biomarkers in AD 112
Market forecasts 116
Biomarkers and risks 118
Driving changes 119
Bibliography 121

List of Figures

Figure 1: The drivers shaping integration in medical diagnostics 18
Figure 2: Biomarkers with utility in the detection, diagnosis and treatment of breast cancer 22
Figure 3: Sources of biomarkers reported with utility in the detection, diagnosis and treatment of breast cancer 23
Figure 4: Types of biomarkers with utility in the detection or diagnosis of breast cancer 24
Figure 5: Single and multiple biomarkers in breast cancer 25
Figure 6: Use of [18F]fluorothymidine (18F-FLT)PET in breast cancer 45
Figure 7: Siemens medical diagnostic IT systems 62
Figure 8: Siemens diagnostic systems organizational structure 67
Figure 9: Siemens diagnostic IT organizational structure 68
Figure 10: Siemens diagnostic detection systems 69
Figure 11: GE’s Vscan Visualization Tool 79
Figure 12: Omnyx Integrated Digital Pathology solution (IDP) 81
Figure 13: The Magnotech principle 88
Figure 14: Required capabilities of integrated diagnostic technologies 97
Figure 15: Sources of biomarkers with utility in the detection or diagnosis of breast cancer 99
Figure 16: Types of biomarkers with utility in the detection or diagnosis of breast cancer 100

List of Table

Table 1: Breast cancer biomarkers indicated for use in the clinic by the American Society of Clinical Oncology (ASCO) 26
Table 2: Siemens dedicated clinical chemistry systems for cardiovascular disease 54
Table 3: Siemens immunoassays for cardiovascular disease 55
Table 4: Siemens haemostasis assays for cardiovascular disease 56
Table 5: Siemens integrated diagnostic systems for cardiovascular disease 57
Table 6: Siemens point-of-care diagnostics for cardiovascular disease 58
Table 7: Siemens diagnostic detection systems 70
Table 8: GE core healthcare capabilities 77
Table 9: Worldwide In vitro diagnostic sales by country 2009-2015, ($bn) 116
Table 10: Worldwide In vitro diagnostic sales by application 2009-2015, ($bn) 117