New to Insight Pharma Reports is Digital Pathology Insights:  Imaging Technologies, Expert Perspectives, Standardization, and Current Outlooks. This report delves into the rapidly evolving field of digital pathology, briefly reviewing the underlying scientific and technological concepts and providing an insightful perspective on various factors thought to be of significance to the development and future of this space.

Broken into several sections, the beginning of this report provides an overview of digital pathology including:

• Terminology and definitions
• Types of digital imaging systems (including whole slide scanners)
• Technical underpinnings
• Current and emerging applications

A brief overview of the digital pathology market will cover identified drivers and obstacles as well as current forecasts. The FDA and several standards organizations are profiled with regard to activities that may impact the furtherance of this field.  Included in this section is an exclusive interview with Craig Revie, Chair of the International Color Consortium’s Medical Imaging Working Group and project coordinator for the development of a calibration system for digital microscopes.

Updated with all new interview with Thomas W. Bauer MD, PhD Medical Director for ePathology Medical Director, Cleveland Clinic Central Biorepository Departments of Pathology, Orthopedic Surgery and The Spine Center, Cleveland Clinic discussing Whole Slide Imaging Repository.

Companies featured in this report include:

• 3DHISTECH
• Applied Spectral Imaging
• Carl Zeiss Microscopy GmbH
• DigiPath Corp
• FFEI Ltd.
• Huron Technologies
• Nikon Instruments
• PerkinElmer
• Philips Digital Pathology Solutions

These companies have provided valuable insights as to the evolution of digital pathology within their businesses, the details of their current imaging systems, strategies, and techniques, as well as their individual perspectives on the establishment of standards in digital pathology, the challenges the field may face and the benefits that await as a digital environment becomes commonplace in pathology. Interviews with the expert company representatives are also included.

Finally, the report concludes with a unique look at the current climate of the digital pathology space based on a survey conducted by Insight Pharma Reports which polled a group of individuals identified as end users or developers of digital pathology technologies. An in depth analysis of these results compares the perspectives of both demographics on several important topics revealing areas of commonality and also divergence. Topics include areas most in need of improvement and the challenges and benefits associated with the use and development of digital pathology technologies.

Executive Summary

Digital Pathology Insights: Imaging Technologies, Expert Perspectives, Standardization, and Current Outlooks delves into the rapidly evolving field of digital pathology, briefly reviewing the underlying scientific and technological concepts and providing an insightful perspective on various factors thought to be of significance to the development and future of this space.

The opening chapters will provide an overview of digital pathology including: terminology and definitions for the purposes of this report, types of digital imaging systems (including whole slide scanners), and their technical underpinnings as well as current and emerging applications. A brief overview of the digital pathology market will cover identified drivers and obstacles as well as current forecasts. The U.S. Food and Drug Administration and several standards organizations will be profiled with regard to activities that may impact the furtherance of this field. Included in this section is an interview with Craig Revie, Chair of the International Color Consortium’s Medical Imaging Working Group and project coordinator for the development of a calibration system for digital microscopes.

Participating companies, including 3DHISTECH, Applied Spectral Imaging, Carl Zeiss Microscopy GmbH, DigiPath Corp., FFEI Ltd., Huron Technologies, Nikon Instruments, PerkinElmer, and Philips Digital Pathology Solutions, have provided valuable insight as to the evolution of digital pathology within their businesses, the details of their current imaging systems, strategies, and techniques, as well as their individual perspectives on the establishment of standards in digital pathology, the challenges the field may face, and the benefits that await as a digital environment becomes commonplace in pathology. Interviews with the experts from the participating companies are also featured.

The report concludes with a unique look at the current climate of the digital pathology space based on a survey conducted by Insight Pharma Reports which polled a group of individuals identified as end users or developers of digital pathology technologies. Review of these results compares the perspectives of both demographics on several important topics revealing areas of commonality and also divergence. Topics include aspects of the technology that are in most need of improvement, and the challenges and benefits associated with the use and development of digital pathology technologies.

Table of Contents

Executive Summary

Part 1: An Introduction to Digital Pathology

Chapter 1: What is Digital Pathology?
Digital Imaging in Pathology
Whole Slide Imaging
A Brief Note on Telepathology

Chapter 2: Current and Emerging Applications
Current Applications
Education
Consultations and Second Opinions
Frozen Section Interpretation
Quality Assurance
Image Analysis
Emerging Applications
Multispectral Imaging
WSI for Primary Diagnosis
Computer Aided Diagnosis

Chapter 3: Market Outlook
What Will Facilitate the Adoption of Digital Pathology?
Barriers
Forecasts

Chapter 4: Regulation and Standards Development
International Color Consortium (ICC)
Digital Imaging and Communications in Medicine (DICOM) Standards Committee
U.S. Food and Drug Administration (FDA)
Clinical Laboratory Improvement Amendments (CLIA)
College of American Pathologists (CAP)
Interview with Craig Revie

Part II: Digital Imaging Technologies: Microscope Imaging Systems

Chapter 5: Applied Spectral Imaging
Company Background
Technologies
Collaboration
Competitive Advantage
Future Endeavors
Digital Pathology Outlook: Standardization and Perspectives
Interview with Limor Shiposh

Chapter 6: Nikon Instruments Inc.
Company Background
Technologies
Collaboration
Competitive Advantage
Future Endeavors
Digital Pathology Outlook: Standardization and Perspectives
Interview with Stanley Schwartz

Part III: Digital Imaging Technologies: Whole Slide Scanners

Chapter 7: 3DHISTECH Ltd.
Company Background
Technologies
P250 FLASH II Scanner
Pannoramic Confocal Scanner
Collaboration
Competitive Advantage
Future Endeavors
Digital Pathology Outlook: Standardization and Perspectives
Interview with Dr. Viktor Varga

Chapter 8: Carl Zeiss Microscopy GmbH
Company Background
Technologies
Collaboration
Competitive Advantage
Future Endeavors
Digital Pathology Outlook: Standardization and Perspectives
Interview with Dr. Thorsten Heupel

Chapter 9: DigiPath Corp.
Company Background
Technologies
Collaboration
Competitive Advantage
Digital Pathology Outlook: Standardization and Perspectives
Interview with Steve Barbee

Chapter 10: FFEI Ltd.
Company Background
Technologies
Collaboration
Competitive Advantage
Future Endeavors
Digital Pathology Outlook: Standardization and Perspectives
Interview with George Hutchinson

Chapter 11: Huron Technologies
Company Background
Technologies
Collaboration
Competitive Advantage
Future Endeavors
Digital Pathology Outlook: Standardization and Perspectives
Interview with Réda Fayek

Chapter 12: Philips Digital Pathology Solutions
Company Background
Technologies
Collaboration
Competitive Advantage
Future Endeavors
Digital Pathology Outlook: Standardization and Perspectives
Interview with Perry van Rijsingen

Chapter 13: Whole Slide Scanners: A Comparison of Specifications

Part IV: Innovation Spotlight

Chapter 14: Innovation Spotlight: PerkinElmer
Company Background
Technologies
Vectra®
Lamina®
Collaboration
Competitive Advantage
Future Endeavors
Digital Pathology Outlook: Standardization and Perspectives
Interview with James Mansfield

Part V: A Case Study - Digital Pathology For Patient Care: The Cleveland Clinic

Chapter 15 An Interview with Thomas W. Bauer MD, PhD The Cleveland Clinic

Part VI: Survey Results: End User And Developer Perspectives

Chapter 16: Survey ResultsTechnological Improvement
Challenges
Benefits
Additional Insights from Technology Developers
Additional Insights from End Users

References

List of Tables:

Table 5.1. Advantages of ASI’s GenASIs Platforms
Table 5.2. ASI GenASIs Imaging Platforms Overview
Table 6.1. DS-Fi2 Camera Overview
Table 6.2. DS-L3 Standalone Control Unit Overview
Table 6.3. Advantages of the Nikon Digital Sight System
Table 7.1. 3DHISTECH Pannoramic 250 FLASH II Benefitsand Limitations
Table7.2. 3DHISTECH Product Overview
Table 8.1. ZEISS Axio Scan.Z1 Benefits and Limitations
Table 8.2: ZEISS Axio Scan.Z1 Overview
Table 9.1. Advantages of the DigiPath PathScope
Table 9.2. DigiPath PathScope Overview
Table 10.1. FFEI Ltd. Dynamo Overview
Table 11.1. Huron Technologies TISSUEscope™ Benefitsand Limitations
Table 11.2. Huron Technologies TISSUEscope™ Scanners Overview
Table 12.1. Philips Ultra Fast Scanner Benefits and Limitations
Table 12.2. Philips Ultra Fast Scanner Product Overview
Table 13.1. Product Comparison: Whole Slide Scanners
Table 14.1. Vectra® Automated Multispectral Imaging System Benefits and Limitations
Table 14.2. Lamina™ Multilabel Slide Scanner Benefitsand Limitations
Table 14.3. Lamina™ Multilabel Slide Scanner Product Overview

List of Figures:

Figure 1.1. Continued Growth of Interest in Digital Pathology
Figure 2.1. Continued Growth of Interest in Multispectral Imaging
Figure 15.1. Survey Respondent Self-Identification
Figure 15.2. Comparison of End User and Developer Affiliations by Organization Type
Figure 15.3. Areas Having the Greatest Room for Improvement According to End Users
Figure 15.4. Aspects of Scanners Having the Greatest Room for Improvement According to End Users
Figure 15.5. Areas of Analysis Having the Greatest Room for Improvement According to End Users
Figure 15.6. Aspects of Scanners Having the Greatest Room for Improvement According to Developers
Figure 15.7. Aspects of Analysis Having the Greatest Room for Improvement According to Developers
Figure 15.8. Challenges Encountered in Technology Development
Figure 15.9. Challenges Facing End Users
Figure 15.10. Perceived Benefits Among End Users
Figure 15.11. End User Perspectives on Where Digital Pathology Will Have the Greatest Impact on Healthcare
Figure 15.12. Developer Perspectives on the Area That Will Benefit Most from Innovations in Digital Pathology Technologies
Figure 15.13. Types of Technologies Being Developed
Figure 15.14. Status of Current Technologies
Figure 15.15. Collaboration Among Technology Developers with Biotechnology and Pharmaceutical Companies
Figure 15.16. According to Developers, “An organization will be successful. .”
Figure 15.17. End User Areas of Research
Figure 15.18. End Users Indicate How Digital Pathology Applies to Their Work