The rapid increase in the usage of digital pathology for clinical applications creates unique challenges for regulatory agencies such as the FDA. The Pathology Visions Conference will tackle the debate about how to regulate the instruments and software that comprise a digital pathology system as medical devices. David Mongillo, M.P.H., M.S., will share his perspective at the 7th annual conference Oct. 30 – Nov. 2 in San Diego, CA.

Mongillo is one of 40 distinguished industry leaders who will present at the international conference. He’ll provide insight into the latest thinking from the FDA and CMS on the regulation of laboratory-developed tests and how new initiatives may impact digital pathology. The Pathology Visions conference will also host a special FDA panel on Nov. 2 that will focus on the digital pathology approval process for primary diagnosis. More details on the FDA panel discussion will be coming soon.

“Current uncertainty surrounding the FDA approval process for primary diagnosis has had a chilling effect on the industry’s ability to promote the patient care benefits of digital pathology,” said Dirk Soenksen, President of the Digital Pathology Association and Chair of the Pathology Visions Program Committee. “Dr. Mongillo’s presentation and the FDA panel are great examples of DPA’s efforts to assemble world experts on this important topic, and to provide a common understanding of uses and potential risks, while sharing perspectives regarding potential regulatory paths for industry and potential guidelines for pathology laboratories.”

Webster will discuss the evaluation and integration of histology pattern recognition software in investigative pathology. The audience will learn how pattern recognition can enhance the quantitative and morphometric ability of pathologists.

Dr. Ochs will share his findings on the evolution of teaching pathology and histology to medical students exclusively on the Web. Students and faculty will be intrigued and inspired by the discoveries from a study conducted at the University of Pennsylvania.

Attending any of the Pathology Visions speakers’ presentations will allow physicians to earn up to 13 CME credits. The three day meeting will include presentations in the clinical, research and education settings. The Pathology Visions Conference has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Indiana State Medical Association and the Digital Pathology Association.Click here for more information about earning CME credits at the conference.

The conference is the perfect learning environment for all types of health care professionals and service providers interested in learning about digital pathology solutions and deployment strategies. Conference attendees will also have access to cutting-edge industry workshops covering innovative topics in digital pathology, DPA white papers and scientific poster sessions, roundtable discussions, the latest product solutions, and networking events.

About the DPA: The mission of the Digital Pathology Association is to facilitate education and awareness of digital pathology applications in health care and life sciences.

The Company’s Digital Pathology Systems to Drive Best Practices in Laboratory Medicine Across Region Skåne, Improving Workflow, Quality Assurance and Enhanced Patient Access to Pathology Services

Vista, CA – August 24, 2011 - Aperio, the global leader in providing digital pathology solutions that improve patient care, today announced that it has contracted with Labmedicin Skåne, of Lund, Sweden, part of Skåne Health Services, to implement 14 digital pathology systems throughout its pathology laboratories located in Helsingborg, Kristianstad, Lund, and Malmö to provide a more robust laboratory service that will expand access to high quality sub-specialized pathology diagnostics to more communities in the Region Skåne. The contract is a collaborative agreement between Aperio, LRI Imaging AB (Aperio’s Swedish distributor), and Software Point, a Finland-based laboratory information systems vendor owned by LabVantage Group. 

Aperio’s digital pathology system will be fully integrated with Software Point’s Sapphire C5 laboratory information system via Aperio’s Spectrum pathology information management software, optimizing workflow and facilitating access to digital slide images and case data between the two systems. Implementation of the integrated solution is anticipated to start in Fall 2011, with plans to be fully operational by Spring 2012. The integrated system will link the four regional hospital pathology labs, estimated to produce 500,000 slides annually, for shared pathology services. 

“We are very excited about the opportunity to access digital slide images and consolidate our pathologists’ workflow into one system,” stated Lena Luts, director of operations for clinical pathology at Labmedicin Skåne. “Digital access to whole-slide image data will completely transform our pathology business, saving our pathologists a vast amount of time. Being able to replace glass slides with digital images will help us significantly improve the diagnostic process and decrease turnaround time for interpretations, resulting in improved quality and patient safety.”

The 14 system installation will include 10 ScanScope® ATs, Aperio’s new addition to its patented line of ScanScope slide scanning instruments. The new ScanScope AT incorporates the very latest technology to deliver the most compact, highest throughput, lowest cost-per-slide, highest-capacity scanner on the market today with superior image quality and highest first scan success rate for high-throughput applications. 

Aperio CEO Dirk G. Soenksen said, “Aperio’s win of this significant contract demonstrates our continued global leadership in providing superior, low cost solutions on the industry’s most robust digital pathology platform. We are honored to provide Labmedicin Skåne with digital pathology solutions that will help define best practices in laboratory medicine and inform better patient care decisions.” 

Scanned images of slides from the four laboratories will be transferred to a central bank. This will improve laboratory workflow and allow pathologists and other employees at the laboratories to follow the specimen from the time the sample arrives at the laboratory until the response is sent to the originator. In addition, pathologists are ensured a permanent and easily accessible digitized slide image for all of their cases, which can be used by surgeons and pathologists from different hospitals to communicate about a case, or for research, audit, or quality assurance purposes. The image bank is expected to be one of the largest in Northern Europe. 

With more system installations than all other digital pathology vendors combined, Aperio is the global leader and reliable choice for world class digital pathology solutions. The company has a global installed base of more than 800 systems in over 30 countries, including more than 500 systems in hospitals and reference laboratories, the 13 largest pharmaceutical companies and a multitude of biotechnology and government organizations. 

Live demonstrations of Aperio’s digital pathology system will be available at Aperio’s exhibit booth (#5a33) at the 23rd European Congress of Pathology, August 27 – September 1, in Helsinki, Finland.  

PathXL (formerly i-Path), a leading provider of Digital Pathology Workflow solutions, and Visiopharm, a technology leader in Whole Slide Image Analysis solutions, today announced the completion of integration between PathXL™ Manager and Visiopharm’s Tissuemorph and Visiomorph toolkits, enabling users across the pathology community to incorporate Image Analysis seamlessly into their collaborative programmes.

The integration provides an open system that streamlines workflows within the lab, as well as between labs with different scanning platforms. It provides a common platform that can be used with all major slide scanner formats, thereby facilitating cross-platform collaboration and leaving users free to choose whichever scanner platform they prefer.

PathXL’s management software and suite of specific applications enable users to upload, archive, search, share, collaborate and report on huge volumes of pathology data without worrying about performance, security or ease of use and without getting locked into expensive proprietary standards and systems .  PathXL can either be provided fully deployed on the customer’s site or as a hosted service over the web. This hosted option allows users to realise the full benefits of digital pathology, without major capital investment and without the need to support the solution in-house.

Visiopharm’s software provides efficient tools for extracting morphometric data from Whole Slide Images.  It is designed specifically for Pathologists, providing simple controls for identification, classification, and quantification of nuclei, membrane, cytoplasm and other structures of relevance.   It allows pathologists to work in true stain space (through colour de-convolution).  The technology is based on some of the most recent breakthrough research in image analysis and pattern recognition; and the software has been designed to reduce both the cost of learning and the cost of computing.  

The combination of these two solutions announced today, will allow users of Digital Pathology to benefit from a complete Digital Pathology solution. 

Des Speed, CEO of PathXL said ‘It is clear that Research customers are increasingly turning to Image Analysis tools, and naturally expect to be able to use these tools like any other - managing, sharing and collaborating with Image Analysis results in the same way as they do for standard digital pathology images and metadata.   From the outset, we’ve built our PathXL web platform to meet the highest architectural and usability standards - intuitive, robust, fast and secure, and also flexible and open to ensure future-proofing, whatever new applications and processes emerge.  We see Visiopharm as sharing the same philosophy and setting the same high standards in their specialist market, so we believe this collaboration enables customers to get the best of both worlds – great Image Analysis on a great Platform!’ 

Michael Grunkin, CEO of Visiopharm said ‘The ability to support complete workflows is becoming increasingly important, as pathologists seek to extract significant return on the investment from Digital Pathology. The open platform philosophy underpinning the solutions provided by both of our companies, will make it a lot easier for pathologists to choose best-of-breed solutions for analysis and data management and integrate them into one coherent workflow.  We believe that this will become increasingly important, not just internally in a research lab, but also in cross-platform collaborative efforts between different research groups.’

An example of the PathXL Visiopharm integrated image analysis system.

About PathXL

PathXL specialises in web-based software and workflows for Digital Pathology.  Its PathXL™ Manager product provides a robust, secure and open web-based platform to enable digital pathology users across all fields to manage, view and collaborate around virtual slides easily and efficiently.  In addition, PathXL provides a range of applications and workflows on top of PathXL™ Manager to deliver specific solutions to pathologists, scientists and students in Education, Research, Clinical and Biobanking settings.  PathXL also provides a full range of supporting services, including scanning, hosting, image analysis and consultancy.  PathXL operates in the UK, Europe and North America.

i-Path Diagnostics will complete its global corporate rebrand to PathXL on 27th August 2011 following the PathXL launch in the USA earlier this summer.

PathXL is a global pioneer in the use of web-based solutions for digital pathology and provides innovative software for use in education, research and clinical sectors worldwide.

The rebrand reflects the company’s expansion on two fronts. Geographically PathXL has announced a number of strategic partnerships in recent months which strengthen its position to achieve rapid growth outside the UK and Europe - more announcements to follow.  PathXL has also broadened the development and promotion of its workflow capabilities to create a comprehensive digital pathology platform that is web-based, open, and affordable.  PathXL is committed to delivering digital workflow excellence.

The company will rebrand to PathXL at the European Congress of Pathologists in Helsinki on 27th August. If you are visiting the conference, please join us at our new PathXL stand 5C46.

Des Speed, CEO of PathXL commented:

    “Our company is already recognised as being the leader in digital pathology education software, with an estimated 60% of UK trainee pathologists using PathXL’s innovative web-based platform each year.   We recognise that digital pathology is moving from an era of point solutions to much greater maturity - transforming entire workflows in education, research and ultimately clinical use.    We intend to become recognised as the visionaries and leaders in digital workflow excellence.”

http://www.pathxl.com

A group of us recently summarized our thoughts from respective talks presented at the College of American Pathologists Companion Society meeting at this years' United States and Canadian Academy of Pathology.

I previously summarized who spoke at the actual meeting (see: Thoughts on CAP Companion Society Meeting at USCAP 2011).  

The publication is avaialble free of charge from the Journal of Pathology Informatics (see links) or you can download the PDF here.

Review of the current state of whole slide imaging in pathology Liron Pantanowitz1, Paul N Valenstein2, Andrew J Evans3, Keith J Kaplan4, John D Pfeifer5, David C Wilbur6, Laura C Collins7, Terence J Colgan8 1 Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA 2 Department of Pathology, St. Joseph Mercy Hospital, Ann Arbor, MI, USA 3 Department of Pathology, (UHN) Toronto General Hospital, Toronto, ON, Canada 4 Carolinas Pathology Group, Charlotte, NC, USA 5 Department of Pathology, Washington University School of Medicine, Saint Louis, MO, USA 6 Department of Pathology, Massachusetts General Hospital, Boston, MA, USA 7 Department of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA 8 Department of Laboratory Medicine and Pathology, Mt. Sinai Hospital, Toronto, ON, Canada   Correspondence Address: Liron Pantanowitz Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA  USA © 2011 Pantanowitz et al; This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. DOI: 10.4103/2153-3539.83746    Abstract     Whole slide imaging (WSI), or "virtual" microscopy, involves the scanning (digitization) of glass slides to produce "digital slides". WSI has been advocated for diagnostic, educational and research purposes. When used for remote frozen section diagnosis, WSI requires a thorough implementation period coupled with trained support personnel. Adoption of WSI for rendering pathologic diagnoses on a routine basis has been shown to be successful in only a few "niche" applications. Wider adoption will most likely require full integration with the laboratory information system, continuous automated scanning, high-bandwidth connectivity, massive storage capacity, and more intuitive user interfaces. Nevertheless, WSI has been reported to enhance specific pathology practices, such as scanning slides received in consultation or of legal cases, of slides to be used for patient care conferences, for quality assurance purposes, to retain records of slides to be sent out or destroyed by ancillary testing, and for performing digital image analysis. In addition to technical issues, regulatory and validation requirements related to WSI have yet to be adequately addressed. Although limited validation studies have been published using WSI there are currently no standard guidelines for validating WSI for diagnostic use in the clinical laboratory. This review addresses the current status of WSI in pathology related to regulation and validation, the provision of remote and routine pathologic diagnoses, educational uses, implementation issues, and the cost-benefit analysis of adopting WSI in routine clinical practice. Keywords: Consultation, diagnosis, digital, education, frozen section, imaging, informatics, telepathology, validation, virtual microscopy, whole slide imaging How to cite this article: Pantanowitz L, Valenstein PN, Evans AJ, Kaplan KJ, Pfeifer JD, Wilbur DC, Collins LC, Colgan TJ. Review of the current state of whole slide imaging in pathology. J Pathol Inform 2011;2:36 How to cite this URL: Pantanowitz L, Valenstein PN, Evans AJ, Kaplan KJ, Pfeifer JD, Wilbur DC, Collins LC, Colgan TJ. Review of the current state of whole slide imaging in pathology. J Pathol Inform [serial online] 2011 [cited 2011 Aug 23];2:36. Available from: http://www.jpathinformatics.org/text.asp?2011/2/1/36/83746

Courtesy of the Digital Pathology Association.

I think this years' program will be among the best line up of speakers, topics (including update from the FDA on their thoughts), exhibitors, posters and networking opportunities this meeting has had.  The talks and meeting come at an important time for digital pathology including new vendors in the space, regulatory issues and new business models, all of which will be discussed. 

2011 PATHOLOGY VISIONS CONFERENCE

"Access to sub-specialist pathologists using telepathology and image analysis of biomarkers are two of the strongest value propositions for why institutions adopt digital pathology," said Dirk Soenksen, President of the Digital Pathology Association and Chair of the Pathology Visions Program Committee. "Attendees at this year's conference will learn best practices for these and other applications of digital pathology, as well as how digital pathology can improve patient care and enable personalized medicine."

Click Here to Register

Conference attendees will also have the opportunity to earn up to 13 CME credits, take part in an FDA panel discussion, and participate in cutting-edge industry workshops. DPA white paper and scientific poster sessions, roundtable discussions, networking events, and dozens of exhibitor displays will round out the three day conference.

By Matt Pross, TEQ Staff Writer

Nice piece on Omnyx and their approach.  Digital pathology is often cited as a $2 billion market as is mentioned a couple times in this story.  

"Leave it to the big boys to go and carve out a $2 billion global market with the goal to redefine pathology worldwide. That’s exactly what GE Healthcare and the University of Pittsburgh Medical Center (UPMC) set out to do when they partnered to form Omnyx™. Focused on developing an entirely digital, integrated pathology solution, the joint venture has made significant progress toward this formidable goal since its founding in March 2008.

“The technology that was in use before OMNYX had a very niche focus and was used mainly in low volume/niche applications,” Tony Melanson, Vice President, Strategy & Marketing for OMNYX, said. “We saw the shortcomings of this technology and asked ourselves ‘what would it take to create a solution that would enable the high quality and high throughput necessary for pathology to evolve from an analog workflow into a digital practice?’ With its foundation in information technology systems for radiology, GE saw digitizing pathology as a natural progression and a great fit into the company’s existing portfolio. 

We also knew pathology was uncharted territory and decided to solicit the help of Carnegie Mellon University and their leading Human Computer Interaction teams to help us design an efficient workflow and appealing user interface with the help of UPMC pathologists.""

Read full story.

—

Among other topics, this FREE White Paper specifically addresses:

1. Unique lab work flow needs
2. Some common interface challenges
3. Off the shelf LIS vs custom LIS solutions
4. Implementing LIS into your lab, a sample case study

For more about LIS and NeTLIMS, please CLICK HERE

Table of Contents

Executive Summary & Objectives — Page 3

Chapter 1. What is a Laboratory Information System? — Page 7

Chapter 2. Standards and the Interface Challenge — Page 12

Chapter 3. The Multiple Component Challenge — Page 18

Chapter 4. Off-The-Shelf Versus Customizable LIS’s — Page 22

Chapter 5. The Implementation Challenge — Page 24

Chapter 6. Case Studies: Implementing a Laboratory Information System — Page 27

Chapter 7. Conclusion — Page 32

Appendices

A-1 About Gerald Choder — Page 36
A-2 About NeTLIMS — Page 37
A-3 About DARK DAILY— Page 38
A-4 About The Dark Intelligence Group, Inc., and The Dark Report — Page 39
A-5 About Executive War College on Laboratory and Pathology Management— Page 40
A-6 About Mark Terry — Page 42

Terms of Use — Page 44

Leica Microsystems, world-leading providers of Total Digital Pathology solutions, and Visiopharm the leading provider of Histoinformatics Solutions for Life-Sciences, today announce the completed integration of Leica’s SlidePath Digital Image Hub with Visiopharm’s Whole-Slide Informatics™ solutions for Digital Pathology.
Users can now take advantage of superior image capture and management from Leica Microsystems and excellent Whole Slide image analysis and Whole Slide Stereology from Visiopharm in a single system.

A distinguished field of 41 speakers will highlight the hot topics in the world of digital pathology at the 2011 Pathology Visions Conference. Telemedicine, neuropathology, and the image analysis of biomarkers are just some of the subjects experts will discuss at the 7th annual Digital Pathology Association Conference Oct. 30 – Nov. 2 in San Diego, CA.

DigiPath follows course of several whole slide imaging device manufacturers and licenses Olympus patents.

HENDERSON, Nev. and CENTER VALLEY, Pa., USA, August 17, 2011 -- DigiPath, Inc^®, a provider of affordable, innovative and reliable digital pathology solutions, and Olympus America Inc., a precision technology leader designing and delivering innovative solutions in life science imaging and other product areas, have entered into a nonexclusive worldwide agreement allowing DigiPath and its OEM partners to access an extensive portfolio of Olympus patents in the field of virtual microscopy and digital pathology. The patents involved in the licensing agreement cover methods, software and technology for creating, storing and delivering virtual microscopy images.

Virtual microscope slides enable professionals to review biopsies and other pathology images without handling traditional glass slides, and allow doctors to share high-resolution digital microscope images over telecommunication networks for second opinion consultation, tumor board review, and image archiving functions.

"Licensing these patented technologies and approaches to innovative new companies like DigiPath is very important to us," said Mr. Hidenao Tsuchiya, Vice President and General Manager of Olympus America Inc., Scientific Equipment Group. "Agreements like this help foster widespread digital imaging adoption where affordability and improving advanced patient care are vital."

"DigiPath is delighted to work with Olympus," said Eric Stoppenhagen, Chief Executive Officer for DigiPath.  "Our clients and OEM partners can be assured their investments in digital pathology are stable and secure."