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Too Early = Too Late = Too Stupid: The Right Time To Use Image Analysis In Regulated Pathology
Aug 26th, 2010 by alowe

Register for an exciting new webinar on September 23rd at 12 PM EST/ 9 AM PST.  The webinar titledToo Early = Too Late = Too Stupid: The right time to use image analysis in regulated pathology” is hosted by Steve Potts PhD, CEO of Flagship Biosciences, a digital pathology services firm working in preclinical toxicology and companion diagnostics.

Topic:

The computer  is a valuable pathologist tool, but not a patho-droid. In this hopefully humorous hour, you will hear why image analysis will enhance the professions of both veterinary and medical anatomic pathology and how to  use this tool effectively.

  • Clinical and preclinical regulations you need to be aware of, as demystified as possible.
  • How the computer thinks about image analysis, and how the most common biomarker  algorithms work.
  • Is the computer lying? Practical ways to evaluate algorithm performance.
  • Putting pathologists back in charge – taming the patho-droid paranoia

About Steve Potts, PhD

Dr. Potts joined Flagship from Aperio, where he was Vice President of Life Sciences. He managed worldwide sales and marketing in the biopharma segment, where his team achieved global adoption by nearly all of the largest pharmaceutical companies. He defined and led the GLP product development and validation services for the use of whole slide images in regulated preclinical and clinical trials studies, as well as the development of image analysis techniques for angiogenesis. Prior to Aperio, he was Head of Bioinformatics and Biostatistics at Quest Diagnostics Nichols Institute, where his team supported the development of In Vitro Diagnostics Multianalyte Assays (IVDMIA) in oncology and other therapeutic areas. He was a product manager at Accelrys, where he created a protein-ligand data management system for medicinal and computational chemists, crystallographers, and biologists to provide structural bioinformatics data across multiple pharmaceutical departments. He earned a Ph.D. and M.S. in Biological Engineering, and an MBA from the University of California at Davis, and a B.S. in Physics from Wheaton College, Illinois. He has over 20 peer-reviewed publications and patents.

REGISTER TODAY!

DICOM: A New Language in Digital Pathology
Aug 25th, 2010 by alowe

For over 10 years, the digital pathology industry has been riddled with vendors speaking their own language or languages (aka file format). Today a major milestone in interoperability was achieved with the final approval of Supplement 145; a DICOM universal format for whole slide images.  Although vendors will never give up their native tongue, this new supplement creates a universal language everyone can understand in digital pathology, even those outside of our industry.

WG-26, lead by Bruce Beckwith, MD, has worked hard for several years to create supplement 145.  Harry Solomon of GE Healthcare contributed a lot of help over the past year to move this to ballot and beyond.  Harry put forward the following comments in an email to WG-26 today:

I’d like to add my thanks to the members of DICOM WG-26 for the significant body of pathology domain knowledge that has been added to the DICOM Standard, both in this new Supplement 145, and in Supplement 122 in 2008.  That knowledge is now available to further improve interoperability in a field that was early to health informatics standards with the Systematized Nomenclature of Pathology, now known as the Systematized Nomenclature of Medicine (SNOMED), and is now poised for a significant leap with digital pathology.

Here are some statistics on that domain knowledge base:

  • One major new DICOM Information Object Definition (Whole Slide Imaging) with new concepts to manage the huge WSI data set
  • A major revision of a DICOM Information Entity (Specimen) with a rigorous information model
  • 56 new data elements added to the DICOM Standard in 14 new or revised modules
  • 7 new or revised DICOM structured data templates and 18 new defined value sets
  • 80 new coded terminology concepts added to SNOMED, and 36 added to DICOM
  • 40 pages of explanatory information about pathology workflow and imaging

Overall, this is another major step forward in the clinical use of digital pathology.  Thank you to everyone who worked hard to make this a reality!  The final document will be available within the next week.

ADVANCE Article: Putting the Digital Pieces Together
Aug 13th, 2010 by alowe

Below is an article I wrote for ADVANCE for Laboratory Professionals, Perspectives In Pathology.

Putting the Digital Pieces Together

By Amanda Lowe

Digital pathology is often described as the scanning of a glass slide into a whole slide image; yet, it is much more. It is so much more, in fact, that pathologists and laboratory professionals find themselves puzzled with how it will affect their future. As technology progresses, we must start to understand how to put the pieces of it together—from acquisition to integration to data management and interpretation.

Acquisition

Acquisition of a whole slide image from a glass slide is done on a slide scanner, which creates the image necessary for interpretation. Important elements of slide preparation and patient information can make the acquisition process simple or complex.

Slide preparation is a crucial and often overlooked element of digital pathology. Pathologists can handle slide artifacts such as folds and air bubbles under a microscope; slide scanners are not always as forgiving. Also, staining has to be perfected, not only for scanning but for accurate interpretation and use with image analysis software. Poor staining can result in tissue not being scanned, inaccurate image analysis data—and in the worst case—a wrong diagnosis.

Traditionally, when glass slides are prepared, they are manually matched with the patient paperwork (including patient history, requisition and gross review), then delivered to the pathologist. With digital pathology, the process looks different. You now have whole slide images that need to be reconciled to the digital patient paperwork, then delivered to the pathologist. The only way to do this is with a laboratory information system (LIS), electronic medical record (EMR) integration, and bar codes. Bar codes will reduce human error, save time on the constant need for verification and re-checks, and improve quality assurance by tracking all specimens throughout the histology process.

Integration

The LIS and often the EMR need to share information with the digital pathology software to create a pathology picture archiving and communication system (PACS) that consolidates all patient paperwork, gross images and whole slide images for interpretation. This is the most important but also the most difficult piece for labs to handle. The process can be costly and require collaboration of two or more vendors, which can be a frustrating and hard process to manage. However, it can be accomplished with a plan, a budget and someone to manage the project.

Data Management

Many hospitals do not have adequate IT resources or the expertise to handle their already stressed storage demands. Yet these whole slide images have to be stored somewhere. Unfortunately, most IT departments do not understand the fundamentals of digital pathology. Pathology leaders and their lab personnel must improve communication with their IT departments and take an active role in educating IT on the realistic needs of the department now and over the next five years. Hospitals have to prepare for the increase in lab data and pathology images that will soon be their future.

To estimate your whole slide image storage needs, divide the number of surgical slides your lab generates per year by 3,500 to get an estimate of terabytes needed annually; 3,500 is the average number of whole slide images per one terabyte.

Healthcare providers are required to save medical records for a specified time; for most, this is a minimum of seven years. Security is not optional, and HIPAA mandates backup and disaster recovery plans for patient records, including all medical images. The specialty of pathology will not be an exception to the rule.

Interpretation

One goal of digital pathology is to enhance the sign-out process for pathologists. Pathologists should be able to sit down at a computer monitor to sign out digital cases retrieved from a pathology PACS system. Easy access to archived cases for disease progression or comparison, rapid case sharing and consultations, data mining for decision support and image analysis will all help improve the diagnostic process.

Powered by the rapid and endless growing portfolio of image analysis algorithms, pathology will transition from a qualitative to a quantitative discipline. Digital pathology partnered with image analysis will create the infrastructure necessary so pathologists can confidently determine the severity of a disease and predict responses to a target therapy.

Digital pathology streamlines laboratory workflow, enhances the sign-out process, and can improve diagnostic outcomes and treatment responses for patients while at the same time forge a new foundation for the use of pathology data to drive translational research and higher standards of care.

Pathology 2.0 Webinar
Aug 10th, 2010 by alowe

In the true spirit of 2.0,  I felt it was important to blog about the wonderful webinar presented today by Dr. Keith Kaplan, titled Pathology 2.0.  Pathology 2.0 is a phrase created by Dr. Kaplan to illustrate the convergence of social media and Web 2.0 into Pathology, and his webinar discusses the impact and/or disruption Pathology 2.0 can have on surgical pathology.

Pathology 2.0

  • Biomarkers, targeted therapies, dedicated chemotherapy
  • Allows for the sharing of images, collaborative diagnoses, educational forums, tumor boards, etc
  • The “tissue is the issue”- remains at the center
  • Convergence of improved pathology and advanced communication

On a personal note, thank you Keith for your contribution to this webinar series and for your support of my efforts to leverage Web 2.0 and social media to grow my company, especially through this blog. Your continued contributions to the pathology and digital pathology community make a difference; a difference that is appreciated and valued.

If you missed the webinar and would like to learn more, download the recorded presentation and make sure to read Dr. Kaplan’s blog at www.tissuepathology.com.  The presentation will require windows media player to view.  Thank you again to everyone who attended and please remember to register for our next webinar, Image Analysis In a Regulated Environment presented by Steve Potts, PhD, on September 23rd, 2010 at 9 AM PST/12 PM EST.

Pathology 2.0
Aug 3rd, 2010 by alowe

One week from today on August 10th at 12 PM EST / 9 AM PST, the second webinar in a new series titled “Pathology 2.0″ will be presented by Keith Kaplan, MD.

Topic Overview

This webinar is designed to enhance your knowledge of Pathology 2.0.  Dr. Kaplan  will Increase your knowledge of 2.0 tools and technologies, teach you how 2.0 will apply to the daily practice of surgical pathology, and give you an understanding of the long-term implications of 2.0 for our practices.  In addition, you’ll learn how to improve your services and showcase your specialty while providing information to patients that was once locked away.  To learn more about Pathology 2.0 read an article from CAP Today “Manifest destiny—Pathology 2.0 is here,and it’s clear. Time to climb aboard.”

About Keith J Kaplan, MD

Dr. Kaplan is a surgical pathologist and chief information officer for Carolinas Pathology Group and Celligent Diagnostics.  He was formerly associate professor of pathology at Mayo Clinic College of Medicine where he served as Biospecimens Director for the North Central Cancer Treatment Group (NCCTG).  He received his MD degree from Northwestern University Feinberg School of Medicine followed by residency training in anatomic and clinical pathology at Walter Reed Army Medical Center.  While at Walter Reed, in conjunction with the Armed Forces Institute of Pathology he founded and directed the Army Telepathology Program connecting 25 hospitals worldwide for consultation via telepathology.  He has authored over 60 peer-reviewed scientific articles book chapters, editorials and scientific abstracts.  His subspecialty interests include gastrointestinal and hepatic pathology, cytopathology and pathology informatics and has presented at national and international meetings on those topics. Dr. Kaplan’s research interests involve gastrointestinal and hepatobiliary pathology, hyperspectral imaging, image analysis and the use of Web 2.0 tools in pathology.  He is active in many medical societies including the College of American Pathologists where he has chaired or served on several committees, serves as a reviewer for many scientific journals, serves on the editorial board for Human Pathology and blogs daily at www.tissuepathology.com.

REGISTER TODAY

This webinar is provided by www.thedigitalpathologywiki.com and it’s sponsors.

Digital Pathology: How To Put The Pieces Together
Jul 21st, 2010 by alowe

Thank you to everyone who attended my webinar yesterday on “Digital Pathology: How To Put The Pieces Together.”  The webinar was designed to be a simple, yet informative presentation about the essential pieces of any digital pathology program.  These pieces include:

  • Acquisition: Acquire great images easily
  • Integration: Enable software to communicate
  • Data management: Your options and how to get IT support
  • Interpretation: Image Analysis, Decision Support, Consultations

If you missed the webinar and would like to learn more, download the recorded presentation.  The presentation will require windows media player to view.  Thank you again to everyone who attended and please remember to register for our next webinar, Pathology 2.0 presented by Dr. Keith Kaplan, on August 10th, 2010 at 9 AM PST/12 PM EST.

Flagship Biosciences Partners with PrognosDx for Oncology Clinical Trial Services
Jul 20th, 2010 by SPotts

Flagstaff, AZ (PRWEB) July 19, 2010  Flagship Biosciences LLC, a provider of digital pathology services, announced today an exclusive partnership with PrognosDx Health to provide pharmaceutical companies and cancer centers with access to tissue-based, global patterns of histone modification patient profiling for use in early stage drug discovery and various phases of clinical trials. PrognosDx Health is an early-stage epigenetics company with unique global patterns of histone modification patient profiling technology.

“Epigenetic changes in gene regulation that are not specifically due to direct alterations in DNA have been demonstrated to drive tumor progression and response to therapy,” commented Amato Giaccia, Ph.D., Professor of Radiation Oncology and Associate Director for Education at the Comprehensive Cancer Center at Stanford University. Dr. Giaccia added: “The ability to detect changes in histone methylation and use them to assess tumor progression or predict response to therapy is a powerful new approach that has significant clinical implications, which was recently demonstrated in a study published in the Journal of Clinical Oncology that showed high levels of H3K4me2 and/or H3K18ac were predictive for increased survival. These exciting studies represent the future of molecular pathology.”

“Pharmaceutical oncology clinical programs and cancer centers are both struggling with the ability to effectively profile their patient populations during clinical trials,” said John Bloom, a well-known leader in companion diagnostics development and a board member of Flagship Biosciences. Dr. Bloom added: “Epigenetics is an emerging valuable addition of information that may help to drive better prognostic decisions from study enrollment through late-stage trials. We are excited to see PrognosDx’s technology platform be made readily available to these pharmaceutical and cancer center groups through the services and partnership with Flagship Biosciences.”

Flagship and PrognosDx have agreed to a profit sharing business arrangement, which primarily is based on providing laboratory testing services to companies with early stage drug discovery programs as well as those companies needing to test their preclinical or clinical phase tissue samples. These services will be launched in Q3, 2010 and will initially focus on testing of specimens related to therapeutic oncology programs within pharma where global patterns of histone modifications patient profiling may identify sub-population of the patients who will be the likely responders to the drugs in development. These testing services will also apply to animal studies, target identification, target validation, and efficacy studies especially for HDACi class of compounds, various pro-drugs, certain chemotherapeutics, compounds inhibiting the nucleotide synthesis process as well as those compounds impacting certain proprietary metabolic pathways.

Kamran Tahamtanzadeh, Founder and CEO of PrognosDx, stated, “Flagship Biosciences brings a unique combination of pathology expertise and image analysis talent, and the ability to run preclinical and clinical trial studies in a regulated environment. This partnership will meet the demand from our pharmaceutical clients for easily-available, high-quality clinical trials patient profiling services. We see great benefit in partnering with Flagship’s leaders, who are well-known experts in digital pathology services wherein a foundation of test accuracy and reproducibility is required. Furthermore, we believe that the highest-quality IHC and digital analysis is critical to quantitative histopathologic evaluation and we are confident that Flagship has the expertise to deliver this important test in support of cancer patients.”

About Epigenetics

Epigenetics refers to the regulation of genes with mechanisms other than changes to the underlying DNA sequence and such processes are widely believed to play a central role in the development and progression of almost all cancers. Such epigenetic processes are controlled by DNA methylation and histone modifications.

About Flagship Biosciences

Flagship Biosciences is a pathologist-owned company whose mission is to improve tissue assessment in pharmaceutical and medical device development. Flagship’s services include quantitative pathology assessment on-demand, low-cost digital pathology slide scanning, secure hosting, pathologist-supervised IHC and histology placement, and custom image analysis and companion diagnostics development. All of their services are reviewed and supervised by board-certified pathologists. For more information, please visit the website www.flagshipbio.com

About PrognosDx Health

PrognosDx Health, Inc. is an early-stage life science company formed to significantly improve the treatment of cancer and other complex diseases by developing novel, semi-quantitative and quantitative laboratory products based on global patterns of histone modification through technology it has exclusively licensed from the University of California, Los Angeles (UCLA). This platform technology has broad potential uses in the development of cancer prognostic assays, therapeutic response prediction assays, as well as research tools and reagents. A network of renowned academic researchers and clinicians supports PrognosDx Health, with expertise in the fields of cancer and epigenetics. The company has its headquarters in Palo Alto, California. PrognosDx is currently in the process of selecting strategic diagnostic partners for development of advanced IVD products for variety of cancer indications. The company also has plans to form strategic partnerships and license out its high value, histone-based biomarker tests to select and highly specialized CLIA laboratories in the US and abroad. For further information, please visit the website www.prognosdx.com.

Read the Press Release through PRWeb

Learn more about Epigenetics in the TIME article “Why DNA Isn’t Your Destiny”

And The Gold Medal Goes to…
Jul 19th, 2010 by alowe

Just like the Olympics, multiple gold medals were given out at the first annual European Scanner Contest.  The gold medals went to Leica, Olympus, & 3DHistech!

In a previous post, “Going For The Gold! A Digital Pathology Olympics” I discussed how on May 25th-26th the first contest was held with six companies choosing to participate.  The participants had the option of competing in up to three disciplines with a maximum of two scanners.

The disciplines were:

  1. Quality: 10 slides scanned at 20x and 40x then reviewed by a panel of pathologists
  2. Mass: 35 slides scanned at 20x and 40x then assessed by speed, focus, particles, and stitching
  3. Cytology: 12 Pap slides scanned a 20x and 40x then assessed by speed, focus, and stitching
  4. IHC: HER2, CerbB2 at 40x and then assessed for speed and focus
  5. Cytology: Pap +MKI67 and then assessed for speed and focus

The following awards were presented at the 10th Annual European Congress on Virtual Microscopy in Vilnius, Lithuania July 1-3, 2010, based on specific requirements and evaluation rules.

  • Olympus received two awards for their VS-110 scanner in the Quality category for mixed scan at 20x and for 40x .16 µm/pixel
  • 3DHistech received one award for their Pannoramic Scan 150 for Quality category for mixed scan at 40x 0,23-0,25 µm/pixel
  • Leica received two awards for the SCN400 scanner for the Mass category in both 20x and 40x

Congratulations to the winning companies and their instruments, and I look forward to future contests and encourage more companies in our industry to participate.   For additional information, download the following powerpoint presentation about the contest and an overall summary of results.


Digital Pathology Consultants Launches a Digital Pathology Webinar Series
Jul 12th, 2010 by alowe

Broomfield, CO (PRWEB) July 12, 2010 Digital Pathology Consultants, a leader in digital pathology consulting services announced today the start of a free webinar series provided by www.thedigitalpathologywiki.com and its sponsors; established to arm adopters and users with the information necessary to be successful with digital pathology.

The series will kick off with “Digital Pathology: How to Put The Pieces Together” presented by Amanda Lowe, President of Digital Pathology Consultants on July 20, 2010 at 12 PM EST. Amanda will provide an overview of the key pieces of digital pathology including acquisition, integration, data management, and interpretation and how to efficiently put the pieces together. This is an excellent webinar for individuals who are planning to adopt a digital pathology solution, or who have a solution and want to know how to maximize the investment and use the technology to its full potential.

The series will continue with a monthly one-hour webinar presented by industry leaders to educate the community, share best practices, keep current on industry advancements, and to cultivate healthy discussions about digital pathology.

Future webinars include “Pathology 2.0″ presented by Keith Kaplan MD a Surgical Pathologist and CIO at Carolinas Pathology Group, on August 10, 2010 at 12 PM EST and “Image Analysis In A Regulated Environment” by Steve Potts PhD, CEO of Flagship Biosciences on September 23, 2010 at 12 PM EST.

The webinar series is free to all registered attendees, however space is limited. Register today for this unique opportunity where the information you learn can be applied immediately.

About Digital Pathology Consultants, LLC

Digital Pathology Consultants, founded by Amanda Lowe, is the leading provider of digital pathology consulting services for the biopharma and healthcare industries. Our services help clients research, plan, select, implement, and validate digital pathology solutions. Knowledge, trust, and an open exchange forum shape the foundation of Digital Pathology Consultants. Delivering results is our promise, exceeding your expectations is our guarantee.

Read the Press Release here

Contact:

Amanda Lowe

Digital Pathology Consultants, LLC

PO Box 486

Broomfield, CO 80038

phone: 877-843-5268

email: info@digpathconsultants.com

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Digital Pathology In Education
Jul 9th, 2010 by alowe

My first position in digital pathology sales, was to sell virtual microscopy server software to medical, dental, and veterinary schools as an adjunct to microscopy or for the replacement of microscopes.  I loved selling this product and I loved the people I sold it to; this position truly sparked my passion for digital pathology.

With one of my favorite annual educational meetings the International Association of Medical Science Educators (IAMSE) starting this weekend in New Orleans, I thought it was the perfect time to talk about the current state of digital pathology in education and provide some helpful advice to those who use virtual slides or are considering adding virtual slides to their curriculum.

Want to add virtual slides to your curriculum?

  1. You can start out slow and gradually convert to a virtual slide based curriculum.
  2. Do not under estimate the importance of your servers and network infrastructure.  Without a solid infrastructure, no program will be successful.
  3. Have more than one champion! You cannot do this alone, nor do you want to.  The #1 reason a program fails, or does not last is because the faculty do not want to accept the technology or the champion leaves the program.
  4. Talk with your colleagues.  With approximately 50% of programs using virtual slides you will know someone who can share their experiences, best practices, or that you could collaborate with.
  5. There is lots of published data.  Visit www.thedigitalpathologywiki.com and visit the education section for a list.

A few years ago education was a big area of focus for several manufacturers, but now the focus has shifted to the clinical use of digital pathology for primary diagnosis.  Although this shift is not a surprise, we must not forget that without the acceptance of digital pathology in education we would not be where we are today.   The foundation that digital pathology in education creates is essential to the growth and acceptance of this technology worldwide, and to the interest of histology and pathology as medical professions.

Need to change or update your virtual slide based curriculum?

  1. You have options! Most manufacturers now support multiple virtual slide formats so that you do not lose all the virtual slides and content you have created over the years.
  2. You must budget for and plan to update your servers and evaluate your network infrastructure.
  3. Worried about support and upgrades from your current provider? No one will pull the plug, but software upgrades may stop.  Therefore, you may want to create a migration strategy.

The kindness, generosity, and patience of educators is remarkable.  One of my favorite moments was when Dr. Mark Braun of Indiana University in Bloomington gave thanks to me on his poster at an IAMSE meeting, but really it is me who should be giving thanks. Thank you to all the educators who I have worked with over the years- you all contributed to my professional growth and understanding of histology and pathology.

If you are a member of CAP, take the FREE Digital Pathology Interactive Presentation: The Exciting and Expanding Role of Digital Pathology in Pathology Education

Current providers of digital pathology solutions for education:

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