Steve Potts, PhD CEO of Flagship Biosciences gave a great webinar last week on the right time to use image analysis in regulated pathology.   Steve was faced with the challenge of trying to convey a meaningful message to a diverse audience from both the biopharma and clinical markets.   He kept everyone engaged on this detailed, ever evolving topic which provided information on FDA, CLIA, CAP/ASCO, and GLP regulatory guidelines.  Steve did this well, and kept us laughing throughout the presentation.

Navigating regulatory guidelines for image analysis and digital pathology will never be easy, however there are several ways you can effectively use these technologies today while safe guarding yourself.  Steve provides a lot of information and resources in his powerpoint that can help organizations work through and understand just how to do this.

As for when is the “right time”?  Well, you’ll have to download the recorded webinar and Steve’s powerpoint slides to find out!  Thank you Steve for your time and for presenting on this important topic!

Download the Video

Download the presentation

Stay tuned to this blog and/or register for my newsletter to find out about our future webinars.

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”

By Steve Potts, PhD

The formal training of pathologists has an impressive history, and pathology boards for both medical and veterinary pathologists are very difficult professional exams. As digital pathology slowly makes it way from a early adopter technology to mainstream, there will be an increased need for training of the “digital” pathologists, both in working remotely with digital slides (which is fairly quick to pick up) to image analysis (which takes more time and specialization). The vendors of digital pathology scanners generally offer basic and generic software training, and have done a good job of educating the pathologists in how to use the tools. However, much more work needs to be done across the industry in improving training opportunities for pathologists using quantitative analysis, both in the research and clinical markets.

The challenge of image analysis training in the clinical environment is illustrated by a question I had from the audience at a talk I gave recently on Validation of Image Analysis in GLP and CLIA environments. Someone asked,

We use the ER/PR algorithms from the manufacturer on Ki67 out of the box, and we want to know how to validate them?

The problem with this simplistic approach is that Ki-67 has a binary thresholding criteria rather than multilevel in ER/PR, and the Ki-67 staining patterns are generally much different in the nuclei than ER/PR and usually require tuning changes in how the software scores. And Ki-67 is a very simple marker! The best validation process is useless unless the pathologist knows how the algorithms work, and has a generally good understanding of image analysis concepts. While we are working actively on better validation approaches for image analysis for both clinical and GLP preclinical environments, real world training in image analysis must come first.

So prior to our plans for image analysis validation services, we first need to make training of image analysis more accessible to pathologists as well as imaging scientists and support personnel at pathology centers. This is a difficult activity for vendors to do, as it really should be taught by a combination of pathologists and image analysis experts. So many image analysis results heavily depend on the condition of the tissue in staining, fixation, or other histology steps, the pathologist needs to be involved in training to be able to point out some of these things. IHC overstaining is the precise reason that pathologists need to work closely with histotechnologists in determining the exact antibody dilution to use with each stain.  Close communication avoids other artifact pitfalls that affect pathology endpoints and analytical consistencies. Some antibody vendors actually customize their IHC processes to make the antibody stains much darker, which might(?) be helpful to the human eye, but is poor for image analysis, where lighter staining is usually much better. If I had a dollar for every time someone has asked for an algorithm that will work on overstained IHC slides, well, I could buy a couple more slide scanners.

The other reason it is difficult for vendors is that under strict medical device manufacturing guidelines, particularly in the clinical environment, vendors need to stick to discussing and training on the markers for which they are cleared. This means training on the familiar three amigos ER/PR/HER2, and usually on only the subtype of breast cancer for which they have been validated and cleared. There is much more to this limitation than can be addressed here, but it clearly limits for good reason clinical IHC software vendors conducting broad training in image analysis.

The other challenge in training pathologists is time. Due to the heavy workload of many pathologists, there is often little time to devote to attendance at a two-day course either onsite or at the scanner vendor location. The histologist and the lab manager may go, but usually the pathologist simply cannot get the time free in his or her schedule.

To respond to this need, Flagship Biosciences is offering a once-a-week, six week image analysis course online, scheduled each Thursday. It is co-led by an image analysis expert and a board-certified pathologist, which makes for a fascinating interaction. Each session only lasts 2 hours (we may cut it to 90 minutes in the future, this is the limit that people can absorb information), and it gives a week in between for attendees to try out the concepts, see what worked and didn’t work, and come back with questions. We will start with basic cell and area measurement, and move toward more advanced, sophisticated software-aided approaches as the courses progress. We hope that after a pathologist and a pathology lab knows how the algorithms work and how to relook at their IHC approaches for quantitation, the next steps will be image analysis validation training.

It will be interesting to see if image analysis becomes something every pathologist is familiar with and can run, or will be the domain of pathology specialists. I hope for the former, but I am betting on the latter.