From the editor: While it has long been suspected that digital pathology image analysis may have great promise in assisting in the accuracy of diagnosis / prognosis of disease, very few studies have actually proven this.

Dr. Guenter Schmidt et al. have recently presented their findings in a study to compare manual H-score evaluation (Dako Herceptest) of esophagogastric TMA cores as compared to an algorithm derived at Definiens, using Definiens Developer™ software.

The findings are quite stunning: Kaplan-Meier Analysis revealed a significant (DFS: p < 2.4×10-6; OS: p < 2.5×10-7) prognostic value for the two groups generated by data mining image analysis results, whereas the visually assessed score was not significant (p>0.1).

Kaplan-Meier curves for prognostication of Esophageal cancer patients using manual evaluation of Dako Herceptest (left) and Definiens image analysis (right).

Schmidt G, Binnig G, Feuchtinger A, Walch A

Identification of Prognostic Factors using Quantitative Image Analysis of HER2 Expression by Immunohistochemistry (IHC) in Adenocarcinoma of the Esophagogastric Junction

Background: Since adenocarcinoma of the oesophagogastric junction is known to show human epidermal growth factor receptor 2 (HER2) overexpression we investigated the potential of IHC stained cancer tissue to provide information about disease free (DFS) and overall survival (OS) times. We compare the prognostic value of a visually assessed scoring algorithm derived from Dako HercepTestTM with results provided by data mining information from quantitative image analysis.

Methods: Three tissue microarrays (TMAs) comprising 391 cores from tissue samples of 150 patients were analysed. After IHC staining with HER2 antibody the TMAs were scanned with Zeiss MIRAX slide scanner (20x objective). Fully automated image analysis using the Definiens Cognition Network Technology® segmented and classified cells, nuclei, cytoplasm and membrane objects, and determined on a per cell basis shape, texture and color properties. Those were correlated with known DFS/OS times using a multivariate regression analysis within the R statistical software. Based on this predictive model, the patient population was divided in one group with good and one with poor prognosis by imposing a threshold on the predicted survival times. The corresponding groups obtained by the pathologist scoring were HER2 score 0, 1+, 2+ versus HER2 score 3+.

Result: Kaplan-Meier Analysis revealed a significant (DFS: p < 2.4×10-6; OS: p < 2.5×10-7) prognostic value for the two groups generated by data mining image analysis results, whereas the visually assessed score was not significant (p>0.1).

Conclusion: Data mining quantitative image analysis may provide a more accurate evaluation of HER2 evaluation than a visual assessment of tissue samples. The quantification of HER2 overexpression by image analysis may be also highly valuable for the prediction of anti-HER2 therapy in combating this cancer type. (Presentation given at the 52nd Symposium of the Society for Histochemistry, Prague, Sept 1 – 4)

From Flagship Bio:

New office offers local access for Cambridge biotech companies to pathologist, technician, scanning and image analysis

Flagstaff, AZ – September 13, 2010 – Flagship Biosciences LLC, a provider of digital pathology services, has opened a local digital pathology office in the Boston suburbs to better support the growing demand for local quantitative histopathology services. The office is staffed by a board-certified pathologist, a scanning and image analysis technician, and digital pathology scanners.

“While digital pathology has the remarkable ability to remove geographic barriers, Flagship’s Cambridge area customers have expressed interest in local access to quantitative histopathology services,” said Dr. Frank Voelker, DVM, DACVP, who leads the new office. The ability for pharmaceutical researchers to sit down in person and discuss study designs and image analysis approaches in tissue with a local pathologist is very helpful. While our customers can view all of our tissue results remotely on each slide via a web-based portal, there is still no replacement for individual interaction in person.  Many of these studies contain hundreds of glass slides, and being able to teach and share information with our Cambridge area customers can be very useful.”

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Check out Definiens’ latest advert for Definiens Tissue Studio 2.0.

The leading digital pathology image analysis solution – just got better.

From the editor: Amanda Lowe, Principal at Digital Pathology Consultants, LLC, published a very well written article on the adoption of digital pathology (below). While Amanda points out that the “timeline” of future widespread utilization of digital pathology is widely debated, we can be sure that digital pathology is here now, and will continue to proliferate. This is validated by Philips, Siemens, GE, and recently Roche (who recently acquired BioImagene) jumping into the picture. These companies would not be investing major resources if they didn’t all feel that this was a viable place for them to be.

Is the slower than desired uptake generational? Is it lack of standards? Is it lack of regulation? Work flow integration? All of the above? Please feel free to comment below on your thoughts as to what it will take to increase the rate of adoption of digital pathology.

One thing is for sure:  As more and more health care institutions adopt digital pathology and show ROI, other institutions will be forced to follow.

The Digital Transformation of Pathology

When does the future become reality?

By Amanda Lowe

From: AdvanceWeb.com

From: Advance for Administrators of the Laboratory

Digital Pathology Roundtable Discussion

Vendors respond to questions about the state of digital pathology today.

• Cathy Boutin, marketing manager, Cambridge Research & Instrumentation Inc. (CRi)
• Gene Cartwright, CEO, Omnyx
• Peter Duncan, director, Business Development, Clinical Diagnostics, Definiens
• Ole Eichhorn, chief technology officer, Aperio
• Michael D. Harris, development director, GlobalMedia Group LLC
• Philippe Nore, international business leader, Ventana Medical Systems Inc.
• Ajit Singh, PhD, chief executive officer, and Robert Monroe, MD, PhD, chief medical officer, BioImagene (acquired by Ventana Medical Systems Inc., a member of the Roche Group)

What is the industry doing to improve interoperability in digital pathology? What still needs to be done?

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From DarkDaily:

From the editor: Very interesting article – what got my attention quickly was the paragraph where Dr. Tan discusses how “the current reimbursement structure for diagnostic testing in the U.S. does not sustain an adequate return on investment for the developers of companion diagnostics…” This seems to correlate to the fact that there are a dearth of companion diagnostics that have been developed.  A full rundown of the current companion diagnostic tests (and a great article about this topic) can be found here.

Advanced histology staining equipment will capture a greater market share

There’s good news for anatomic pathologists in the forecast from one expert watching the U.S. market in equipment for clinical diagnostics. According to Winny Tan, Ph.D, a Senior Analyst with Frost & Sullivan, the increasing rate of cancer incidence in the U.S. will drive robust growth in tissue-based diagnostics.

She predicts that revenues from that segment will more than double by 2016, growing from the $1.029 billion in 2009 to $2.278 billion in 2016. Tan made her predictions in an article in the May 15, 2010 issue of Genetic Engineering News.

“The tissue diagnostics [equipment] market contains two submarkets with distinct market characteristics: the pre-analytical and routine staining market and the advanced staining market,” Tan wrote.

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From Genomeweb.com

NEW YORK (GenomeWeb News) – Beckman Coulter announced today that Chairman, President, and CEO Scott Garrett resigned from the firm, effective yesterday.

The Orange County, Calif.-based diagnostics and research products firm has appointed J. Robert Hurley as interim president and CEO and plans to search for a full-time successor to Garrett. Hurley has served as senior VP of human resources and chairman of Beckman Coulter Japan. He’s been with the firm since 2005 and recently led the integration of Olympus’ lab-based diagnostics business into Beckman Coulter.

Glenn Schafer, the firm’s lead independent director, has been appointed non-executive chairman.

Beckman Coulter did not provide the reasons for Garrett’s resignation.

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From: MedpageToday.com

WASHINGTON — The Food and Drug Administration turned down a request for accelerated approval of Roche-Genentech’s trastuzumab-DM1 drug for the treatment of HER2-positive breast cancer.

The FDA concluded that the supporting data for trastuzumab-DM1 did not meet the Biologic License Application (BLA) Standard for accelerated approval because all available treatment choices for metastatic breast cancer — irrespective of HER2 status — had not been exhausted.

Roche had requested accelerated approval on the basis of a single-arm phase II study showing that trastuzumab-DM1 led to tumor responses in a third of patients with advanced HER2-positive breast cancer. Patients in the trial had received an average of seven prior regimens.

An ongoing phase III study will continue as planned. In a statement from the company, Roche officials said they expect a global regulatory submission for trastuzumab-DM1 by the middle of 2012.

Trastuzumab-DM1 is an antibody-drug conjugate, also known as an armed antibody. Conjugate links trastuzumab with the chemotherapy agent DM1, using a stable linker that keeps the agent in one piece until it reaches its target cancer cells, according to a Roche statement. The antibody is designed to bind and penetrate HER2-positive cancer cells and then release the active drug inside the cells to destroy them.

Roche is headquartered in Basel, Switzerland. Genentech, based in San Francisco, Calif., is a unit of Roche.

From: LeicaMicrosystems.com

New Integrated Solutions for Capturing, Managing, and Analyzing Virtual Data

Wetzlar, Germany. With its unprecedented scanning speed and top-quality on-screen imaging, the Leica SCN400 Slide Scanner has already set new standards in virtual imaging. Through the acquisition of Genetix Ltd. at the beginning of this year, Leica Microsystems is now able to considerably expand its solutions offering. With the software solutions Ariol and SlidePath, Leica Microsystems now adds the ability to store, manage, analyze, and report on digital images created with the Leica SCN400 Slide Scanner or the Leica DM6000 B Research Microscope.

High throughput solution for in vitro diagnostics: Ariol on the Leica SCN400

Combining Ariol with the Leica SCN400 Slide Scanner provides a complete solution for labo­ratories dealing with a high volume of slides. The product is a high throughput solution for biomarker assessment.

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