Munich, Germany – January 31, 2012 – Definiens, the global leader in Health Image Intelligence and Quantitative Digital Pathology, has appointed Martin Stuart, PhD, as its Executive Vice President and General Manager North America and Asian Pacific. In his new role, Stuart will be responsible for expanding the Definiens business in North America and Asia and providing leadership to the sales and field operations.

Martin Stuart, a former Senior Vice President and General Manager of Aperio, is one of the most influential leaders in the Digital Pathology industry. He has more than 25 years of experience in international sales and marketing, specializing in the introduction of new and disruptive technologies. In his previous global sales and marketing position he was a key driver in making Aperio the leading provider of digital pathology, with more than 850 deployed slide scanner systems in more than 30 countries. Prior to Aperio, Stuart was Global Vice President of Sales and Services for Entropia Inc., a desktop grid computing company focused on the Life Sciences market.

“I’m excited to join the market leader in Quantitative Digital Pathology” comments Stuart. “Image analysis is a major driver of adoption and I’m extremely impressed by the results customers are getting by deploying Definiens products and solutions. There is enormous demand for solutions that help pathologists deal with the increasing complexities of their discipline as they support the transition to personalized medicine. I see Definiens as best positioned to address this demand by providing comprehensive decision support solutions.”

“We are extremely pleased to have Martin join Definiens at a time when demand for our products is growing rapidly” says Thomas Heydler, CEO of Definiens.  “His executive experience in the digital pathology business coupled with a profound domain background makes him an ideal fit for our team. With this appointment we will significantly increase both our Life Sciences and our Healthcare Business.”

About Definiens
Definiens is a leading Health Image Intelligence™ company that develops software solutions for biomedical image analysis, data mining and clinical decision support. The company’s software analyzes images from cell-based assays, whole tissue slides and full body scans and allows users to correlate this information with data derived from other sources. By automating analysis workflows and generating new knowledge, Definiens provides pharmaceutical and biotechnology companies, research institutions, clinical service organizations and medical professionals with deeper insights, faster results and better decision support. Harnessing the power of image intelligence, Definiens supports the development of personalized medicine and aims to significantly improve the quality of patients’ lives.
Definiens is headquartered in Munich, Germany, and has offices throughout the United States. Further information is available at www.definiens.com.

Click here to read the blog post introducing the new version.

“Breast cancer experts are cheering what could be some of the biggest advances in more than a decade: two new medicines that significantly delay the time until women with very advanced cases get worse.” (Read the full article: R&D Mag – Life Sciences, Dec 7, 2011, Marilynn Marchione.)

“Roche, Novartis showcase game-changing breast cancer drug data. Roche and Novartis put out new data yesterday on two treatments that promise to fundamentally reshape the way the majority of breast cancer patients are treated. Roche clearly impressed specialists and analysts with the news that pertuzumab combined with Herceptin and chemotherapy checked tumor development for a median of slightly more than six months–from 8.5 months to 12.4 months. And Novartis’s Afinitor demonstrated a four-month delay in disease progression among metastatic patients.” (Read the full article: FierceBiotech News, Dec 8, 2011, John Carroll.)

“The dual HER2 antibody therapy is showing promise but is still in clinical trials to determine who are the best HER2 patients to treat and in what setting,” commented Ben Ho Park, MD, PhD, of Johns Hopkins University, in an email to MedPage Today and ABC News. (Read the full article: MedPageToday, Dec 08, Ed Susman)

Definiens invites you to Munich for the 3rd International Definiens Symposium 2012. Hear about cutting-edge biomedical image and data analysis, groundbreaking research and exchange experiences with other Definiens users. In addition to our dynamic plenary sessions, and fruitful networking breaks, this year we will be adding extensive hands-on workshops to our lineup.

Abstract submission: before February 28
Early bird registration: before March 31

We would be delighted to welcome you in Munich.
Best regards,
The Definiens Team

In a recent article, GenomeWeb News reports that Novartis Molecular Diagnostics focuses on companion diagnostics as key strategic direction. By “… moving into the companion diagnostics space, Novartis has joined a growing list of firms that believe that market could become a major business opportunity, though it may take several years for it to happen. Like its Swiss competitor, Roche, Novartis has expansive pharmaceutical programs that lend themselves to companion diagnostic efforts” concludes Tony Fong, the author of the article.

It is going to be interesting to see what kind of companion diagnostics these efforts will yield. Don’t be surprised if image-based diagnostics will play an essential role.

In 2011, the number of articles in peer-reviewed journals published by scientists using Definiens technology increased about threefold compared to 2010. As impressive as the dynamic increase is the wide variety of image analysis tasks that are successfully solved with Definiens technology.

Visit our publication archive to learn more.

Particularly noteworthy publications from 2011 include:

Schramek et al., Nature Genetics 43: 212-9
Nikić et al., Nature Medicine 17: 495-9
Elachouri et al., Genome Research 21: 12-20
Varela et al., PNAS Early edition, August 24
Wilson et al., Journal of Cell Biology 193: 935-51
Courties et al., Arthritis and Rheumatism 63: 681-90
Leeper et al., Biomaterials 33: 907-15
de Jesus et al., Aging Cell 10: 604-21
Blanchet et al., FASEB Journal, Epub ahead of print, September 13
Beck et al., Science Translational Medicine 3: 108ra113 (see earlier blog entry)

I couldn’t agree more. We at Definiens are convinced that this is the way to go and hope to make going it a little easier with the introduction of the Definiens Image Miner. While not available yet at the time Beck et al. performed their breaking work, it has been designed to make similar things happen. And it builds on the same  sophisticated image analysis technology Becks C-Path (computational pathologists) relies on – Definiens Cognition Network Technology.

Both the article itself and the insightful introduction by David Rimm are recommended reading for anyone interested in how quantitative image analyis can be combined with powerful data mining to transform pathology. Open-minded pathologists will embrace their computational colleague and should keep on teaching him. The rewards may well include better tools to fight cancer.

What can Tissue Studio do for you?
Who is Tissue Studio designed for?
Why is Tissue Studio the solution of choice?

Please watch out for forthcoming entries to learn more on new functionality of the new version or have a look at the recordings of the introductory webinar.

Who is Tissue Studio designed for?

The short answer is: Definiens Tissue Studio is designed for

• anyone analyzing tissue samples
• in translational research
• to identify new predictive or diagnostic biomarkers.

In order to make this answer a little more comprehensive let’s look at each of these points a more closely.

• The tissue sample can originate from any solid tissue; the digitized image to be analyzed can be captured with any scanner or microscope (in any standard file format); the tissue can be stained with H&E or IHC and immunofluorescence imaging is supported; whole slide scans, fields-of-view and TMAs can be analyzed.
• While translational research in oncology represents the most prominent field of application, Definiens Tissue Studio is a valuable resource in basic research, preclinical or clinical trials and helps to address questions in toxicology, immunology, and diabetes research among others.
• Definiens Tissue Studio is typically applied in biomarker development and assay development and can very effectively be used to correlate quantitative biomarker expression profiles and detailed morphological fingerprints with external data such as patient outcome (or genetic information, blood parameters, proteomic results…).

Regardless of the actual application Definiens Tissue Studio is really designed for a specific mindset. If you are striving for truly quantitative and accurate research and aim at delivering consistent and robust results Tissue Studio is designed for you.

What can Tissue Studio do for you?
Who is Tissue Studio designed for?
Why is Tissue Studio the solution of choice?

Please watch out for forthcoming entries to learn more on new functionality of the new version or have a look at the recordings of the introductory webinar.

Why is Tissue Studio the solution of choice?

The two most important reasons are the following: Definiens Tissue Studio opens new dimensions in quantification. And it is easy to use.

The benefits of ease-of-use are pretty obvious: Straightforward interface and intuitive configuration help you to get to your results sooner. The full appreciation of the importance of truly quantitative readouts requires more imagination (and an example may help). However, to really value what Tissue Studio can do for you, I want to emphasize that quantitative results represent just one of five hallmarks of successful tissue analysis:

• Quantitative readouts
• Accuracy
• Consistency
• Robustness
• Speed

It is fairly easy to optimize some of these at the expense of others. Pathologists are very good at providing a fast assessment of tissue samples and their vast background knowledge yields very high robustness (they are able to deal with different tissue types, staining intensities and many kinds of abnormalities and artifacts). However, intra- and inter-observer variability can threaten consistency and quantitative measurements are typically very challenging (and certainly compromise speed, if possible at all). On the other hand, computer-based methods easily generate consistent results and also have little trouble providing quantitative readouts. Unfortunately, this is of very limited value if accuracy and robustness are impaired.

Definiens Tissue Studio is the leading solution for quantitative digital pathology because it uniquely combines the five virtues of successful tissue analysis. The latest release provides improvements in all these dimensions. Importantly, there is no change regarding one major characteristic of Tissue Studio: It remains as easy to use as ever.

What can Tissue Studio do for you?
Who is Tissue Studio designed for?
Why is Tissue Studio the solution of choice?

Please watch out for forthcoming entries to learn more on new functionality of the new version or have a look at the recordings of the introductory webinar.

What can Tissue Studio do for you? Here’s an example: You have a large set of image data; say tissue micro array (TMA) cores from patients with esophagogastric cancer stained for HER2. After very limited configuration, Tissue Studio automatically:

• identifies regions of interest on each core
• detects nuclei and membrane within each region of interest
• separates individual cells
• measures staining intensity of the membrane and membrane closure per cell
• computes a HER2/neu score per individual cell
• counts the number of cells with a HER2 score of 0, 1+, 2+ and 3+, respectively
• uses these counts to determine the HER2 score for each core
• provides comprehensive readouts including quantitative data on all of the above

Similar readouts can be generated to answer your specific question. Definiens Tissue Studio readily analyzes  image data from any solid tissue and supports IHC, H&E and IF.

Last week, Definiens released a new product portfolio designed to advance biomedical research and tissue-based biomarker development with solutions for image analysis and data mining. It includes updated versions of Definiens Tissue Studio, Definiens Developer XD, as well as a completely novel component, Definiens Image Miner.

Learn more on one of the following occasions:

• Definiens Product launch webinar (October 26 – see the recorded webinar on YouTube)
• Definiens Workshop at Pathology Visions (October 30)
• Definiens Tissue Studio 3 webinar (November 9 – see the recorded webinar on YouTube)

The Definiens team is excited to introduce you to new opportunities in Quantitative Digital Pathology.

The technology in Definiens’ recently released product suite will provide high accuracy in automatically identifying relevant structures of interest and specific morphology in histology, resulting in a detailed phenotypic fingerprint and biomarker expression profile on a cell-by-cell basis. The large set of descriptors can be correlated against therapy response or patient outcome with the goal of identifying new types of biomarkers of predictive or prognostic value.

Definiens Image Miner™ 1, the novel technology component in this product portfolio, closely integrates data mining with image analysis to accelerate biomarker research. The data mining functionality is based on the same revolutionary Cognition Network Technology used in Definiens’ well-established image analysis solutions. Definiens Image Miner™ 1 provides a substantial productivity increase when profiling tissue probes for clinically or diagnostically relevant differences in morphology or biomarker expression. Development and quality control are supported by seamless links between data points and the visual inspections of associated regions in the tissue“We expect the tight integration of our new data-mining engine with the significantly updated image analysis solutions to substantially increase productivity and assay quality in tissue-based biomarker development,” says Dr. Martin Baatz, Vice President of Marketing at Definiens. “We consider this a major step on the way to turning pathology into a quantitative discipline.”

Also included in the new portfolio is Definiens Developer XD™ 2, the most powerful development environment for automated image analysis that addresses a wide scope of functions in biomedical image analysis with unprecedented depth and accuracy. Developer XD™ 2 will be the solution of choice for highly advanced or customized analysis tasks of digital tissue slides. This updated version addresses a series of requirements suggested by the user community including very large data processing and machine learning functionality.

The most popular product of the suite is Definiens Tissue Studio® 3, which is an updated version of the company’s leading Image Analysis Solution for Quantitative Digital Pathology. It combines highly detailed quantification of tissue specimen with a straightforward and fast out-of-the-box configuration workflow. New features include an improved detection of regions of interest, classification of nuclear morphology and an angiogenesis module.

After exploring the new Definiens Tissue Studio® 3 during the early access program, Mark Lloyd, Supervisor of Analytical Microscopy Core Facility at Moffitt Cancer Center, says: “I can be difficult to please regarding image analysis of histological samples, but this is the best commercial product I have used to date. This includes workflow and usability, as well as function and flexibility.” And Dr. Tom Nifong, VP CLIA Services at Metamark Genetics, adds: “The Composer Technology for automatic detection of regions of interest performed great. It was able to identify tumor, stroma and artifacts in my fluorescence samples. I was really impressed by the improvement in accuracy and speed of the nucleus detection. Fantastic job!”

For more information about the new products, please visit quantitative-digital-pathology.definiens.com or register for the launch webinar. The products will also be presented at the upcoming International Definiens Symposium at the Moffitt Cancer Center, FL, Oct. 17 and 18.

In recent years, Definiens has generated a large footprint over the entire bandwidth of biomedical applications, specifically in the field of Quantitative Digital Pathology and Biomarker Research. Definiens Tissue Studio® has already been established as an industry standard. Now we are embarking on a new frontier with the introduction of Definiens’ next generation of products. Existing products for image analysis will be significantly improved, with a focus on tissue-based biomarker research, providing high accuracy in automatically identifying relevant structures of interest and specific morphology in histology. The result is a detailed phenotypic fingerprint and biomarker expression profile on a cell-by-cell basis. In addition, a completely new component will be added to Definiens suite of products, which will allow users to leverage the enormous value of the received measurements and data. This component will closely integrate image analysis with data and image mining. An illustration of this component is the correlation of a large set of descriptors against therapy response or patient outcome in order to identify relevant biomarkers of predictive or prognostic value.

Click here to learn more.

Register today to ensure your seat at the leading event for Definiens Image Analysis users around the world in Cancer Research, Pharmaceutical & Biotech, Clinical & Academic settings.

Housing will close September 27th, for special discounted rates. If you want to contribute a poster, please send an email to academy@definiens.com by September 16th.

The Definiens Team is looking forward having you join us for this event.

Two weeks ago, the FDA released a new draft guidance that should be of interest to anyone working in the digital pathology field to or anyone interested in companion diagnostics. It could be even more important to those not interested in companion diagnostics if they are into drug development. I’ll briefly summarize some main points but the draft clearly deserves detailed reading.

First, the FDA provides important clarifications: “An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product” because its use “allows the therapeutic product’s benefits to exceed its risks”.

In such cases the therapeutic product is considered to depend on the use of the respective diagnostic test. The FDA emphasizes that such dependencies have become more common and encourages the pharmaceutical industry to actively embrace and advance this development. They suggest contemporaneous development of therapeutic product and companion diagnostic and “expect that the therapeutic sponsor will address the need for an approved or cleared IVD companion diagnostic device in its therapeutic product development plan.” FDA intends to review “diagnostic device submission within the context of, or in conjunction with, its corresponding therapeutic product” and “intends to issue approvals or approval and clearance for both products at the same time”.

Very important is the following statement: “…FDA does not believe it may approve a novel therapeutic product or new therapeutic product indication for use with an IVD companion diagnostic device if the IVD companion diagnostic device is not approved or cleared for that indication.” Possible exceptions to this general rule are discussed but even for these “FDA expects that an IVD companion diagnostic device that is intended for use with the therapeutic will be subsequently approved or cleared through an appropriate IVD device submission.”

Wow. Steve Potts, CEO of Flagship Biosciences, summarizes his conclusion on the matter succinctly:

“Failure/lack of test approval = no therapeutic product approval”

He provides a dramatic estimation of how high the stakes may be. His numbers have 9 digits. Pharmaceutical executives may want to think harder about their companion diagnostics programs before losing billions.

There’s clearly interesting times ahead for anyone into companion diagnostics.

The annual Definiens Symposium is the premier forum for Definiens users and developers from around the world to present their latest research, techniques and workflows in life science image and data analysis. Participants come from research institutions, bio-pharmaceutical companies and the healthcare sector. The 2011 Definiens Symposium will be an ideal opportunity to share the latest ideas in state-of-the-art image analysis and to meet international experts from the Definiens community. A social networking event will take place in Tampa’s latin quarter, Ybor City, on Monday evening. Transportation between the Symposium venue and the evening event will be arranged.

When: October 17-18, 2011

Venue: Venue: H. Lee Moffitt Cancer Center and Research Institute, Vincent A. Stabile Research Building, 12902 Magnolia Drive, Tampa, FL 33612, USA

Registration: Click here to register or to learn more.

Sessions will include:
Biomarker Development and Validation
Basic Research and Drug Discovery
Toxicity and Efficacy Studies
Clinical Diagnostics