Today, Dr. Marilyn Bui and Mark Lloyd from the Analytic Microscopy Core at the Moffitt Cancer Center presented the results of their findings from a feasibility study they did with Definiens Tissue Studio. The purpose of the study was to see if they could achieve parity with current pathology best practices for the assessment of predictive and prognostic biomarkers in breast cancer tissue.

Peter Duncan of Definiens also underscored their results by presenting a recent study done with the Helmholz Institute in Munich, Germany. The study compared Her2 analysis in stomach cancer using Definiens with manual evaluation. The results were quite compelling and were demonstrated via Kaplan-Meier survival analysis; where the degree and statistical significance of the patient stratification (disease free survival time) was better using the Definiens approach for digital image analysis of histology slides.

Watch the webinar to learn more (for best results, click 1080p to watch the videos in high definition):

Results:

More from the webinar:

http://www.youtube.com/definienslifetv

From Financial Times

The US Food and Drug Administration has called for regulation of companies selling personal genetic tests after one laboratory mixed up the results of nearly 100 clients.

The Silicon Valley company 23andMe, which uses personal genetic tests to predict hereditary diseases, last week said that it gave 96 clients inaccurate information after a lab error. The mistake left one client believing that her son was not her own, while another was led to understand that she was of African origin while the rest of her family is Caucasian.

The gaffe raised questions about the ethics and safety of personal genetic testing – a nascent industry – as doctors and advocates warned that inaccurate results could prompt patients to make potentially life-threatening changes to their medications. “There is a real risk in these mix-ups,” said Jesse Reynolds of the Center for Genetics and Society. “Incorrect data can have serious implications, such as inaccurate beliefs about the potential to develop serious diseases and what medications one should take.”

The company declined a request for interview but said on its website: “We fully realise the gravity of this incident.”

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From Next Generation Pharmaceutical

By Peter Duncan, Definiens

Let’s start with what we know. For years, the state of pharmaceutical drug development has been in decline in terms of new molecular entities or biologics that are clearing FDA approval.

Most agree that targeted therapies are the key to the future success of drug development, especially with respect to cancer treatments. However, currently we have just a handful of companion diagnostics for just a handful of targeted therapies, with many of these companion diagnostics far from reaching their mark of achieving desirable false positive or negative results (as recently reported in the New York Times “Cancer fight: Unclear Tests for New Drug”). The majority of patients who are administered targeted therapies still do not respond in the way that we would hope. Pharmaceutical R/D spending, while much of it is becoming outsourced, has actually increased inversely to the success of clinical development programs.

Being Disruptive Will Only Get You So Far

I have been watching life science technologies evolve for about 20 years. Every 6 years or so, a new disruptive technology takes hold. I am thinking about technologies like gel-based DNA sequencing, reverse transcription PCR, 96-well DNA capillary sequencing, MALDI TOF, DNA microarrays, and now next generation DNA sequencing. What I have seen in the previous examples (with exception of reverse transcription PCR), is that the closer that these technologies get to producing data that has real clinical utility, the harder it is for the technology to be used in a clinical setting, including drug development. This is because most of these technologies are too complex, too expensive, take too long to prepare samples, and often give too much information to use in a routine clinical environment.

Digital Pathology – the New Kid in Town

For drug developers that follow the latest and greatest technology trends, there is a “new kid in town.” Digital pathology was originally introduced as a way for pathologists to teach, collaborate, and review cases remotely. It has also produced a means to view, store, and analyze images. Recently, digital pathology has been implemented into the routine clinical diagnostic setting. But can digital pathology really make a significant future impact on drug development and clinical diagnostics?

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This is a super summary of why digital pathology will have a major role regarding diagnostics in the years and decades to come. Of note, Aureon’s digital pathology image analysis is based on Definiens image analysis. Additionally, CLIA diagnostic service labs like Clarient are also using Definiens for processing thousands of tissue slides per day. Digital pathology will be vital going forwards, but even more vital is accurate assessment of the information contained in the tissue, and Definiens is the only company that focuses solely on this aim. In other words, Definiens is the only company that focuses on the “app” for digital pathology image analysis.

From Seeking Alpha

The Human Genome Project (HGP) was a 13-year project coordinated by the U.S. Department of Energy and the National Institutes of Health in cooperation with genetic bioscience giants Celera Genomics (CRA), Incyte (INCY), and Human Genome Sciences (HGSI). The Human Genome Project aimed to tell us what the sequence of the average person’s genetic code is “supposed” to be, and gave the necessary information for publicly funded research as well as for-profit research to begin understanding how the differences between individuals DNA affect health and disease. Indeed, this information gave rise to the concept of “personalized medicine”, which seeks to use precise genetic information about individual patients to custom tailor their mode of therapy for a disease. This concept of personalized medicine has fueled the growth of multi-billion dollar companies like Myriad Genetics (MYGN), Sequenom (SQNM), Illumina (ILMN), and Affymetrix (AFFY).

We have been hearing about the promise of “personalized medicine” for over a decade now, but what has come of it? It has long been predicted that diagnostics based on genetic information brought forward by the human genome project would bring more targeted and cost-effective therapies. However, to date, almost 20 years later, there are only a few examples that have come to fruition. In general, large pharma has been slow to implement useful companion tools to apply the concept of personalized medicine to their clinical drugs. The idea seems simple: Along with the drug, create a companion diagonostic that will determine the correct course of therapy for the patient. More specifically, the companion diagnostic will predict ahead of time whether or not patients will respond to the drug.

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This is just amazing stuff. Watch Definiens XD in action first locate the nuclei; determine positive and negative Ki67 nuclei; locate the small intestine crypt; fill the crypt and “cut” the top to establish the area that can be measured.

This was a pre-clinical study done by Novartis to use both Ki67 positive nuclei as well as the area of the small intestinal crypts in a rodent model as part of their FDA submission packet. Imagine doing this manually across thousands of animal tissue samples? Ouch!

This is just a testament to how powerful Definiens is – you really can measure anything in an image.

Watch the video:

Definiens Digital Pathology Webinar Series:

Image Analysis as a Tool for Prognostic and Predictive Biomarkers in Breast Cancer – How Reliable Is It?

June 30th, 11am EDT (4pm GMT)

Register: https://www2.gotomeeting.com/register/434138978

In this talk, Dr. Marilyn Bui and Mark Lloyd of the Moffitt Cancer Center will discuss their assessment of Definiens Tissue Studio for analysis of prognostic and predictive biomarkers in breast cancer.

The agenda for the webinar will be:

● Current standards in IHC and pathology
● Advantages of automated image analysis
● How Definiens Tissue Studio is used for digital pathology image analysis
● Case study comparing Definiens Tissue Studio analysis results with “gold standard” immunohistochemistry Her2 and ER best practices.
● Results

Speakers:

Dr. Marilyn Bui – Scientific Director, Analytic Microscopy Core, Moffitt Cancer Center, Tampa, Florida

Mark Lloyd – Staff Scientist, Analytic Microscopy Core, Moffitt Cancer Center, Tampa, Florida

Yesterday at the Definiens Digital Pathology Webinar Series, Sven Perner and Theresia Wilbertz from University of Tuebingen presented a compelling study regarding SOX2 expression analysis in NSCLC, comparing two independent NSCLC cohorts. Their findings indicated that:

1. Elevated SOX2 expression is found in patients with squamous NSCLC, and correlated with better prognosis
2. Elevated SOX2 expression in these cohorts correlated with elevated SOX2 copy numbers as observed by FISH

Please note that the webinar is available for watching in HD – just click one of the HD options in the lower right. You can then click the “full screen” button and watch the webinar clearly.

By Peter Duncan

Director, Marketing and Business Development Clinical Diagnostics
Definiens
June 8, 2010

Dr. Martin Baatz of Definiens takes in a 3D movie about Erbitux mechanism of action

BOSTON – I just returned from ASCO 2010 in Chicago after spending 4 days there. I was there during the exhibitor setup and for the entire conference. The following are thoughts from the perspective of a enabling technology provider focused on image analysis of digital pathology and non-invasive images (not a drug developer):

1. While there were many plenary talks and sessions dedicated to the discussion of personalized medicine, imaging, biomarkers etc. as key aspects of drug development, the traffic at most of the technology providers’ booths that can actually help enable this was light. This can only be attributed to the fact that the average ASCO attendee is a treating oncologist and seems to be relatively disengaged from diagnostic development  and / or translational research. This is tragic, because the future of drug development for targeted therapies will absolutely depend on accurate companion diagnostics.

While there are large numbers of oncologists that are active in the study, validation, and implementation of diagnostics, it would help progress towards treating cancer if many more oncologists were engaged in this area on behalf of their patients. This would cause pharma to become more active in diagnostic / drug co-development to meet this demand. I thought ASCO could have done a better job at facilitating interaction between ASCO attendees and companies like Definiens who have a major contribution to play with respect to the development of more accurate diagnostics; the understanding of underlying cancer biology; and thus, the development of more effective cancer therapies.

2. Dr. Martin Baatz of Definiens and I took a long stroll around the exhibit hall and ran into a sales rep from a leading pharmaceutical company. The sales rep was exceedingly proud of a new drug that the company had released, with their final parting comment, “No surprises so far!” Both Martin and I found this rather amusing, that the good news is that there is no bad news!

3. The third major observation that was made was that pharmaceutical companies spend massive amounts of money with respect to marketing and state of the art exhibit booths (and those cool TV adverts with all of the disclaimers); essentially taking a commodity-based approach to their products which took years, billions of dollars, and cutting edge science to develop. From the giveaways; to mini cafe’s within the exhibit booths; to the models – it was stunning that the main goal for pharma companies at ASCO  was to “cater” (literally) to the emotion of the oncologist / attendee vs. promoting the science behind these drugs.  This statement seems a bit over reaching, because there were actually plenty of presentations and material that did get into the scientific aspects of drugs. But from my point of view, this information got buried in all of the glitz and ASCO looked like a competition of who had the coolest and biggest exhibit booth, vs. a competition of who actually has the best drugs.

What I would like to see at future ASCOs is the opportunity for companies such as Definiens to be able to interact with drug developers to discuss possible areas of synergy, as well as for more oncologists to actively engage themselves in how diagnostics can enable them to be more effective in the treatment of their patients. At the end of the day, it is really about how people get together to work on this problem, and conferences like ASCO are in the perfect position to facilitate this.

From NYTimes.com

CHICAGO — Using two opposite strategies, one focused and one broad, scientists say they have made progress in taming two of the most intractable types of cancer.

The focused approach shrank tumors significantly in a majority of patients with advanced lung cancer marked by a specific genetic abnormality.

Even though the clinical trial was small (just 82 people, with no control group), the results were considered so striking for such sick patients that the study will be featured Sunday at the main session of the annual meeting of the American Society of Clinical Oncology here.

“This is a phenomenal example of finding the right patient and the right drug very early on,” said Dr. Pasi A. Janne of the Dana-Farber Cancer Institute in Boston, who was involved in the trial.

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From Science Daily

Intravenous delivery of a cancer-targeting virus is successful in destroying cancer cells that have spread throughout the body, according to research to be presented at the American Society of Gene & Cell Therapy 13th Annual Meeting.

A recent study tested 23 patients with metastasized colorectal, skin, ovarian and lung cancers. Patients received a single intravenous treatment at one of five dose levels. In 75 percent of patients who received the highest doses, the therapy reached and replicated within tumors throughout the body, effectively stopping cancer growth. Some patients on the lower doses also saw disease stabilization.

All dose levels were well tolerated, with patients experiencing only mild side effects, such as flu-like symptoms.

“This is the first time that we’ve been able to treat patients intravenously and had proven success in targeting and destroying metastatic cancers in the body with an armed oncolytic virus product,” said David H. Kirn, MD. “This opens up a whole new world of systemic approaches to therapy.”

Gene therapy has been used before to fight cancer, but previous treatments were limited to localized tumors. Intravenous delivery allows for whole-body treatment.

Kirn said the study opens the door to retest existing genetic or protein treatments that had previously been limited to patients with localized tumors. Researchers will begin a Phase III trial later this year in patients with liver cancer.

Definiens, the number one Enterprise Image Intelligence® company, will present its image analysis software for use in clinical trials and translational research at this year’s annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, from June 4th to 8th. Definiens software enables personalized medicine by providing oncology researchers and drug developers with deeper insights into the underlying biology of cancer from the analysis of digital pathology and non-invasive medical images.

Definiens digital pathology image analysis software allows pathologists to accurately identify, quantify and interpret biomarkers and cellular morphology in tissue samples on a cell-by-cell basis. With Definiens Tissue Studio™ researchers have the ability to make earlier, more informed drug prioritization decisions by validating drug-target interaction as well as the measurement of surrogate biomarkers for toxicity. Additionally, Definiens Tissue Studio™ provides automated biomarker and morphological analysis for translational research in retrospective or prospective settings.

Definiens radiology software supports the volumetric analysis of lesions and organs over time. A recent study conducted with Merck & Co. demonstrated that volumetric insight, gained with Definiens software, can provide earlier indications of a candidate compound’s efficacy, potentially shortening clinical trials and providing substantial cost savings.

ASCO meeting attendees who would like to learn more about how Definiens software supports personalized medicine and translational research are invited to visit booth 13140.

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From Microsopy News

To diagnose cancer reliably, doctors usually conduct a biopsy including tissue analysis – which is a time-consuming process. A microscopic image sensor, fitted in an endoscope, is being developed for in vivo cancer diagnosis, to speed up the detection of tumors.

Early detection is the key to the successful treatment of cancer. But not every lump turns out to be a malignant tumor. To find out whether cancerous cells are present, doctors usually conduct a biopsy and examine the removed tissue under the microscope. This process is not only very stressful for the patient but also highly time consuming.

Research scientists at the Fraunhofer Institute for Photonic Microsystems IPMS in Dresden are aiming to considerably speed up cancer diagnosis. They have developed a microscope head with a diameter of just eight millimeters which can optically resolve and magnify tissue cells measuring just 10 to 20 micrometers. Fitted in the tip of an endoscope it will be used for in vivo cancer diagnosis, inserted in the body as in a minimally invasive surgical operation. The scientists envision that the MEMS (micro-electro-mechanical system) microscope head will eliminate the need for biopsies. Diagnosis in real time would enable doctors to decide on the necessary course of treatment more quickly.

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Recentin is an inhibitor of VEGF. I wonder had AZ used digital pathology for biomarker and morphological analysis whether they would have been better able to subtype patients who would be more likely to respond.

From Reuters

AstraZeneca dropped plans to file experimental cancer drug Recentin as a first-line treatment for colon cancer on Friday after disappointing results from a second pivotal clinical trial with the medicine.

Many investors had been sceptical about the drug’s prospects in this area after it failed in the previous study.

The latest Phase III clinical trial, known as Horizon II, showed that while Recentin combined with chemotherapy helped patients live longer without their disease progressing, there was no improvement in overall survival compared with chemotherapy alone.

The drug, also known as cediranib, had already flunked another study comparing it head-to-head with Roche’s (ROG.VX: Quote, Profile, Research, Stock Buzz) blockbuster Avastin in March.

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