Biomarker Commons: News

Cepmed Launches Online Personalized Medicine Portal

Biomarker Commons Newsbot — Thu, 23 Feb 2012 07:12:52 +0000

The Centre of Excellence in Personalized Medicine (Cepmed), announced recently that they have launched a web-based Personalized Medicine Portal for Canadians and joined DNA Direct by Medco's Genomic Medicine Network (GMN).

Cepmed's Personalized Medicine Portal (Portal) provides information and decision making tools that will help patients understand how genetic testing can be used to inform treatment decisions and enable better communication between patients and providers. The Portal, available at www.cepmed.com, provides information about access to specific genetic tests in each Province. "Many of the stakeholders have told us that there is a dearth of reliable, evidence based information concerning personalized medicine tests. A centralized source of information about which tests exist, who should take them and how they should be interpreted is what we are offering through our partnership with DNA Direct by Medco. We believe this resource will contribute to improved patient outcomes and savings to the health care system." - Dr. Clarissa Desjardins - CEO, Cepmed.

According to the Personalized Medicine Coalition, there are more than 50 genetic tests currently available that can inform treatment decisions and drug therapy for a wide range of diseases. With the availability of these tests, support and demand for personalized medicine is growing internationally. However, effective integration of personalized medicine into clinical care is challenging. It is widely thought that effective adoption of personalized medicine will require the participation of informed and engaged patients and healthcare providers.

Cepmed plans to use the Portal as a key element of implementation studies in personalized medicine, collaborating with healthcare providers, patient organizations and the public to define how personalized medicine is best applied within the Canadian health care system. These studies will be informed by Cepmed's participation in DNA Direct by Medco's GMN. The GMN brings together leaders in personalized medicine and offers opportunities to establish multi-site studies in genomics, with a particular focus on real-world or implementation studies.

"We are excited about this opportunity to expand our Genomic Medicine Network to include a premier personalized medicine organization in Canada," said Joan Kennedy, President of DNA Direct by Medco. "Cepmed will add a unique perspective and new types of collaboration opportunities across the network."

Source: Marketwire

OGT Signs Licensing Deal for Colorectal Cancer Biomarkers

Biomarker Commons Newsbot — Wed, 22 Feb 2012 21:42:00 +0000

Oxford Gene Technology (OGT), provider of innovative clinical genetics and diagnostic solutions to advance molecular medicine, announced today that it has entered into an exclusive licensing agreement with Inven2, the technology transfer office at Oslo University Hospital (OUS) and University of Oslo (UiO), for 12 highly promising colorectal cancer tissue biomarkers.

The exclusive license allows OGT to commercialise any resulting test developed using these biomarkers and to sublicense the markers to other parties. The DNA methylation biomarkers were developed in the laboratory of Professor Ragnhild A. Lothe, in the department of Cancer Prevention, the Norwegian Radium Hospital, part of the Oslo University Hospital.

OGT has validated the results obtained in Professor Lothe’s laboratory showing sensitivity of 93% and specificity of 90% when using tissue biopsies. Further work investigating the efficacy of these biomarkers in blood and faecal samples is ongoing.

“This licensing agreement gives OGT exclusive access to genetic markers which are associated with colorectal cancer.” stated Mike Evans, CEO, of OGT. “We believe that developing tests that include these genetic markers will permit the earlier identification of patients at risk of this disease and allow for more timely diagnosis and clinical interventions.” He added, “The higher specificity of this new panel of markers could provide a more robust screening tool than the tests currently used, while eventually lowering overall costs, which would be of significant benefit for both patients and the clinicians using them.”

“Biomarkers have the potential to greatly improve the accuracy and impact of colorectal cancer screening.” commented Professor Lothe, from the Norwegian Radium Hospital. “We look forward to continuing our collaborative efforts with OGT to develop and validate a future test which will help screen people early for this treatable form of cancer.”

Benedicte Bakke, Business Development Manager at Inven2 AS, Oslo technology transfer office, concluded: “We fully support the collaboration with Oxford Gene Technology to develop a new method of detecting colorectal cancer using these biomarkers. This deal demonstrates the importance of industry and academic collaboration in turning scientific excellence into products that address medical needs.”

Source: Oxford Gene Technology

Apceth and Indivumed to Develop Biomarker Platform for Targeted Cellular Therapies

Biomarker Commons Newsbot — Wed, 22 Feb 2012 20:46:38 +0000

apceth GmbH & Co. KG, located in Munich, Germany, and Indivumed GmbH, based in Hamburg, Germany, have entered into a partnership for the development of a predominantly tissue-based biomarker strategy for the treatment of solid cancers with cellular and/or gene therapeutics. The goal is to predict the response of a targeted cellular/gene therapy in different cancer types and to stratify patients to provide a more individualized cancer treatment with apceth's innovative cell and cell-based gene therapeutics. A reliable biomarker platform will enable oncologists to identify those patients who will most likely benefit from the treatment with apceth's therapeutics, thus establishing a unique and truly personalized therapeutic approach adapted to the needs of each cancer patient.

Since biomarkers for cell and gene therapeutics are not yet available and cancer is still a growing medical problem worldwide, significant demand for an adequate and reliable biomarker platform exists.

Indivumed has specialized in obtaining high-quality biospecimens and clinical data from surgical cancer patients and has established a unique tumor biobank and clinical research infrastructure. A special analytical platform for cancer tissue allows Indivumed to identify and validate protein biomarkers and targets with extremely high reliability in terms of their clinical application. One of Indivumed's strengths is analyzing cancer pathway molecules for predicting drug response. apceth wants to make use of Indivumed's highly regarded tumor tissue bank and its expertise in tissue-based biomarker discovery and validation. Both companies believe that the combination of apceth's therapeutic approach and Indivumed's biomarker platform has the potential to drive future cancer therapeutics and pharmaceutical innovation, thereby making the promises for personalized medicine a reality.

The current project is funded by the German Federal Ministry of Education and Research (BMBF) as part of the Munich Leading-Edge Cluster (project number:01EX1021K).

Both companies look forward to future collaborations for the development of reliable biomarker sets to predict the response of cell therapies in cancer .

Source: Indivumed

Dako Enters into an Additional CDx Collaboration with Amgen

Biomarker Commons Newsbot — Wed, 22 Feb 2012 14:45:55 +0000

Dako, a world leading independent cancer diagnostic supplier with 45 years of experience in pathology, announced today that it has entered into a new collaboration agreement with Amgen Inc. on the development of a diagnostic test for an Amgen cancer drug candidate in clinical development.

“It is Dako’s mission to fight cancer. Hence, we are pleased to be chosen as Amgen’s partner once again for the development of companion diagnostics linked to Amgen’s investigational targeted therapies,” says Lars Holmkvist, Dako’s chief executive officer.

Last month, Dako announced a collaboration agreement with Amgen Inc. introducing a new business model which supports the concurrent development of drug and diagnostics for a rare but deadly cancer – something that up to this point has been difficult to achieve in the industry.

“This new collaboration with Amgen underlines Dako’s commitment to advance personalized medicine in cancer treatment as the selection of patients most likely to benefit from a specific treatment will increase the probability of therapeutic success for cancer patients suffering," Lars Holmkvist adds.

Today’s news comes on the heels of several pharmDx collaborative agreements recently announced by Dako.

The demand for personalized medicine is increasing with the recognition that it may provide a way to improve patient care and manage healthcare costs by targeting treatments to individuals more likely to benefit from specific therapies.

Source: Dako

Fighting Breast Cancer: New EU-funded Biomarker Project Kicks Off

Biomarker Commons Newsbot — Tue, 21 Feb 2012 23:00:35 +0000

A new EU-funded biomarker project that aims to get breast cancer therapy more tailored to individual patients has just got under way. By ensuring that breast cancer therapy is specifically designed with an individual patient in mind, medical practitioners can bypass ineffective treatments - saving both valuable time and energy.

RESPONSIFY ('Genome-based biomarkers leading to validated molecular diagnostic tests for response prediction in breast cancer') received almost EUR 6 million under the 'Health' Theme of the EU's Seventh Framework Programme (FP7), and brings together researchers from Belgium, France, Germany, Sweden, Switzerland and the United Kingdom.

The project partners will work on developing new biomarker tests that can indicate whether and how a treatment affects an individual patient, and make response prediction much easier.

The main focus of the project will be on ascertaining whether certain types of treatment should be administered before or after surgery. Doctors often need to determine which therapy is best for a patient about to undergo surgical tumour removal; in most breast cancer cases it is only after the removal and examination of the tumour that doctors choose a therapy. However, just because this is the dominant form of treatment does not mean it is best for everyone. Treatment that starts prior to surgery, called 'neoadjuvant therapy', involves significantly minimising the tumour preoperatively. Only then do doctors remove the remaining tumour tissue.

Professor Carsten Denkert, from the coordinating institution Charité - Universitätsmedizin Berlin, comments: 'The advantage of neoadjuvant therapy is that the effective response of the therapy on the tumour is immediately visible. This is why we are better able to judge which biomarkers are appropriate for directing the therapy.'

The team will use different genome-based strategies to identify and characterise new biomarkers as well as validate biomarkers from previous projects. Genome-based strategies include new molecular techniques such as genome-wide next-generation sequencing, epigenetics, gene and exon expression analysis, as well as kinome arrays, in situ proteomics and quantitative polymerase chain reaction (qPCR) using formalin-fixed paraffin-embedded (FFPE) tissue.

By integrating information on response prediction from different breast cancer types and methodologies into biomarker tests for targeted therapies in the clinical routine setting, researchers can work towards meeting the challenges surrounding individualisation of cancer therapy based on standardised biomarker assays. To bring these tests to market, they will then be developed for commercialisation by the industry and small and medium-size enterprise (SME) partners in the consortium.

The results from the project will be presented on a web-based data integration and processing system. Standardising the integration of clinical trial data and biomarker results into one system allows easy access for further clinical biomarker driven trials.

The World Health Organization (WHO) reports that breast cancer is the most common cancer among women around the world, both in the developed and the developing world.

Source: CORDIS

HistoRx Earns Patent on Quantitative Immunoassay Optimization

Biomarker Commons Newsbot — Tue, 21 Feb 2012 22:46:11 +0000

HistoRx, the leader in quantitative immunohistochemistry (IHC), advances its proprietary position in measurement of biomarkers in tissue through today's issuance of US Patent 8,121,365 protecting the company's "Methods and systems for determining optimal dilution of a reagent." As the first in what HistoRx expects will be a series of broadening patents pertaining to its quantitative methodology, this patent protects the company's capabilities in optimizing antibody concentration for quantitative immunoassays, methods required to generate high-quality reproducible clinical diagnostic results that precisely relate to biomarker concentrations in tissue sections.

HistoRx is developing diagnostic assays that bring the technical precision of clinical pathology to the anatomic pathology setting: objective, quantitative and reproducible results for biomarkers in biopsy specimens should be available to all patients and clinicians as readily as accurate measurements of glucose in blood. In addition to the company's cutting-edge proprietary AQUA technology, HistoRx is uniquely addressing other aspects of the pre-analytic and analytic phases of biomarker assessment in anatomic pathology. While reagent performance is assessed subjectively in traditional IHC methodology, the techniques covered in this patent optimize the range of the assay analytically, which provides superior results regardless of analytical platform.

"Analytical precision is a prerequisite for clinical accuracy," said Mark Gustavson, Ph.D., Director of Operations at HistoRx and one of the inventors. "This patent is further recognition of HistoRx's leading approach to achieving objectivity and reproducibility in anatomic pathology."

AQUA technology is an automated, quantitative IHC testing method that enables measurement of protein biomarkers in tissue as an aid to a pathologist's diagnosis. AQUA analysis is used in cancer research by more than twenty leading academic centers worldwide, is part of the clinical development plans for oncology drug candidates from several major pharma companies, and has been cited in more than 120 peer-reviewed publications. In the clinical diagnostic setting Genoptix Medical Labs, a Novartis company, has commercialized diagnostic tests based on AQUA technology licensed from HistoRx. AQUA software is currently compatible with the ScanScopeFL from Aperio and the Vectra 2 system from Caliper Life Sciences.

Source: PR Newswire

Covance Scientists to Present at the Molecular Med Tri-Con

Walter Jessen — Mon, 20 Feb 2012 00:00:00 +0000

Scientists from Covance Discovery and Translational Services will be showcasing their company's R&D capabilities, talent and technologies in biomarkers, discovery services, genomics and proteomics to over 3,000 participants at the 2012 Molecular Med Tri-Con this week in San Francisco, CA.

The Molecular Med Tri-Con is a unique conference that brings together the therapeutic and diagnostic aspects of the life sciences industry in one place with access to over 3,000 delegates from 1,200 companies. Spanning five days (Sun 2/19 – Thurs 2/23), the event includes 12 core programs, 450+ presentations, 60+ posters and 140+ exhibitors.

Covance Discovery and Translational Services, which integrates the company's Antibody Products, Biomarker Center of Excellence, Discovery Services, Genomics Laboratory and Immunology Services, was created in 2010 to offer clients a depth and breadth of drug discovery and biomarker services unmatched in the CRO industry.

Scientists from the Biomarker Center of Excellence, Discovery Services, the Covance Genomics Laboratory and Antibody Products will be available at the conference to discuss the company's spectrum of services and expertise, including Covance's new BioPathways resource, which enables scientists to search biological and disease pathways and rapidly identify validated assays and commercially available antibodies.

Covance and Ingenuity to demo new tools in next gen sequencing

This year at the Molecular Med Tri-Con, Covance, which offers comprehensive and fully integrated genomics services to provide clients the highest quality data and ease of use from sample acquisition to actionable results, and Ingenuity Systems, a leading provider of information & analytics solutions for life science researchers, will demonstrate the latest tools in next-generation sequencing data analysis. Covance and Ingenuity will demonstrate Ingenuity Variant Analysis, a web application that helps researchers studying human disease to identify causal variants from human resequencing data in just minutes. Come learn how the Covance and Ingenuity partnership can provide you a combination of high quality genomics data and innovative tools for data interpretation.

Date: Tuesday, February 21st, 12:40 pm - 4:20 pm
Location: Moscone North Convention Center, Room 114

Covance and Affymetrix lunch seminar

Also on Tuesday, a Covance and Affymetrix lunch seminar will feature two speakers discussing the clinical applications of pharmacogenomics:

Mark Parrish, Senior Manager of Assay Development and the Covance Genomics Laboratory will discuss clinical applications of pharmacogenomics and present on high-throughput DMET profiling for drug development.
William Douglas Figg Sr., Pharm.D., M.B.A, Senior Scientist and Head of the Clinical Pharmacology Program and Molecular Pharmacology Section, Medical Oncology Branch and the Center for Cancer Research, National Cancer Institute and National Institutes of Health, will talk about moving pharmacogenetics from the laboratory to the clinic.

Date: Tuesday, February 21st, 12:40 pm - 1:40 pm
Location: Diagnostics Channel, Genomic Screening & Diagnosis of Human Diseases Track

Covance scientists to present four posters

This year, four scientists from Covance Discovery and Translational Services will be presenting posters, discussing data mining, biomarker discovery, whole exome sequencing, and miRNA extraction.

Mining PubMed for Biomarker-Disease Associations to Guide Discovery
Walter J. Jessen, Ph.D., Covance Biomarker Center of Excellence
Optimizing Therapeutic Outcomes for Glioblastoma Multiforme Leveraging Whole Exome Sequencing
Anup Madan, Ph.D., Covance Genomics Laboratory
Mapping the Molecular Genomic Network of Glioblastoma Multiforme
Anup Madan, Ph.D., Covance Genomics Laboratory
Optimization of miRNA Extraction from Serum
Zinaida Sergueeva, Ph.D., Covance Genomics Laboratory

Covance scientific experts available to discuss drug discovery and biomarker services

Attendees at the 2012 Molecular Med Tri-Con can also visit booth 206/208 in the Exhibit Hall and register to win an Apple iPad. Scientific experts in biomarkers, companion diagnostics, computational biology, discovery services, genomics, oncology studies and translational medicine will be available to discuss how Covance can help their clients make faster and more effective decisions about their portfolios.

Source: Covance Discovery and Translational Services

Ingenuity Variant Analysis Enables Rapid Identification of Causal Variants From Human Resequencing Studies

Biomarker Commons Newsbot — Sat, 18 Feb 2012 04:11:00 +0000

Ingenuity Systems, a leading provider of information and analysis solutions for life science researchers, today announced the general availability of Ingenuity Variant Analysis, a web application designed to help researchers studying human disease rapidly identify causal variants from human resequencing data. Researchers can quickly and reliably take a list of millions of variants down to the most compelling set of variants for follow-up study and analysis.

Ingenuity Variant Analysis supports individual whole genome or exome studies with thousands of samples without deleting data sets. Unlike other software products that focus only on called and annotated variants, Ingenuity Variant Analysis streamlines the annotation and prioritizing of all variants through rich biological interpretation and analysis. Its unique combination of filtering, analytics, and richly annotated content allows researchers to identify and prioritize variants by drilling down to a small, targeted subset of compelling variants based both upon published biological evidence and the researcher's own knowledge of disease biology.

"Several years ago I resigned myself to the challenge of identifying genetic variants in my daughter's DNA that might account for her decreased muscle and other findings that together constituted an undescribed syndrome. My own clinical experience and my recent work with MyDaughtersDNA.org has made plain the fact that there are many undiagnosed and even novel cases involving genetics that sets off similar quests for many other families and their physicians," said Dr. Hugh Young Rienhoff, a physician and Director of My Daughter's DNA. "To see this step forward, of making genome analysis a more manageable challenge for the majority of us who do not write code or have the services of a bioinformatician, is heartening. Ingenuity Variant Analysis allows the user to browse sequence data in an intuitive manner both posing hypotheses and generating them. This is an important advance allowing a far greater number of users to together unlock the full potential of Next Generation Sequencing."

"Ingenuity Variant Analysis provides a fast, interactive experience for biological interpretation of variants from resequencing studies that's really fun to use," commented Anup Madden, Ph.D., Genomics/Sequencing Team Leader, Covance Genomics Laboratory. "Without training, we were able to sit down with this software and in less than 2 hours we identified variants that stratified a population of drug responders from non-responders that have really compelling biological support based on the drug's mechanism of action. We can interactively ask biological questions and get real-time insights to prioritize variants using Ingenuity's Knowledge Base of curated up-to-date pathways, processes, models, variant, drug and disease findings from the literature."

"We focused on creating a solution that enables researchers to reliably identify and prioritize the most biologically relevant variants from DNA resequencing studies," said Doug Bassett, Ph.D., Chief Scientific Officer and Chief Technology Officer, Ingenuity Systems. "Using Ingenuity Variant Analysis, researchers can leverage the combination of analytics and rich content to identify causal variants for a rare disease, identify driver variants for a particular cancer of interest, or identify candidate DNA biomarkers – all within minutes."

Source: PR Newswire

SOMAscan Technology Presented at 2012 AAAS Meeting

Biomarker Commons Newsbot — Sat, 18 Feb 2012 04:03:32 +0000

“Prediction” is only part of what is needed to realize the promise of personalized medicine: It is perhaps more critical to detect the early onset of disease in real time, when it is most likely to be successfully treated. Dr. Larry Gold, CEO of SomaLogic and Professor at the University of Colorado Boulder, presented a breakthrough technology that promises to provide such sensitive and early detection, and ultimately transform the practice of medicine. His talk, Unlocking Biomarker Discovery, was given at a special Session on “Predictive Medicine” on February 17, 2012, at the American Association for the Advancement of Science (AAAS) annual meeting in Vancouver, Canada.

Genes are uniquely “predictive.” Indeed, the recent, astounding advances in genomics provide an ever-finer risk assessment for a variety of diseases. But although one’s genetic makeup may predict the lifetime risk of a particular disease, it rarely informs a particular individual whether or not he or she has actually contracted that disease. Truly personalized medicine requires more immediate and more accurate molecular markers of health and disease. And those markers are most likely to be found among the 20,000-plus proteins that circulate through the body at varying concentrations, concentrations that are related directly to the state of wellness of the body from which they arise.

Proteins, however, are notoriously difficult to measure accurately, sensitively, and in a high-throughput manner. First-generation proteomic technologies like chromatography, 2D gels, mass spectrometry and antibody-based ELISAs each have advantages, but none can capture a complete picture of the human proteome rapidly and cost-effectively. SomaLogic’s new SOMAscan™ technology, based on novel SOMAmer™ protein capture reagents, can identify and measure thousands of proteins from a drop of blood or other biological sample. The SOMAscan assay finally unlocks protein biomarker discovery to drive new therapeutic and diagnostic discovery and development.

In his talk, Dr. Gold provided examples of how the SOMAscan assay has already been applied successfully to clinical and companion diagnostics, new drug discovery and development, and new understandings of normal biology and disease. He also introduced the idea of the “Wellness Chip,” a single assay tool that could empower each person to maintain his or her own state of health, and usher in a new age of truly “personalized” medicine.

Source: SomaLogic

FirstMark's Landmark Clinical Study Successfully Completed that Fulfills the Unmet Need to Access the Risk of Near Term MI

Biomarker Commons Newsbot — Sat, 18 Feb 2012 03:50:50 +0000

FirstMark today announced the completion of the clinical study for the multiple biomarker cardiovascular blood test PREvent. These clinical results demonstrate the extraordinary effectiveness of the test to predict near term (2-3 years) risk of myocardial infarction and death in patients with suspected or confirmed, insignificant or significant CAD. The clinical study and final data was well received in an oral presentation, An Aggregate of 3 Biomarkers Predict Very High Risk of Acute Myocardial Infarction and Death, by Dr. Stephen E. Epstein, Executive Director of the Cardiovascular Research Institute, MedStar Health Research Institute, at the Cardiovascular Research Technologies 2012 Conference in Washington D.C. on February 6, 2012.

The study revealed superior cardiac risk information by identifying the top 5% of CAD at the highest risk of MI with a hazard ratio of 5.5. The data showed an annual average of 18.2% of significant CAD patients with all three biomarkers elevated experienced a myocardial infarction or death, compared to only 2.45% of significant CAD patients with all biomarkers normal. The multiple biomarker model adds markedly to traditional risk-prediction by significantly improving C-statistics from 0.695 for base model to 0.750, distinguishing high risk from low risk subjects.

"We are very pleased about the outstanding data results, and the promise PREvent brings to cardiovascular medicine," said Thomas Silberg, President and CEO of GenWay Biotech. "It's important for physicians to have a simple method to detect patients at greatest risk of near term MI. Ideally this information will lead to the most aggressive therapy, compliance and management in hope to eliminate MI and reduce death."

About the Study

The study was based on long-term research that reveals that there are multiple factors involving components of inflammatory, thrombotic, infectious, and autoimmune pathways that contribute to the development of CAD, subsequent plaque rupture, and adverse outcomes. The research interrogated these pathways both separately and combined, utilizing HSP70, HSP60, hsCRP, FDP levels and seropositivity to CMV biomarkers. The biomarker panel was narrowed down to three markers that provide most valuable information to include hsCRP, FDP, and HSP70. A bioanalytic statistical ranking model (the Aggregate Pathway Risk) was developed that best predicts existing CAD as well as imminent MI.

The controlled study included blood samples from 3,800 patients admitted for cardiac catheterization. The individuals were documented from angiograms for the presence and severity of coronary artery disease. The study design included four groups of patients angiographically confirmed with insignificant or significant CAD, with MI or death and without MI or death. Each group was followed for a minimum of 1 year and a mean of 2.75 years. Groups were matched for age, gender, and cardiovascular risk factors using propensity scoring.

Source: PR Newswire