Biomarker Commons

GeneNews' First U.S. Marketing Partner Launches ColonSentry

Biomarker Commons Newsbot — Tue, 10 Apr 2012 19:43:57 +0000

GeneNews Limited (TSX: GEN), a company focused on developing and commercializing blood-based biomarker tests for the early detection of diseases and personalized health management, announced that Enzo Clinical Labs, a division of Enzo Biochem, Inc. (NYSE:ENZ), has launched ColonSentry®, the world's first blood test to assess an individual's current risk for colorectal cancer.

"Colonoscopy is widely regarded as the gold standard for colorectal cancer detection. As a risk stratification test, ColonSentry® may facilitate a decision to undergo colonoscopy for those who would otherwise refuse the procedure. It can also help prioritize patients at greater current risk for colorectal cancer in healthcare systems with limited colonoscopy capacity. Widespread adoption of the test could lead to earlier detection of colorectal cancer, improved patient outcomes and reduced healthcare costs," commented Gailina J. Liew, President and Chief Operating Officer of GeneNews.

Ms. Liew continued, "Enzo's launch of ColonSentry is a significant milestone for the commercialization of GeneNews' proprietary Sentinel Principle® platform technology. It also provides us with access to a key market for molecular diagnostic tests and an important first entry point into the U.S. market."

Source: GeneNews

Metabolon Launches Strategic Outsourcing Programs Focused on Disease Metabolism

Biomarker Commons Newsbot — Tue, 10 Apr 2012 19:36:43 +0000

Metabolon, Inc., a diagnostics and services company offering the industry’s leading biochemical profiling technology, announces the launch of its Disease Metabolism Strategic Outsourcing Program.

Through this program, Metabolon’s partners will collaborate toward shared objectives such as identifying novel targets, establishing high resolution phenotypic screening platforms, elucidating drug mechanism of action, discovering and validating pharmacodynamic biomarkers for translation to the clinic and for patient stratification. Partners will have access to dedicated scientific, technical and IT staff at Metabolon, along with the company’s proprietary disease ontologies, as well as supporting visualization tools for the integration of metabolomics data with existing or data derived from such disciplines as genomics and proteomics.

John Ryals, Metabolon President and CEO, said, “We are excited to launch our Strategic Outsourcing Program as it represents a step change in the way the industry will think about and use metabolomics. This initiative results from years of research and development at Metabolon and has been requested by our industrial clients to fully exploit the potential of our platform. We believe that integrating metabolomic profiling deeply at the various stages of the R&D trajectory will lead to better targets, higher quality molecules, faster time to the clinic and reduced R&D risk and cost.”

Metabolon has completed hundreds of projects including those in oncology and metabolic disorders, and has acquired vast institutional knowledge of the metabolic pathways and targets that are involved in the onset of disease and its progression. This new program offers a turnkey metabolism center of excellence that provides pharmaceutical and biotech partners access to the most advanced metabolomics research platforms, which serve to enhance their drug discovery and development efficiency. Metabolon’s platform yields actionable insight into key disease metabolic processes, drug action, and patient response.

Source: Metabolon

GeneTex Launches Monoclonal Antibody to Detect CA IX Cancer Biomarker

Biomarker Commons Newsbot — Tue, 10 Apr 2012 19:30:33 +0000

GeneTex, a leading manufacturer of antibodies, is pleased to announce that they will be launching a new antibody against CAIX, a marker of hypoxia that shows great promise for cancer research.

Hypoxia in tumors is closely associated with tumor aggressiveness and resistance to radio- and chemotherapeutic treatment. Therefore, reliable markers for hypoxia represent both valuable diagnostic markers and potential targets for therapeutic intervention.

Carbonic anhydrase IX, or CAIX, is a transmembrane protein whose expression is restricted to very few normal tissues, in particular the membranes of gastric mucosal epithelial cells. Under hypoxic conditions, hypoxia inducible factor-1 alpha (HIF-1a) is stabilized and the transcription factor HIF-1 transactivates the CA9 gene, resulting in expression of the CAIX protein in the hypoxic cells. CAIX is involved in both the extracellular acidification of hypoxic tumors, as well as the regulation of intracellular pH, making it an attractive target for therapies based on the manipulation of pH (Parks, et al., 2010).

CAIX is considered to be one of the best cellular biomarkers of hypoxia. Furthermore, recent studies examining the association between CAIX levels and various clinicopathological outcomes suggest that CAIX expression may also be a valuable prognostic indicator for overall survival (Kirkpatrick et al., 2008; Jubb et al., 2009).

GeneTex is proud to introduce a superior monoclonal antibody against CAIX that has been fully validated through immunohistochemistry, immunofluorescence, western blotting and FACS.

Source: PR Newswire

Ezose Sciences and Sigma-Tau Advance Projects in Glycomics

Biomarker Commons Newsbot — Tue, 10 Apr 2012 19:24:35 +0000

Ezose Sciences Inc. announced today a further agreement whereby Ezose’s glycomics capabilities will be applied to biologics research and development projects at SIGMA-TAU Industrie Farmaceutiche Riunite S.p.A

This new collaboration will build on R&D work conducted under prior agreements between Ezose and SIGMA-TAU. Financial terms and other details were not disclosed.

“We look forward to building on our past accomplishments and progressing our work with SIGMA-TAU scientists,” said Kiyoshi Nagata, Ph.D., Chairman and Chief Executive Officer of Ezose. “We are committed to enabling glycomics as a research tool of growing importance for our corporate partners.”

Marco Brughera, Corporate R&D Managing Director of SIGMA-TAU, said, “As a company committed to innovation, we rely not only on the contributions of SIGMA-TAU’s in-house scientific talent but also on the support of others who are pioneering their special fields. We welcome this opportunity to work with Ezose in bringing their unique glycomics capabilities to our research program.”

SIGMA-TAU, founded in Italy in 1957 and based in Pomezia (Rome, Italy), is a leading, all-Italian capital, international pharmaceutical group that invests in the research, development, and marketing of innovative and effective treatments to improve human well-being and quality of life, focusing in particular on immuno-oncology and biotechnology and on rare, neglected, and/or high social impact diseases.

Source: Ezose

Leica Microsystems Introduces Tissue IA 2.0* Quantitative Image Analysis

Biomarker Commons Newsbot — Tue, 10 Apr 2012 15:18:43 +0000

Leica Microsystems recently announced the release of Tissue IA 2.0, high performance image analysis for discovery research. Combining fluorescence and brightfield analysis capabilities in a single platform, with precision cell modelling, Tissue IA 2.0 offers a superior solution for IHC biomarker quantification. Tissue IA 2.0 joins the Total Digital Pathology portfolio from Leica, providing streamlined end-to-end excellence in capture, management and analysis of digital pathology images.

A major challenge in research today is retrieval of quantitative, reproducible data from tissue-based IHC studies. Tissue IA 2.0 provides expert tools for researchers to extract the most from their studies. Powerful color separation and multi-marker colocalization functionality provides advanced insight and unbiased measurement of multiple antigen immunostaining in brightfield or fluorescent samples. Sophisticated cell modelling accurately detects and quantifies differential expression of staining in cellular compartments, providing detailed insight into cytoplasmic, membrane and nuclear biomarker localization.

The advanced dual staining capabilities in Tissue IA2.0 enable researchers to identify cell cohorts at the molecular level. Use one marker to identify a population of interest and then quantify expression of a second, providing exceptional analysis performance and greater understanding of your slides. Algorithms are easily adjusted and optimized for different markers, tissue and protocols giving a flexible platform for drug discovery applications.

Easy to deploy and easy to use, the Tissue IA web-accessible interface means that users can take their analysis with them wherever they go. With high throughput batch analysis capacity, Tissue IA 2.0 will process whole slides, regions of interest or tissue microarray cores, and automatically integrate analysis results with your slides. A built-in upload interface facilitating integration of algorithms from 3rd party software solutions, gives greater flexibility to further expand your analysis options.

Dr. Donal O’Shea, Head of Digital Pathology in Leica Microsystems, says: “Mulitplexing is of growing importance in translational research and tools to help quantify the expression and location of multiple biomarkers concurrently in tissue are a real requirement. TissueIA 2.0 delivers for the user through offering chromogenic and fluorescence quantification and co-localization, cell based histoscoring on multi-compartmental IHC staining and the power to include and exclude cell populations based on biomarker expression. In conjunction with our SCN400 F and Ariol platforms, this further expands our Digital Pathology portfolio for the life science and clinical researcher and demonstrates our ongoing commitment to this area.”

Tissue IA 2.0, with its powerful, streamlined analysis, is the ideal choice for biomarker discovery and translational research. Its unique combination of flexibility, automation and ease-of-use make it an unparalleled tool for digital pathology research.

Source: Leica Microsystems

Translational Research Institute Seeks Individualized Approaches to Curing Global Epidemic of Diabetes

Biomarker Commons Newsbot — Tue, 10 Apr 2012 14:01:14 +0000

Orlando will soon be recognized as a medical destination seeking cures for diabetes, according to Florida Hospital - Sanford-Burnham researchers.

"It is my professional goal to cure diabetes," said Dr. Steven R. Smith, a diabetes expert and scientific director of the Florida Hospital - Sanford-Burnham Translational Research Institute for Metabolism and Diabetes (TRI). Researchers at the TRI, an innovative partnership between Florida Hospital and Sanford-Burnham Medical Research Institute, believe that by applying the concept of personalized medicine to diabetes and obesity, the TRI can help "crack the code" on these global epidemics and provide a more individualized, tailored approach to finding cures.

Diabetes and metabolism-related diseases now affect nearly one out of every three Americans. However, the current model for treating both diabetes and obesity reflects a one-size-fits-all model of "eat less and exercise more." Alexandra Fields-Garrity, a 27-year-old psychology student, is a twin but the few differences that exist between her and her sister have had big consequences on Fields-Garrity's health.

"I have battled with weight issues my entire life and am now pre-diabetic," Fields-Garrity said. "My twin sister is the complete opposite of me in terms of weight and health issues, yet we share a very close genetic make-up. I enrolled in a research trial at the TRI so my information can help the researchers understand what makes my sister and me so different."

Fields-Garrity's story is just one example of what the research at the TRI will help to uncover.

"One of the key goals of the research being conducted at the TRI is to broaden the basic understanding of the complex genetic and molecular causes of obesity, diabetes and associated cardiovascular complications," said Dr. Smith. "By working with innovative industry leaders and our basic science partners at Sanford-Burnham Institute, we hope to usher in a new era of personalized approaches preventing, diagnosing and treating these diseases because we know it is people like Alex who will benefit from our discoveries."

The TRI's new 54,000 sq. ft. facility in Orlando, Fla., contains a variety of tools that are crucial to finding cures including a research clinic, advanced imaging technology, a biorepository for sample collection and storage, as well as several other resources for metabolic studies. One of the facility's highlights is the Calorimetry Laboratory, which contains two "dorm" sized rooms and two small calorimeter rooms that will analyze the air in the room to measure energy expenditure and the type of food a person is burning without the person having the discomfort of being hooked up to machinery. The two small calorimeter rooms will be the first ever designed for precisely measuring energy expenditure at rest or during exercise.

"Our partnership with Florida Hospital exemplifies a new, translational research model that will speed the development of personalized therapies," said Dr. John Reed, CEO of Sanford-Burnham Medical Research Institute. "The application of our advanced research technologies to clinical studies at the TRI has the potential to revolutionize health care through the discovery of molecular signatures of disease."

The TRI bridges the fundamental discovery research conducted in Sanford-Burnham laboratories with clinical studies at the new TRI facility, providing a bench-to-bedside research continuum. The research will be empowered by genomics and metabolomics technology platforms at Sanford-Burnham and sophisticated resources at the TRI. The two-way information sharing is expected to accelerate discoveries and pave the way towards a personalized approach to treating metabolic diseases.

In fact, the first research advancing from Sanford-Burnham to the clinical research stage at the TRI will begin this spring. The research will focus on orexin, an appetite-inducing hormone produced in the brain, which appears to resolve obesity without changes in food consumption or elevation in physical activity.

"Advancing this study to the TRI is a crucial first step in translating fundamental research at Sanford-Burnham to the clinical phase," said Dr. Smith. "The infrastructure in the new TRI facility has a variety of assets that are essential to this type of bench-to-bedside research."

Every year, diabetes and metabolic diseases cost Central Floridians more than $4 billon and nationally generate approximately $174 billion in direct and indirect costs, according to the American Diabetes Association. By linking the largest healthcare provider in Central Florida with a nationally renowned research institute, the TRI seeks to bridge the gap between the research bench and the patient's bedside to help find cures faster.

"The TRI's focus is a natural extension of Florida Hospital's overall focus on holistic, healthy living combined with world-class patient care," said Lars Houmann, president and CEO of Florida Hospital. "The new TRI facility represents another step forward in Orlando becoming a major medical destination and marks a major initiative in patient oriented research. The type of research that will be done at the TRI will change how physicians treat diabetes and obesity by creating more personalized therapies. This is a really exciting approach."

Source: Florida Hospital

Biomarkers for Autism Discovered

Biomarker Commons Newsbot — Tue, 10 Apr 2012 13:43:31 +0000

An important step towards developing a rapid, inexpensive diagnostic method for autism has been take by Uppsala University, among other universities. Through advanced mass spectrometry the researchers managed to capture promising biomarkers from a tiny blood sample. The study has just been published in the prestigious journal Nature Translational Psychiatry.

There are no acknowledged biomarkers for autism today. Researchers at Berzelii Centre and the Science for Life Laboratory in Uppsala who, in collaboration with colleagues at Linnaeus University in Sweden and the Faculty of Medicine in Tehran, Iran, who have discovered some promising biomarkers.

Many diseases are caused by protein alterations inside and outside the body’s cells. By studying protein patterns in tissue and body fluids, these alterations can be mapped to provide important information about underlying causes of disease. Sometimes protein patterns can also be used as biomarkers to enable diagnosis or as a prognosticating tool to monitor the development of a disease. In the current study disruptions of the nervous system were in focus when the scientists studied protein patterns in autism spectrum disorder (ASD).

To identify potential biomarkers (peptides or proteins), the researchers performed a detailed protein analysis of blood plasma from children with ASD compared with a control group. Using advanced mass spectrometric methods, they succeeded in identifying peptides consisting of fragments of a protein whose natural function is in the immune system, the complement factor C3 protein.

The study is based on blood samples from a relatively limited group of children, but the results indicate the potential of our methodological strategy. There is already a known connection between this protein and ASD, which further reinforces the findings, says Jonas Bergquist, professor of analytical chemistry and neurochemistry at the Department of Chemistry – BMC (Biomedical Centre) in Uppsala.

The hope is that this new set of biomarkers ultimately will lead to a reliable blood-based diagnostic tool.

The study was funded by the Swedish Research Council, among other financiers.

Study: A novel blood-based biomarker for detection of autism spectrum disorders

Source: Uppsala Universitet

Metabolon Awarded Analytical Methods Patent

Biomarker Commons Newsbot — Mon, 09 Apr 2012 21:32:57 +0000

Metabolon, Inc., a diagnostics and services company offering the industry’s leading biochemical profiling technology, recently announced the grant of US Patent 8,131,473 "Data Analysis Methods for Locating Entities of Interest within Large Multivariable Datasets." The patent was issued on March 6, 2012 and is the sixth technology patent and nineteenth patent overall awarded to Metabolon. The invention describes analysis methods and computational tools developed by Metabolon to quickly and accurately locate biochemicals, genes and proteins of interest in large multivariate data.

The use of genomics, proteomics and metabolomics to answer a variety of biological questions has increased dramatically over the last few years. These ‘omics sciences generate massive amounts of data, and sifting through that data to identify biologically significant changes is a major rate-limiting step. The patented method enables the researcher to process, analyze, and interpret data more efficiently. Through the implementation of these techniques, the relevant changes in transcripts, proteins and biochemicals in an experimental sample can be quickly and accurately identified. This enables the interpretation of the results, and facilitates the understanding of biological mechanisms and modes of action.

Source: Metabolon

Major Lung Cancer Screening Trial announced by the NHS in Scotland using an innovative blood test, EarlyCDT–Lung

Biomarker Commons Newsbot — Mon, 09 Apr 2012 21:20:38 +0000

Sir Harry Burns, The Chief Medical Officer for Scotland recently announced that Scotland will conduct a major screening trial for lung cancer using EarlyCDT–Lung – a simple blood test that detects cancer at its earliest stages of development. EarlyCDT–Lung has been available in the US for more than two years and has been shown to detect early and late stage cancers in research studies as well as in clinical use. An audit of more than 1,500 patients has been overseen by independent leading cancer clinicians and confirms the test performs in the clinic as expected. The objective of this randomised prospective trial is to ascertain the cost–effectiveness of EarlyCDT-Lung in screening high risk patients. Initial calculations from an independent firm of health economists in Boston show that it should be highly cost effective and reduce lung cancer mortality. Lung cancer survival rates in the UK have remained very poor (9% five year survival) for decades.

The trial will include 10,000 high-risk smokers (defined as having smoked the equivalent of 20 cigarettes per day for over 20 years). Half of the identified population will have EarlyCDT-Lung; those who are positive will be followed up with low dose computed tomography (CT) scans in order to identify if lung cancer is present. The other half will not be screened with EarlyCDT-Lung but will have the current standard of care. The clinical outcomes and the overall cost of care including using the EarlyCDT–Lung test, will be compared with the clinical outcomes and the overall cost of care of the non-screened group.

Why Conduct this Trial Now?

The outlook for lung cancer has for the first time been shown to benefit from a screening programme with CT. In the US, the National Lung Screening Trial (NLST) (1) on over 53,000 high risk smokers showed a 20% mortality benefit for screening with CT compared to chest X-ray. However, CT screening is expensive and initial calculations from the trial show it is unlikely to achieve a cost effective position to justify national screening. The UK has an additional issue to contend with as there are insufficient CT machines to support a national screening programme. It is therefore very important to find a test that is a pre-screen for CT that reduces the overall cost to an acceptable level and thus will allow the mortality benefit of screening with CT to become a practical reality. EarlyCDT–Lung will detect approximately half the cancers in the screened population and reduce the overall number to be followed up with CT to 7%. Having up to half the cancers in only 7% of the screened population should make the combination of EarlyCDT–Lung followed by CT highly cost effective. Initial calculations show that it may even reduce the overall cost of care for this high risk population whilst at the same time saving a significant number of lives.

Sir Harry Burns (The Chief Medical Officer for Scotland) stated:

The earlier a cancer is diagnosed the greater the chance it can be treated successfully, and currently 85 per cent of patients with lung cancer remain undiagnosed until the disease has reached an advanced stage. This pilot project is part of our Detect Cancer Early programme, which aims to increase the early detection of cancer by 25 per cent. By testing those at greatest risk of developing lung cancer, and diagnosing it at its earliest possible stage, we stand a better chance of being able to treat the cancer successfully. This means patients can be treated when their general health is better and when less aggressive treatment may be required than if the cancer had spread.

Professor John Robertson ([Director of CEAC, and Founder and Chief Scientific Officer of Oncimmune Ltd) said:

After many years of developing and refining this autoantibody test I am very proud of what we have achieved. The test is highly reproducible and will I believe lead to significant improvement in prognosis for a substantial number of lung cancer sufferers. The significant amount of performance validation work that we carried out before the test was launched in the US has led to the test performing commercially as expected. A randomised screening trial of this nature will help validate its use as a screening tool. We are working hard on bringing the next test for the early detection of breast cancer to the market within a year. We are also working on a number of similar tests for prostate, colon and ovarian cancer – a blood test to aid detection of all tumour cancers (70% of all cancer) is still the overriding objective of our work.

Geoffrey Hamilton-Fairley (Exec Chairman of Oncimmune Ltd) commented:

It is very good news that a simple blood test with the potential to improve prognosis for lung cancer sufferers is now available. It is important that since the performance of the test has been proven clinically, we establish the test’s cost effectiveness which will enable broad adoption of EarlyCDT-Lung so that the benefits of early detection can become a reality. The foresight of Scotland’s health team in identifying the clinical and economic benefits of a pre-screening test such as EarlyCDT-Lung and the speed with which they have put this trial in place is to be applauded.

Source: EarlyCDT–Lung

DoD Announces Prostate Cancer Biomarker Development Award

Walter Jessen — Mon, 09 Apr 2012 21:10:08 +0000

Last month, the Department of Defense (DoD) announced a Prostate Cancer Research Program (PCRP) Biomarker Development Award. The award supports high-impact research aimed at qualifying or validating biomarkers for rapid transfer to clinical practice for prostate cancer. The maximum award period is 3 years with a maximum allowable direct costs of $2.25 million. Projects studying multiple biomarkers are highly encouraged and multi-institutional efforts are highly encouraged. Presentation of preliminary data demonstrating the suitability of the biomarker(s) for further testing toward clinical application is required. Investigators must demonstrate availability and accessibility of samples and /or data, and are encouraged to leverage pre-existing resources such as biospecimen banks. Each PCRP funding opportunity either requires or encourages applications to address one of the following overarching challenges:

Develop effective treatments for advanced prostate cancer (i.e., disease progression with no available curative therapy)
Distinguish aggressive from indolent disease

All applications for FY12 PCRP funding opportunities must also address at least one of the following PCRP focus areas:

Biomarker Development: Qualification or validation of biomarkers for detection of aggressive disease, prediction and assessment of response to therapies, and prognosis and progression. These include validation studies of circulating tumor cells. Biomarker studies may include discovery if accompanied by qualification or validation.
Genetics: Understanding host or tumor genetics and epigenetics responsible for susceptibility, disease progression, and treatment outcomes for aggressive prostate cancer.
Imaging: Development of new anatomic, functional, and molecular imaging approaches for the detection and management of aggressive prostate cancer.
Mechanisms of Resistance: Understanding primary and acquired resistance to therapy.
Survivorship and Palliative Care: Improving the quality of life and well-being of prostate cancer patients and their families.
Therapy: Identification of new targets, pathways, and therapeutic modalities.
Tumor and Microenvironment Biology: Understanding prognosis and progression of prostate cancer.

FOA: W81XWH-12-PCRP-BDA : DoD Prostate Cancer Biomarker Development Award

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Biomarker Commons

GeneNews' First U.S. Marketing Partner Launches ColonSentry

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