Biomarker Commons: News

NYAS Symposium Review: Biomarkers and Brain Imaging of Presymptomatic Alzheimer's Disease

Walter Jessen — Wed, 01 Feb 2012 07:35:10 PST

The New York Academy of Sciences (NYAS) symposium, Biomarkers and Brain Imaging of Presymptomatic Alzheimer's Disease, was held last week Tuesday. About 150 people were in attendance consisting of a mix of academic and industrial researchers. [On a side note, the NYAS symposium office is located on the 40th floor of 7 World Trade Center and the views of New York city are spectacular.]

The biomarker symposium featured five speakers:

Reisa Sperling, MD, Brigham and Women's Hospital and Harvard Medical School
John C. Morris, MD, Washington University School of Medicine
Brian T. Gold, PhD, University of Kentucky
John Olichney, MD, University of California, Davis
Simon Lovestone, PhD, MRCPsych, MRC Centre for Neurodegeneration Research, London

Here are some of the comments and ideas captured from symposium.

First, Jennifer Henry, PhD, NYAS Director, Life Sciences, spoke. She welcomed everyone and talked briefly about NYAS. Robert B. Nelson, PhD, Lundbeck Research, then gave an introduction. The focus of the symposium "Exploring the Silent Years," he said, was to discuss an integrated view of structural, biochemical & functional events that precede Alzheimer's Disease. Two other comments caught my attention as he was speaking:

Neuritic plaques are no longer considered a tombstone marker but a trail marker on the path to Alzheimer's disease (appears prior to cognitive dysfunction)
Clusterin is a complement lysis inhibitor whose presence correlates with immune response to AD in blood.

The first speaker of the afternoon was Reisa Sperling, MD, from Brigham and Woman's Hospital and Harvard. Dr. Sperling is a neurologist specializing in dementia and imaging research, and an Associate Professor in Neurology at Harvard Medical School. Dr. Sperling is the Director of the Center for Alzheimer Research and Treatment at Brigham and Woman's Hospital and serves as the Director of the Alzheimer's disease Neuroimaging Program of the Massachusetts Alzheimer's Disease Research Center at Massachusetts General Hospital. Dr. Sperling's research is focused on the early diagnosis and treatment of Alzheimer's disease. Her recent work involves the use of functional MRI and PET amyloid imaging to study alterations in brain function during in aging and early Alzheimer's disease. The title of Dr. Sperling's presentation was Molecular and Functional Imaging of Preclinical Alzheimer's Disease: Defining Cohorts for Secondary Prevention Trials.

Over the course of AD, there is progressive failure of memory network function.
There's a relationship between the rate of amyloid-beta deposition and rate of cognitive decline.
Imagine if, like cholesterol with drugs that reduced heart disease by 25%, we could lower AD same way with anti-Amyloid treatment.

The next speaker was John C. Morris, MD, from Washington University School of Medicine. Dr. Morris is the Harvey A. and Dorismae Hacker Friedman Distinguished Professor of Neurology, Professor of Pathology and Immunology, Professor of Physical Therapy, and Professor of Occupational Therapy at Washington University. He also is the Director and Principal Investigator of the Alzheimer's Disease Research Center. The focus of Dr. Morris' research and practice is Alzheimer's disease and other neurological disorders associated with aging. Specific research interests include detecting preclinical Alzheimer's disease, improving the diagnosis of early-stage Alzheimer's disease, evaluating new drugs for the treatment of dementia, and establishing phenotypes for inherited forms of Alzheimer's disease and other dementias. The title of Dr. Morris' presentation was New Perspectives on 'Silent' Brain Amyloidosis: Relationships to Other Markers of Preclinical AD and Risk for AD Dementia.

Dr. Morris defines AD as, regardless of clinical status, a continuous process of synaptic & neuronal deterioration.
Many patients at the time of AD diagnosis have lost a great number of brain cells (some as much as 60%!)
We can enhance confidence that basis of dementia syndrome is AD using biomarkers.
AD biomarker tests must be standardized and validated; we have to classify sensitivity/specificity.
Dr. Morris showed data that a single AD marker in CSF isn't very specific, as it is also in other neurodegenerative diseases such as FTLD.
Clinical Amyloid imaging is coming (PIB, Florbetapir).
Question: what do we do when a cognitively normal person scores positive for AD PIB imaging?
Dr. Morris then talked about the aims of DIAN, Dominantly Inherited Alzheimer Network.

The third speaker of the afternoon was Brian T. Gold, PhD, an Associate Professor in the Department of Anatomy and Neurobiology at the University of Kentucky (UK) College of Medicine. Dr. Gold is the Director of the Cognitive Neuroscience Laboratory at UK. His research focuses on characterizing cognitive and brain changes associated with normal aging, early Alzheimer's disease (AD), and preclinical AD. In addition, Dr. Gold is investigating how certain lifestyle variables (e.g. exercise, education) may slow cognitive decline and brain aging. A multimodal imaging approach is employed, making use of functional magnetic resonance imaging and structural imaging methods such as volumetric assessment and diffusion tensor imaging. The title of Dr. Gold's presentation was White matter microstructural Alterations: Relation to Other Markers of Preclinical Alzheimer's Disease.

The average lifespan following diagnosis of AD is 8 years. We need better biomarkers.
Mild AD is too late for intervention therapies.
Dr. Gold showed pictures on diffusion tensor imaging (DTI). Different diffusion patterns indicative of different types of damage in the brain.
Dr. Gold uses DTI to study connections between different areas of the brain, correlate with clinical data.
Dr. Gold's presentation is complex; lots of acronyms, a number of regional brain areas. In summary, the data shows changes in connections with amnestic mild cognitive impairment (aMCI).
Gold's data shows different changes between various regions of the brain at different times during AD progression. Data dense presentation.

The next speaker was John Olichney, MD, a Professor of Neurology at University of California, Davis and Clinical Core Leader for their NIA-funded Alzheimer's Disease Center. He is responsible for overseeing a large multi-disciplinary clinical research program in dementia, including their Alzheimer's disease clinical trials unit. Dr. Olichney also directs the Cognitive Electrophysiology and Neuroimaging (CEaN) Laboratory in the Center for Mind and Brain at Davis, where he is active in translational cognitive neuroscience research. His main research focus is on the physiology of human memory function during normal aging and disease, using the techniques of event-related potentials (ERPs) and functional MRI (fMRI). The title of Dr. Olichney's presentation was Cognitive ERPs as Biomarkers for Very Early Alzheimer's Disease.

First, Dr. Olichney described ERP components, including P600 and N400, and how they can be elicited.
Dr. Olichney then showed event-related functional MRI data. He talked about an N600 or P400 repetition effect in mild AD.
Generally speaking, loss of both P600 and N400 supports loss of neural plasticity in AD.
Cognitive ERPs can provide useful biomarkers for staging AD.
Dr. Olichney thinks the measure of cognitive function may be more important for AD than Amyloid burden.

The last speaker of the day was Simon Lovestone PhD, MRCPsych, from MRC Centre for Neurodegeneration Research, London. Dr. Lovestone is Director of Research, King's Health Partners, Professor of Old Age Psychiatry at the Institute of Psychiatry, King's College London, and director of the NIHR Biomedical Research Centre for Mental Health and Unit for Dementia at the South London and Maudsley NHS Foundation Trust and King's College London. The title of Dr. Lovestone's presentation was Plasma and CSF-based Biomarkers for MCI and AD: Relationship to Pathogenesis, Conversion, and Progression Rate.

Problems in the AD biomarker pipeline include toxicity, efficacy, difficulty monitoring & predicting progression.
The problem with CSF biomarkers is that they fluctuate day-by-day but don't reflect disease progression over longer periods.
Trials where normals show pathology don't make sense. Lovestone instead searching for endophenotypes of histopath.
We're moving to complex biomarkers, multiple modalities.

A networking reception followed and the symposium came to a close.

Bruker and SISCAPA Assay Technologies Announce Joint Publication on SISCAPA-MALDI-TOF Mass Spectrometry for Biomarker Validation and Clinical Research

Biomarker Commons Newsbot — Mon, 30 Jan 2012 11:33:22 PST

Bruker Corporation and SISCAPA Assay Technologies, Inc. (SAT) today announced the publication of a study in the Journal of Proteome Research demonstrating that SISCAPA MALDI-TOF mass spectrometry provides excellent precision for quantitation of proteins of interest, such as high value protein biomarkers. The publication results from an ongoing collaboration between Bruker and SAT to develop MALDI-TOF as a high precision and high throughput mass spectrometric detection method for SISCAPA (Stable Isotope Standards and Capture by Anti-Peptide Antibodies) assays.

The collaboration aims to exploit the high throughput, robustness and ease of use of MALDI-TOF instruments as an alternative to nano-LC-MS technology currently used in many SISCAPA assays. While the ease of use and robustness of MALDI-TOF make it attractive for high throughput biomarker validation and pre-clinical studies, MALDI-TOF has generally been considered to have insufficient quantitative precision to be used in most clinical biomarker assays. In recent years, however, MALDI-TOF technology has advanced dramatically with high repetition rate lasers (up to 1 kHz) and automated self cleaning ion sources, resulting in faster, 24/7 operation with consistent results.

As shown in the paper published in the Journal of Proteome Research, the use of internal, isotopically labeled peptide standards in the SISCAPA assay yields very precise relative quantitation of peptides (CVs of 1-2%), comparing favorably with results obtained by the best conventional nano-LC-MS workflows. The elimination of complex and time-consuming nano-flow LC-MS separation greatly decreases the complexity of sample handling and sample introduction, which, together with advances in automated preparation of MALDI target plates, enables large scale biomarker verification studies currently considered impractical. The published results were obtained using a high- performance Bruker autoflex speed MALDI-TOF mass spectrometer, and unpublished results further indicate that assays for medium and high abundance proteins also are possible on the benchtop microflex MALDI-TOF used in Bruker’s MALDI Biotyper solution in clinical microbiology, and aimed at clinical and GMP environments.

Leigh Anderson, Ph.D., the CEO and founder of SISCAPA Assay Technologies, and inventor of SISCAPA, commented: "We are delighted to be working with Bruker, the leader in MALDI-TOF technology, to advance the precision and throughput of SISCAPA biomarker assays. Our joint paper demonstrates the very high precision of MALDI-TOF for peptide quantitation using internal standards, and establishes a solid basis for further exploring the utility of SISCAPA MALDI-TOF in biomarker verification and preclinical research. As a company devoted to the development and application of SISCAPA assays, we are excited that the addition of this robust and easy MALDI-TOF workflow to SISCAPA will not only increase the productivity of labs using SISCAPA, but also increase the adoption of SISCAPA assays by the biomarker research community."

Dr. Detlev Suckau, Director of Proteomics at Bruker Daltonics, added: "The results of the joint work prove that MALDI-TOF is very suitable for peptide and protein quantification in the 1-5 % CV range, if done properly. This is a very positive development, as previously many proteomics researchers may have considered MALDI-TOF as primarily a qualitative or semi-quantitative platform. We are very pleased to continue to work with Leigh Anderson and SISCAPA Assay Technologies on these ground-breaking biomarker quantification and validation developments. The results in this publication suggest that the use of the ‘LC-free’ SISCAPA-MALDI-TOF workflow in pre-clinical research is quite attractive. This is an emerging market for Bruker that will further increase the visibility of our very successful MALDI-TOF product line in biomedical research."

Study: The Precision of Heavy-Light Peptide Ratios Measured by MALDI-TOF Mass Spectrometry

Source: Bruker Corporation

Selventa Receives Patent for Method to Identify Biomarker Profiles

Walter Jessen — Fri, 27 Jan 2012 14:28:48 PST

Selventa, a biomarker discovery company that enables personalized healthcare through the stratification of patients based on disease-driving mechanisms, recently announced a US patent that relates methods and techniques that facilitate discovery of biomarkers, thus aiding in the development of predictive and prognostic diagnostic tests for therapeutics targeting complex multi-factorial diseases.

The Massachusetts-based company uses molecular patient data to identify key disease-driving mechanisms. This information allows for acceleration of the development process to clarify therapeutic and diagnostic decisions through identification and development of biomarkers for patient stratification.

Selventa's patent, U.S. Patent No 8,802,109, titled "Computer-aided Discovery of Biomarker Profiles in Complex Biological Systems," was issued on December 20, 2011. The patent describes a method of biomarker discovery using a model representative of one or more causative biophysical or biochemical relationships underlying a biological state in the biological system of interest. A candidate set of biological data is then compared against the model to distinguish a candidate biomarker for the biological state. A sample received from a patient can then be assayed for the presence of the candidate biomarkers to discern a biological state of the patient.

According to David de Graaf, Ph.D., President and CEO of Selventa:

Using the technique, biomarkers may be developed to predict efficacy or toxic effects of a drug. This may permit a researcher or physician to know, in advance, whether the presenting patient will benefit from or be harmed by administration of the drug. In addition, the patented technique facilitates the development of biomarkers as diagnostics for a disease, as a means of making treatment decisions or as a means of stratifying patients in a clinical trial. This will likely improve the success of clinical trials by screening for subjects that are more likely to benefit from the drug and avoiding those who are unlikely to respond.

Source: Selventa

Precision Therapeutics Enhances Their Straightforward Approach to Personalizing Cancer Care

Biomarker Commons Newsbot — Wed, 25 Jan 2012 08:00:00 PST

Precision Therapeutics, Inc. has recently expanded their BioSpeciFx product to include 21 clinically-relevant biomarkers to help physicians with their treatment decisions. This enhances Precision's approach to personalizing cancer care by offering additional molecular markers, including the recently FDA-approved ALK-FISH test.

By utilizing BioSpeciFx results in combination with Precision Therapeutics' ChemoFx in vitro drug response marker, physicians will receive both molecular and live-cell drug response information about a patient's tumor. Through the integration of these two tests, physicians can create a Comprehensive Tumor Profile, allowing them to more completely define their patient's cancer. In an effort to personalize treatment selection even further, BioSpeciFx and ChemoFx tests give physicians the ability to choose from suggested tumor-specific panels or to customize a report for each patient.

"The decision to add new biomarker tests to Precision Therapeutics' Comprehensive Tumor Profile was a direct result of market trends and customer requests," says Sean McDonald, CEO. "Precision is committed to producing multiple products that help physicians make difficult clinical decisions throughout the cancer care continuum. We are in the process of developing several additional tools to help us adhere to our mission of improving the odds of survival and the quality of life for cancer patients."

Source: PR Newswire

OPKO Health Acquires Next Generation Prostate Cancer Tests

Biomarker Commons Newsbot — Mon, 23 Jan 2012 20:00:00 PST

OPKO Health, Inc. yesterday announced the acquisition of an exclusive license from Arctic Partners Ab Oy (Turku, Finland) for two biomarkers in the kallikrein family which, used together with prostate specific antigen (PSA), can reduce the need for prostate biopsies by over 50%. These novel biomarkers were developed by investigators at the University of Malmo, Sweden, University of Turku, Finland, and Memorial Sloan Kettering Cancer Center, New York. The research results indicate that these markers can predict initial biopsy results in men suspected of having prostate cancer; they have been tested in over 8,000 men and were independently validated in the European Randomized Study of Prostate Cancer Screening (Rotterdam).

The value of PSA testing in men who would otherwise not be screened was assessed in the European Randomized Study of Prostate Cancer. Approximately 182,000 men in seven European countries were randomized for PSA screening or to serve as controls. At a median follow-up of approximately 9 years, PSA screening was associated with a 20% reduction in deaths from prostate cancer. Despite this finding, it is noted that 48 men would need to be treated to prevent one death from prostate cancer. While quite specific to the prostate gland, PSA is not specific for prostate cancer. As a result, in the U.S., an estimated 750,000 men receive unnecessary prostate biopsies annually. The OPKO test panel will combine PSA and two novel kallikrein markers to provide significantly greater accuracy.

"These two new biomarkers provide us with a unique opportunity to greatly improve the value of prostate cancer screening. The higher specificity of our new panel of markers will provide better and more efficient outcomes, while lowering overall costs," said Phillip Frost, M.D., Chairman and CEO of OPKO Health.

"As a physician who sees many men with elevated PSA levels, I believe this novel panel of kallikrein biomarkers will help us to greatly reduce the number of unnecessary prostate biopsies performed with their attendant side effects and added costs. The research supporting the value of this panel is sound, and has been validated in thousands of patients in different clinical settings, including initial PSA screening, repeated screenings, and in men with a previous negative biopsy. I believe this panel of tests will eventually replace PSA measures alone for the early detection of prostate cancer that needs to be treated, helping us to avoid dealing with small, indolent cancers that should be left alone," said Peter Scardino, M.D. (Chief of Surgery, Memorial Sloan Kettering Cancer Center, New York).

Source: OPKO

Evotec and Harvard University Expand Strategic Alliance into Kidney Disease

Biomarker Commons Newsbot — Thu, 19 Jan 2012 08:00:00 PST

Evotec AG recently announced a second strategic alliance with Harvard University, this time including Brigham and Women's Hospital aimed at discovering and developing new biomarkers and treatments in the field of kidney disease. The first successful collaboration 'CureBeta' was established in March 2011 to develop new diabetes therapies targeting beta cell regeneration.

Now Harvard, Brigham and Women's Hospital and Evotec also bring together extensive expertise and know-how in kidney biology, physiology and disease along with a unique set of tools to identify, validate and develop candidate targets and biomarkers. The alliance will pursue systematic and unbiased approaches towards the identification of kidney disease relevant mechanisms with particular interest in mechanisms with disease modifying potential. This program 'CureNephron' is designed to deliver and exploit novel therapeutic targets as well as biomarkers that allow more accurate diagnosis, monitoring and treatment of chronic and acute kidney disease.

Advanced chronic kidney disease (CKD) and severe forms of acute kidney injury have very limited treatment options and are associated with high morbidity and mortality. Patients with end stage renal disease (ESRD) suffer from complete loss of kidney function and have to be treated by dialysis, a costly and burdensome procedure with limited efficacy and generally poor prognosis. Novel therapeutic approaches are needed that have the potential to protect and restore the function of key kidney cell types aiming to slow and reverse disease progression for patients with non-dialysis dependent CKD as well as patients with ESRD on dialysis.

"We are extremely proud to work with Dr. Andy McMahon and Dr. Ben Humphreys, who are highly accomplished scientists and clinicians in this exciting field. Together with Evotec scientists they will be part of a uniquely cross functional team covering kidney biology, physiology, and disease as well as leading drug discovery expertise. Our combined efforts will lead to new insights into kidney disease biology and fuel a pipeline of commercially exciting drug candidates in acute and chronic kidney disease," said Dr. Cord Dohrmann, CSO of Evotec.

Dr. Andy McMahon, Professor at Harvard University, said "The primary mechanisms leading and driving the development of kidney damage have not been systematically explored. We aim to comprehensively screen for these mechanisms looking at how individual kidney cell types respond to acute and chronic insults during various stages of disease progression as well as during the recovery process."

Dr. Ben Humphreys, associate physician in the Renal Division, Brigham and Women's Hospital and a professor at Harvard Medical School, added: "As chronic diseases such as diabetes continue to grow at alarming rates there is an ever increasing need to develop new treatment options for diabetes related co-morbidities which include end stage renal disease. In collaboration with Evotec, we are enthusiastic about identifying and exploring new mechanisms that have the potential to modify disease progression and hopefully produce first-in-class therapeutics for the treatment of kidney disease."

"We're very pleased to expand our alliance which is testimony to a highly productive working relationship with Evotec in diabetes", said Isaac T. Kohlberg, Harvard's Chief Technology Development Officer and head of its Office of Technology Development. "This new collaboration involving researchers from Harvard University and Brigham and Women's Hospital as well as Evotec is a great example of joining forces across traditional academic and industrial boundaries to more rapidly advance groundbreaking science to the stage of translational medicine and ultimately patients."

Source: Evotec

Quintiles Forms New Biomarker Research and Development Company

Biomarker Commons Newsbot — Wed, 18 Jan 2012 04:00:00 PST

Continuing its commitment to advancing personalized medicine by offering world-leading experts and cutting-edge tools, Quintiles today announced that it has invested in a new company formed to provide oncology consulting services and new cancer biomarkers, the key to scientific selection of the right drug for the right patient.

The company, Oxford Cancer Biomarkers, will develop biomarkers using CancerNav, a proprietary DNA- and protein-based assay technology platform invented by Nick La Thangue, Ph.D., Chair of Cancer Biology at Oxford University. David Kerr, CBE, DSc, M.D, FMedSci., Professor of Cancer Medicine at the University of Oxford and a world-renowned expert in cancer clinical research and policy development, will serve as the new company’s Chief Medical Officer.

Quintiles is the largest shareholder in Oxford Cancer Biomarkers; other major shareholders are the University of Oxford, and Professors La Thangue and Kerr.

“Biomarkers hold great promise to improve trial success rates by identifying patient sub-groups most likely to respond to treatment, increasing the probability of trial success and improving patient safety,” said Ben Cons, Vice President, Quintiles Corporate Development. “Quintiles’ investment in Oxford Cancer Biomarkers is further evidence of our commitment to provide biopharma and healthcare service providers with the tools, expertise and services needed to increase R&D productivity and speed, and better the lives of patients.”

Professor Kerr, who recently finished his term as President of the European Society of Medical Oncology, said: “We see this as a fantastic opportunity to pursue our vision of personalized medicine in which we aim to identify those cancer patients who are likely to benefit most from treatment. Our association with Quintiles is greatly welcomed and widens our access to some of the best cancer drug development teams on the planet.”

Professor La Thangue said: “Today’s announcement provides early and strong endorsement of our proprietary biomarker platform, CancerNav, which can rapidly generate predictive biomarkers for cancer drugs. Quintiles is the ideal partner to leverage our clinical and biomarker expertise.”

Oxford Cancer Biomarkers, with offices in Oxford and Reading, U.K., will have a strategic relationship with Quintiles Consulting and Quintiles Global Laboratories, which have the capabilities and expertise to operationalize the consulting and biomarker R&D innovations from Oxford Cancer Biomarkers for the benefit of biopharma companies globally.

Source: Quintiles

New Test Spots Early Signs of Inherited Metabolic Disorders

Biomarker Commons Newsbot — Wed, 11 Jan 2012 17:00:00 PST

A team of scientists, led by researchers at the University of California, San Diego School of Medicine and Zacharon Pharmaceuticals, have developed a simple, reliable test for identifying biomarkers for mucopolysaccharidoses (MPS), a group of inherited metabolic disorders that are currently diagnosed in patients only after symptoms have become serious and the damage possibly irreversible. The findings will be published online January 8 in the journal Nature Chemical Biology.

MPS is caused by the absence or malfunctioning of a lysosomal enzyme required to break down and recycle complex sugar molecules called glycosaminoglycans, which are used to build bone, tendons, skin and other tissues. If not degraded and removed, glycosaminoglycans can accumulate in cells and tissues, resulting in progressive, permanent damage affecting appearance, physical abilities, organ function and often mental development in young children. The effects range from mild to severe.

There are 11 known forms of MPS, each involving a different lysosomal enzyme. A number of treatments exist, including enzyme replacement therapy and hematopoietic stem cell transplantation, but efficacy depends upon diagnosing the disease and its specific form as early as possible. That has been problematic, said Jeffrey D. Esko, PhD, professor in the Department of Cellular and Molecular Medicine and co-director of the Glycobiology Research and Training Center at UC San Diego.

“The typical time from seeing first symptoms to diagnosis of MPS is about three years. Since the early signs of disease are common childhood issues like ear infections and learning disorders, the disease is usually not immediately recognized,” Esko said.

“A child often has multiple visits with their pediatrician. Eventually they are referred to a metabolic disease specialist, where rare diseases are considered. It takes an expert to identify MPS and its most likely form in each patient. Every subclass of MPS has its own specific diagnostic test, so developing better diagnostics is an essential part of effective treatment. ”

In their paper, the scientists describe an innovative method to detect tell-tale carbohydrate structures specific to glycosaminoglycans in the cells, blood and urine of MPS patients. The biomarker assay identifies all known forms of the disease.

Esko is collaborating with Zacharon Pharmaceuticals, a San Diego-based biotechnology company, to develop a commercial diagnostic assay for differentiating forms of MPS from urine and blood samples, a screening test for newborns and a tool for measuring the biochemical response of MPS patients to existing and novel therapies.

“Since the severity of the disease is highly variable among patients, this could provide a tool that a doctor can use to optimize dosing or treatment,” said Brett Crawford, Vice President for Research at Zacharon. “Currently, all patients are treated with the same dose of drug.”

The biomarker test may also be used to discover new forms of MPS and better characterize existing ones.

DISCLOSURE: Esko co-founded Zacharon Pharmaceuticals in 2004 with Brett E. Crawford and Charles Glass. He is a scientific advisor to the company.

Co-authors include Roger Lawrence and William C. Lamanna, UCSD Department of Cellular and Molecular Medicine, Glycobiology Research and Training Center; Jillian R. Brown, James R. Beitel and Brett E. Crawford, Zacharon Pharmaceuticals; Geert-Jan Boones and Kanar Al-Mafraji, University of Georgia, Athens.

Funding for this research came, in part, from the National Institutes of Health, a Kirschstein National Research Service Award and the National MPS Society.

Study: Disease-specific non-reducing end carbohydrate biomarkers for mucopolysaccharidoses.

Source: UC San Diego News Center

Dako and Amgen to Collaborate in Development of a Companion DX

Biomarker Commons Newsbot — Wed, 11 Jan 2012 14:12:36 PST

Dako, a world leading independent cancer diagnostic supplier with 45 years of experience in pathology, announced today that it has entered into a development and collaboration agreement with Amgen Inc. to develop a diagnostic test for an Amgen cancer drug candidate targeted for a rare and deadly cancer.

“I am proud to announce that Dako and Amgen have succeeded in putting together a business model that supports the concurrent development of drug and diagnostics for a low incidence cancer – something that has been difficult to achieve in the industry until now,” says Lars Holmkvist, Dako’s chief executive officer.

“This new collaboration brings hope to cancer patients suffering from this rare form of cancer,” he adds.

Today’s announcement marks the continuation of Dako’s commitment to advance companion diagnostics by collaborating with strong partners in the pharmaceutical sector. Over the past 24 months agreements with AstraZeneca, Bristol-Myers Squibb and Genentech have been announced.

“Our agreement with Amgen is one of several partnerships that Dako has entered with pharma companies to enable the development of diagnostic tests to predict which patients are most likely to respond to specific treatments,” says Lars Holmkvist.

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

Foundation Medicine Announces Collaboration with Sanofi

Biomarker Commons Newsbot — Wed, 11 Jan 2012 14:01:06 PST

Foundation Medicine, Inc., a molecular information company that brings comprehensive cancer genome analysis to routine clinical care, today announced the initiation of a strategic collaboration with Sanofi. Foundation Medicine will use their genomic sequencing and analytic capabilities to identify genetic biomarkers and potential companion diagnostics for select Sanofi oncology drug candidates. This is Foundation Medicine’s fifth major pharmaceutical company alliance, each of which utilizes the company’s comprehensive technology for providing a fully informative molecular cancer profile.

“Sanofi and Foundation Medicine share a commitment to new clinical solutions that address individual patient needs,” said Donald A. Bergstrom, M.D., Ph.D., associate vice president and global head, translational and experimental medicine at Sanofi. “Sanofi is focused on increasing innovation in R&D through networks of creativity that can harness complex science to enable targeted therapies for patients. Foundation Medicine is an ideal collaborator in this mission.”

“Foundation Medicine has rapidly become a molecular analysis partner of choice for both academia and the biopharma industry,” said Michael J. Pellini, M.D., president and chief executive officer of Foundation Medicine. “Our unique capability to correlate clinical data with specific genomic alterations has enabled these innovative partnerships in genomic discovery for cancer treatment. Targeted cancer therapeutics routinely demonstrate improved clinical safety and efficacy when matched with the patients most likely to benefit, and we believe this alliance with Sanofi will help catalyze the development of their targeted candidates.”

Foundation Medicine has signed five strategic biopharmaceutical alliances to date around their complete molecular information capabilities. These partnerships complement Foundation Medicine’s core cancer diagnostics capability, a comprehensive cancer genomic test that provides physicians with genomic information that may help match patients with treatments or clinical trials specific for the genomic profile of their tumor.

Source: Foundation Medicine