Biomarker Commons

Early Biomarker for Pancreatic Cancer Identified

Biomarker Commons Newsbot — Tue, 15 May 2012 18:06:09 +0000

Researchers at the University of California, San Diego School of Medicine and Moores Cancer Center have identified a new biomarker and therapeutic target for pancreatic cancer, an often-fatal disease for which there is currently no reliable method for early detection or therapeutic intervention. The paper will be published May 15 in Cancer Research.

Pancreatic ductal adenocarcinoma, or PDAC, is the fourth-leading cause of cancer-related death. Newly diagnosed patients have a median survival of less than one year, and a 5-year survival rate of only 3 to 5 percent. Therefore, biomarkers that can identify early onset of PDAC and which could be viable drug targets are desperately needed.

"We found that a kinase called PEAK1 is turned on very early in pancreatic cancer,” said first author Jonathan Kelber, PhD, a postdoctoral researcher in the UCSD Department of Pathology and Moores Cancer Center. “This protein was clearly detected in biopsies of malignant tumors from human patients – at the gene and the protein levels – as well as in mouse models.”

PEAK1 is a type of tyrosine kinase – an enzyme, or type of protein, that speeds up chemical reactions and acts as an “on” or “off” switch in many cellular functions. The fact that PEAK1 expression is increased in human PDAC and that its catalytic activity is important for PDAC cell proliferation makes it an important candidate as a biomarker and therapeutic target for small molecule drug discovery.

In addition to showing that levels of PEAK1 are increased during PDAC progression, the scientists found that PEAK1 is necessary for the cancer to grow and metastasize.

“PEAK1 is a critical signaling hub, regulating cell migration and proliferation,” said Kelber. “We found that if you knock it out in PDAC cells, they form significantly smaller tumors in preclinical mouse models and fail to metastasize efficiently.”

The research team, led by principal investigator Richard Klemke, PhD, UCSD professor of pathology, studied a large, on-line data base of gene expression profiles to uncover the presence of PEAK1 in PDAC. These findings were corroborated at the protein level in patient biopsy samples from co-investigator Michael Bouvet, MD, and in mouse models developed by Andrew M. Lowy, MD, both of the UCSD Department of Surgery at Moores Cancer Center.

While many proteins are upregulated in cancers of the pancreas, there has been limited success in identifying candidates that, when inhibited, have potential as clinically approved therapeutics. However, the researchers found that inhibition of PEAK1-dependent signaling sensitized PDAC cells to existing chemotherapies such as Gemitabine, and immunotherapies such as Trastuzumab.

“Survival rates for patients with pancreatic cancer remain low,” said Bouvet. “Therefore, earlier detection and novel treatment strategies are very important if we are going to make any progress against pancreatic cancer. Since current therapies are often ineffective, our hope is that the findings from this research will open up a new line of investigation to bring a PEAK1 inhibitor to the clinic.”

Study: KRas Induces a Src/PEAK1/ErbB2 Kinase Amplification Loop That Drives Metastatic Growth and Therapy Resistance in Pancreatic Cancer

Source: UC San Diego Health System

New US Patent Grant for ValiRx’s Cancer Screening Gene Biomarker

Biomarker Commons Newsbot — Tue, 15 May 2012 17:52:19 +0000

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to announce that a method for cancer screening, using specific gene biomarkers in the field of genetics and oncology, has recently received patent approval by the United States' patent office.

The granting of this latest patent means that ValiRx now has biomarker patent protection in both the US and across Europe, alongside granted and pending patents for its therapeutic technologies across Europe, the US, Canada and Australia.

This latest patent concerns the method or process by which gene biomarkers can be used in the detection or identification of a patient’s susceptibility to cutaneous T-cell lymphoma (a type of non-Hodgkin’s lymphoma) and also for improving treatment methods.

The use of biomarkers in oncology therapeutics is one of the fastest growing areas in cancer diagnosis and monitoring. In combination with specific therapeutic approaches, it is the growth of personalised medicine, particularly in cancer research, alongside support from regulatory agencies that are the key factors behind the increase in demand for biomarkers.

Personalised therapeutics are gaining popularity due to their ability to provide customised treatment to patients based on their genetic and medical profile. Since biomarkers help in predicting patient response to a compound, personalised medicines are increasingly using biomarkers to identify the patient population set that is more likely to respond to a particular drug therapy. Personalised medicines are also increasingly being used along with targeted cancer therapies and as personalised medicines gain more importance and popularity, the demand for suitable companion biomarkers is also expected to increase.

Dr Satu Vainikka, CEO, commented: “I am delighted we have received the US patent office’s approval for our gene biomarkers’ activity. This grant significantly strengthens our patent portfolio and it is a particularly pleasing endorsement, coming as it does from under the rigorous scrutiny of the US patent authorities. I am very pleased by the continuing validation of our technologies and of our approach to therapeutics and biomarkers themselves and I believe this patent grant further underlines the importance of a genetic approach to the management and detection of oncological diseases.”

Thermo Fisher Scientific Acquires All Rights for Pre-eclampsia Biomarker from Nephromics

Biomarker Commons Newsbot — Tue, 15 May 2012 17:46:43 +0000

Thermo Fisher Scientific Inc., the world leader in serving science, today announced it has signed an asset purchase agreement with Nephromics LLC, which includes a patent license for exclusive rights to use PlGF (Placental Growth Factor) for the diagnosis of pre-eclampsia or eclampsia. Clinical trials have shown that PlGF supports the diagnosis and risk prediction for preeclampsia (PE). Thermo Fisher will develop PlGF as an immunoassay on its own KRYPTOR™ platform and, through management of several sublicenses under the acquired license, will strengthen its global position in prenatal screening by expanding the availability of the assay through license partners.

According to the World Health Organization (WHO), PE occurs in up to 8 percent of pregnancies worldwide and is a life-threatening disorder that occurs only during pregnancy and the postpartum period. Pre-eclampsia and related disorders such as HELLP syndrome and eclampsia are most often characterized by a rapid rise in blood pressure that can lead to seizure, stroke, multiple organ failure and death of the mother and/or baby. Global health care costs for pre-eclampsia are estimated to be $3 billion per year. Current methods for identification of pre-eclampsia – regular measurements of blood pressure and protein testing in the urine during routine prenatal visits – deliver PE diagnoses after the condition has reached an advanced status.

“The measurement of maternal serum PlGF at 11-13 weeks of gestation is essential in providing an excellent screening test both for chromosomal defects and for pre-eclampsia,” said Kypros Nicolaides, professor of Fetal Medicine at Harris Birthright Research Centre for Fetal Medicine, King’s College Hospital, London, UK, and Department of Fetal Medicine, University College Hospital, London, UK, and founder of Fetal Medicine Foundation (FMF). “Early identification of the pregnancies at high risk for PE gives the option for therapeutic interventions with such drugs as low-dose aspirin, which substantially reduces the prevalence of the disease.”

“Taking into account the fatal consequences of pre-eclampsia, an assay for testing PlGF may offer a much better outcome for patients with this disorder,” said Andy Thomson, president of the Thermo Fisher’s Specialty Diagnostics business. “Levels of PlGF in patients with PE are significantly lower than in non-preeclamptic pregnancies. This test is an additional tool in PE screening and will help identify women at risk earlier and, therefore, support therapy management.”

The addition of this PlGF assay is a complement to Thermo Fisher’s already existing prenatal screening portfolio (PAPP-A, Free βhCG, AFP, hCG+β, Fast Screen pre I plus software) and ongoing research and development activities in that field. Market entry for the new assay PlGF is planned for the first quarter of 2013.

Source: Thermo Fisher Scientific

OPKO Health Enters into License Agreement with International Health Technology for Next Generation Prostate Cancer Biomarker Panel

Biomarker Commons Newsbot — Tue, 08 May 2012 00:07:25 +0000

OPKO Health, Inc. (NYSE:OPK) today announced execution of a license agreement granting International Health Technology, Ltd. (Cambridge, England) the right to offer OPKO's novel panel of kallikrein biomarkers and associated algorithm for the detection of prostate cancer in a laboratory setting in the U.K., Ireland, Sweden and Denmark. The OPKO panel represents the culmination of a decade of research by scientists in Europe and the U.S. and has been demonstrated in over 10,000 patients to predict the probability of cancer-positive biopsy in men suspect for prostate cancer. Studies have shown use of the panel could eliminate a significant amount of unnecessary prostate biopsies, demonstrating a reduction of over 50%.

International Health Technology, through close cooperation with some of the largest private hospitals chains in the UK and abroad, has access to world class private facilities and specialists to provide testing services for corporate clients in the private sector.

"The partnership with IHT will offer OPKO a unique opportunity for our kallikrein panel in select initial markets," said Phillip Frost, M.D., Chairman and CEO of OPKO Health. "We believe this technology will enable IHT to provide the patients they serve with better and more efficient healthcare, while lowering overall costs. We hope eventually that this panel will become the standard of care in prostate cancer screening."

Source: OPKO Health

Genomic Health and OncoMed Announce Strategic Alliance for Biomarker Research and Discovery Using Next Generation Sequencing

Biomarker Commons Newsbot — Tue, 08 May 2012 00:01:42 +0000

Genomic Health, Inc. (Nasdaq: GHDX) and OncoMed Pharmaceuticals, Inc. (OncoMed) today announced a strategic alliance to use Next Generation Sequencing (NGS) to identify biomarkers that can be applied to the clinical development of OncoMed's novel antibody cancer therapeutics.

Under the terms of the agreement, OncoMed will provide Genomic Health with breast, prostate, colon and lung tumor samples. A subset of these tumors will include OncoMed's extensive bank of proprietary xenograft models derived from freshly resected human cancers. Genomic Health will apply its industry-leading NGS capabilities; including proprietary sample preparation, high-throughput sequencing and bioinformatics, to discover biomarkers that can help identify subsets of patients that will more likely respond to cancer therapeutics targeting the Notch, Wnt and other pathways critical to cancer stem cells.

"Working with like-minded, innovative cancer companies, we can utilize our proven NGS-based diagnostic research and development infrastructure to help optimize patient selection to accelerate clinical development of targeted cancer treatments," said Steven Shak, M.D., chief medical officer, Genomic Health. "This collaboration supports our long-term vision and belief that, molecular diagnostics are inherent for bringing quality, personalized care to all cancer patients from diagnosis through survivorship."

"Our priority is not only to develop therapeutic antibodies but to target their clinical use in the subsets of patients most likely to benefit through focused clinical plans, which include patient selection strategies at early stages of testing," said Paul J. Hastings, president and chief executive officer of OncoMed. "We believe the collaboration with Genomic Health will accelerate our already existing efforts of developing predictive biomarkers alongside the development of our anti-cancer stem cell therapeutics."

Source: Genomic Health

Videos: Recent Advances in Biomarkers of Parkinson's Disease

Walter Jessen — Mon, 07 May 2012 15:08:59 +0000

The Covance Symposium Recent Advances in Biomarkers of Parkinson’s Disease presented at the 2011 Society for Neuroscience Conference is now available to watch on the Covance website. Listen to discussions regarding recent innovations in imaging, genomic, proteomic, and fluid biomarkers of Parkinson's disease and their potential application to the clinic.

Urate As an Emerging Biomarker in PD: A Cellular Study
Sara Cipriana, PhD
Massachusetts General Hospital
Molecular Neuroimaging: Developing a Translational Toolbox for Parkinson's Disease
Ken Marek, MD
Institute of Neurodegenerative Disorders Molecular Neuroimaging
Pathway Analyses: Converging the Genetic Complexity of Parkinson's Disease
Jeffery Vance, MD, PhD,
Dr. John T. Macdonald Foundation Department of Human Genetics
John P. Hussman Institute for Human Genomics, University of Miami, Miller School of Medicine
Morris K. Udall Parkinson Disease Research Center of Excellence
Risk Assessment and Biomarkers for PD
Thomas Montine, MD, PhD
Neuropathology, University of Washington Medical Center
Characterization of Alpha Synuclein Forms in Parkinson's, Dementia with Lewy Bodies, and Normal Human Brain Tissue
Michael D. Knierman
Integrative Biology, Eli Lilly and Company

Whether you need a single study or a comprehensive discovery and translational services program, the Covance Biomarker Center of Excellence offers extensive resources and industry expertise to help you solve your toughest biomarker development challenges.

AssureRx Health Launches Personalized Medicine Test for ADHD

Biomarker Commons Newsbot — Mon, 07 May 2012 14:07:55 +0000

AssureRx Health, Inc. today announced it has launched a personalized medicine test for the growing number of children and adults diagnosed with attention deficit hyperactivity disorder (ADHD). The new pharmacogenomic test can assist clinicians with important medication decisions that result from genomic differences in how individual patients tolerate ADHD medications.

GeneSightRx ADHD analyzes variations in three genes that influence how a patient might metabolize certain medications used to treat ADHD in children and adults. Understanding a patient's unique genomic profile may help a clinician individualize a patient's medication selection and avoid side effects that often occur with these medications. The test provides objective, evidence-based information for clinicians to personalize medication selection for each patient.

The GeneSightRx ADHD analysis is based on pharmacogenomics, FDA-approved manufacturer's drug labels, published peer reviewed research, and proven pharmacology. The new ADHD test adds to the company's treatment decision support products that include GeneSightRx Psychotropic, a psychiatric pharmacogenomic product that tests important genomic variants affecting metabolism to psychiatric medications for individual patients.

ADHD diagnoses increased 66 percent from 6.2 million in 2000 to 10.4 million in 2010, according to a study published in the March/April 2012 issue of Academic Pediatrics. ADHD is the most common childhood disorder and can continue into adulthood. Symptoms of ADHD include an inability to stay focused or pay attention, difficulty controlling behavior, and hyperactivity.

"ADHD is a neurobehavioral disorder affecting millions of children and adults. With the introduction of GeneSightRx ADHD, clinicians now have an objective, evidence-based tool for individualizing ADHD medications," said James S. Burns, president and CEO of AssureRx Health. "Our goal is to build a portfolio of innovative pharmacogenomic and other treatment decision support products to help physicians individualize the treatment of patients with neuropsychiatric and other disorders."

When a clinician orders the test, a DNA sample is taken from the patient with a simple, non-invasive cheek swab. The specimen is sent overnight to AssureRx Health's CLIA-certified and CAP-accredited laboratory. The ordering clinician receives the patient report via a secure online portal that presents the patient's genomic information in an easy-to-read and clinically actionable format.

Source: AssureRx

QLIDA Diagnostics Developing a Mobile Cardiac Biomarker Testing Device

Walter Jessen — Fri, 04 May 2012 03:58:57 +0000

A spinout of Drexel University called QLIDA Diagnostics is developing a mobile cardiac biomarker testing device for use in emergency rooms to rapidly determine whether someone is having a heart attack.

The mobile diagnostic test uses a small blood sample to measure the cardiac biomarker troponin. Under stress, the protein is released into the bloodstream and increases in concentration with increased stress levels.

QLIDA Diagnostics claims the test is more sensitive and cost-effective than others being developed. Moreover, it can test additional biomarkers simultaneously for heart attack such as brain natriuretic peptide or BNP.

QLIDA Diagnostics CEO Michael Boyce-Jacino said that hospitals could more accurately triage patients and reduce emergency room wait times. In addition, the test could be used to indicate the risk of heart attack in the future.

Source: MedCity News

Navidea Biopharmaceuticals Announces Participation in Alzheimer's Disease Scientific Meetings

Biomarker Commons Newsbot — Wed, 02 May 2012 21:17:15 +0000

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB), a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that Dr. Thomas Tulip, Navidea's EVP and Chief Business Officer, was invited to present at two Alzheimer's Disease (AD) conferences: Alzheimer's Disease Neuroimaging Initiative (ADNI) Private Partner Scientific Board meeting and the German Nuclear Medicine Convention. Focused on Navidea's AZD4694 radiopharmaceutical imaging biomarker for the detection of cerebral amyloid in Alzheimer's disease (AD) patients, Dr. Tulip's presentations highlighted AZD4694 background, status and strong attributes, such as high sensitivity and low non-target accumulation. These and other characteristics of the agent appear to make it an excellent candidate as a biomarker to facilitate enhanced therapeutic drug development.

The ADNI meeting was held on April 22, 2012 in New Orleans, LA in conjunction with this year's American Academy of Neurology convention and brings together scientists from academia, government and the private sector to discuss the progress in the field of AD research. The goal of ADNI, which is funded by the National Institutes of Health (NIH) and a consortium of pharmaceutical companies, is to define the rate of progress of Alzheimer's disease, to develop improved methods for clinical trials in this area, and to provide a large database which will improve design of treatment trials. The ADNI study is following the rate of change of cognition, function, brain structure and function, and biomarkers in elderly controls, subjects with mild cognitive impairment, and those diagnosed with AD.

The German Nuclear Medicine Convention is being held April 25-28, 2012 in Bremen, Germany. Dr. Tulip's presentation entitled "AZD4694: A Highly Sensitive 2nd Generation AB Biomarker" will be held on April 26th in the New Tracers for Amyloid-Imaging in a Clinical Setting session.

Source: Navidea

BGI Announces Cloud-based DNA Sequencing Service Powered by NVIDIA GPUs

Walter Jessen — Wed, 02 May 2012 21:02:59 +0000

The technology company NVIDIA, best known for its graphics processing units (GPUs), recently announced that BGI is launching a service that will enable researchers worldwide to perform affordable next-generation sequencing (NGS) bioinformatics analysis in the cloud.

The new "EasyGenomics" service combines an intuitive user interface with BGI's automated pipeline analysis, software and tools. These are integrated with the industry's largest sequencing platform to provide everything biologists, bioinformaticists and, ultimately, physicians need to submit and receive an automated analysis of DNA sequencing data.

EasyGenomics leverages NVIDIA GPUs, which accelerates the processing of data from days to hours compared with a CPU-based system.

Dr. Lin Fang, vice president at BGI, anticipates widespread adoption of the EasyGenomics service:

By enabling larger numbers of researchers to accelerate DNA sequencing data more easily and affordably, we hope to help facilitate the use of genomics for clinical diagnostics as a practical component of health care, as well as for complex disease research. GPU acceleration enables scientists to analyze DNA sequencing data faster than was ever possible, reducing the time from five days to just five hours. Once fully deployed in the cloud, we anticipate EasyGenomics could one day revolutionize genomics research.

The EasyGenomics cloud service features hybrid computing systems powered by NVIDIA Tesla M2070 and M2075 GPUs, which accelerate the DNA sequencing data analysis in conjunction with system CPUs. BGI plans to upgrade the EasyGenomics service with hundreds of additional NVIDIA Tesla GPUs when it is fully deployed, at which time it is expected to support thousands of users.

Sumit Gupta, senior director of the Tesla business at NVIDIA, sees the EasyGenomics service as a solution to manage DNA big data:

This could be the year of the $1,000 genome due to rapid decline in sequencing costs. We will soon be drowning in a deluge of data from the genome sequencers. BGI's EasyGenomics service uses the power of GPU computing to provide an affordable and easy-to-use method for scientists to crunch through this new genomics big data problem and get us that much closer to effective and affordable individualized treatments.

Source: NVIDIA