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The Michael J. Fox Foundation Funds Research to Develop Parkinson’s Blood Test

Research being performed by Durin Technologies, Inc., exploring the development of a novel blood test for Parkinson’s disease was recently awarded a second grant from The Michael J. Fox Foundation for Parkinson’s Research.

Genalyte and Barbara Davis Diabetes Center Collaborate to Advance Multiplexed Antigen Panel for Early Diagnosis of Type 1 Diabetes

Genalyte, Inc. recently announced the launch of its Type 1 Diabetes (T1D) antigen panel that runs on the Maverick Detection System. The Genalyte T1D antigen panel is the first multiplexed assay that measures seven autoantibodies associated with the destruction of pancreatic islet cells seen in type 1 diabetes. In a related development, Genalyte reported that it is collaborating with the Barbara Davis Center for Childhood Diabetes (BDC) at the University of Colorado School of Medicine to further develop and test multiplexed antigen panels for the early detection of T1D.

The Genalyte T1D antigen panel was developed as part of the first phase of a Small Business Innovation Research (SBIR) grant awarded to Genalyte to develop multiplexed assays for the early detection and monitoring of type 1 diabetes. The $500,000 grant from the National Institute of Diabetes and Digestive and Kidney Diseases also provides support for expansion of the approach to allow autoantibody response profiling by multiple criteria, which is expected to enhance the ability of researchers and clinicians to detect and monitor the development of the disease.

Martin Gleeson, PhD, Chief Scientific Officer of Genalyte, noted, “The pioneering work of Drs. George Eisenbarth and Liping Yu at BDC established assays for the measurement of islet autoantibodies. These rogue elements of the immune system eventually destroy the pancreatic islet cells that produce insulin. The unique capabilities of our Maverick detection platform have the potential to provide researchers and clinicians with tools to detect and track this process from an early stage, when interventions to interrupt the disease process may be feasible.”

An estimated three million individuals in the U.S. have T1D, an autoimmune disorder that leads to life-long dependence on insulin injections. New disease-modifying therapies may have the potential to reduce or stop the destruction of islet cells in patients at risk of developing T1D. The availability of tools to identify these patients early in the disease process would facilitate the development and use of these preventative therapies.

“We are pleased to offer our innovative T1D antigen panel to diabetes researchers worldwide at the same time that we are working with Dr. Liping Yu and his lab at the Barbara Davis Diabetes Center to expand the utility of the approach,” added Dr. Gleeson. “BDC is a long-time leader in the quest to develop curative therapies for type 1 diabetes, and we are delighted to collaborate with them to develop the tools that may help make this dream a reality.”

The Genalyte T1D antigen panel requires only a 2 to 5 μL serum or plasma sample and provides results in less than 15 minutes, without the use of dyes, fluorescent probes or radioactive labels. The T1D panel measures autoantibodies to insulin, proinsulin, GAD 65, GAD 67, IA-2 (PTPRN, ICA512), phogrin (PTPRN2, IA-2ß) and ZnT8 (SLC30A8). For more information, visit http://genalyte.com/maverick-type-1-diabetes-t1d-assay-kit/.

Other commercially available tests for the Maverick Detection System include MT-ADA, ENA 4, ENA 6 and ANA 14 assay kits. Additionally, Genalyte offers researchers a Custom Spotting Service that loads proteins supplied by customers, such as antibodies, peptides, biomarkers, cytokines and antigens, on to standard-format Genalyte chips that are ready to be run on the Maverick System.

Maverick assays are currently available for research use only.

Source: Genalyte

New Research from SRI Points to Biomarker that Could Track Huntington’s Disease Progression

A hallmark of neurodegenerative diseases such as Alzheimer’s, Parkinson’s and Huntington’s is that by the time symptoms appear, significant brain damage has already occurred—and currently there are no treatments that can reverse it. A team of SRI International researchers has demonstrated that measurements of electrical activity in the brains of mouse models of Huntington’s disease could indicate the presence of disease before the onset of major symptoms. The findings, “Longitudinal Analysis of the Electroencephalogram and Sleep Phenotype in the R6/2 Mouse Model of Huntington’s Disease,” are published in the July 2013 issue of the neurology journal Brain, published by Oxford University Press.

SRI researchers led by Stephen Morairty, Ph.D., a director in the Center for Neuroscience in SRI Biosciences, and Simon Fisher, Ph.D., a postdoctoral fellow at SRI, used electroencephalography (EEG), a noninvasive method commonly used in humans, to measure changes in neuronal electrical activity in a mouse model of Huntington’s disease. Identification of significant changes in the EEG prior to the onset of symptoms would add to evidence that the EEG can be used to identify biomarkers to screen for the presence of a neurodegenerative disease. Further research on such potential biomarkers might one day enable the tracking of disease progression in clinical trials and could facilitate drug development.

“EEG signals are composed of different frequency bands such as delta, theta and gamma, much as light is composed of different frequencies that result in the colors we call red, green and blue,” explained Thomas Kilduff, Ph.D., senior director, Center for Neuroscience, SRI Biosciences. “Our research identified abnormalities in all three of these bands in Huntington’s disease mice. Importantly, the activity in the theta and gamma bands slowed as the disease progressed, indicating that we may be tracking the underlying disease process.”

EEG has shown promise as an indicator of underlying brain dysfunction in neurodegenerative diseases, which otherwise occurs surreptitiously until symptoms appear. Until now, most investigations of EEG in patients with neurodegenerative diseases and in animal models of neurodegenerative diseases have shown significant changes in EEG patterns only after disease symptoms occurred.

“Our breakthrough is that we have found an EEG signature that appears to be a biomarker for the presence of disease in this mouse model of Huntington’s disease that can identify early changes in the brain prior to the onset of behavioral symptoms,” said Morairty, the paper’s senior author. “While the current study focused on Huntington’s disease, many neurodegenerative diseases produce changes in the EEG that are associated with the degenerative process. This is the first step in being able to use the EEG to predict both the presence and progression of neurodegenerative diseases.”

Although previous studies have shown there are distinct and extensive changes in EEG patterns in Alzheimer’s and Huntington’s disease patients, researchers are looking for changes that may occur decades before disease onset.

Huntington’s disease is an inherited disorder that causes certain nerve cells in the brain to die, resulting in motor dysfunction, cognitive decline and psychiatric symptoms. It is the only major neurodegenerative disease where the cause is known with certainty: a genetic mutation that produces a change in a protein that is toxic to neurons.

Study: Longitudinal Analysis of the Electroencephalogram and Sleep Phenotype in the R6/2 Mouse Model of Huntington’s Disease

Source: SRI International

Lilly Acquires Novel Tau Tangle Diagnostic Program to Bolster Alzheimer’s Disease Research and Development

Eli Lilly and Company (NYSE: LLY) recently announced it has acquired two investigational positron emission tomography (PET) tracers from Siemens Medical Solutions USA, Inc. The tracers are intended to image tau (or neurofibrillary) tangles in the brain, one of two known hallmarks of Alzheimer’s disease. Based on studies of samples obtained at autopsy, the amount and location of tau tangles in an Alzheimer’s disease patient’s brain is thought to correlate with the severity of the disease. There are currently no approved diagnostics to detect tau tangles in living patients, creating challenges for scientists working to understand the progression of the disease and how therapies may impact it.

Lilly will initially focus on incorporating this new technology into its anti-amyloid and anti-tau research and development (R&D) programs. Use of a tau tangle tracer could enable tailoring and early identification of at-risk patients, as well as potentially provide a marker for treatment response. Lilly also has the option to commercialize the tracers. The tracers will be developed and validated by a team at Avid Radiopharmaceuticals, Lilly’s wholly owned subsidiary focused on molecular imaging. Financial terms of the deal are not being disclosed.

“The acquisition of these tau tangle tracers builds on our 25-year commitment of investing in Alzheimer’s disease research and development to bring new medicines to patients facing the terrible consequences of Alzheimer’s disease,” said Jan M. Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. “We are hopeful that this technology will both enhance our understanding of tau and its role in Alzheimer’s disease, and contribute to the development of our anti-amyloid and anti-tau based therapies to treat this disease.”

“PET imaging is a valuable tool in the fight against Alzheimer’s disease, and Siemens is committed to helping fight this growing threat to our aging population,” said James Williams, CEO, Siemens Molecular Imaging business unit. “Lilly’s continued development of these tau PET tracers combined with Siemens’ ongoing investment in innovative PET imaging solutions is another great example of how Siemens is collaborating with pharmaceutical companies in an effort to provide new hope to patients and their families.”

There are two defining pathologies linked to the development of Alzheimer’s disease: the accumulation of amyloid-beta protein that forms beta-amyloid plaques outside of neurons, and the accumulation of tau protein that forms tau tangles inside them.The formation of tau tangles is thought to block the transport of nutrients and essential molecules throughout the cell, leading to neurodegeneration, or the progressive loss of structure or function of neurons. The formation of tau tangles mostly occurs after beta-amyloid plaques have developed, but unlike beta-amyloid plaques the evolution of tau tangle pathology is believed to closely mirror cognitive decline.

Scientists theorize that both beta-amyloid plaques and tau tangles are required for the development of Alzheimer’s disease, with the accumulation of amyloid beta representing the early trigger that initiates the disease process and tau tangles playing a secondary but critical role in the process of neuronal toxicity and death. For this reason, Lilly has established R&D programs to explore both the amyloid and tau hypotheses. Today’s acquisition will inform and help progress Lilly’s multiple approaches to treating Alzheimer’s disease, with the goal of speeding innovation to patients worldwide.

Source: Eli Lilly

Shiel Medical Laboratory’s Oxidized LDL Triple Marker Test Uncovers Symptoms of Latent Heart Disease Better than Standard Lipid Test

The primary clinical laboratory test used by physicians to identify patients with coronary artery disease (CAD) fails to measure oxidized low-density lipoprotein (LDL), the plaque-specific protein directly involved in the disease process. A key study demonstrated that nearly half the patients with documented coronary events had LDL cholesterol readings within healthy range, exposing a major weakness in the standard lipid panel and the need for measuring oxidized LDL levels.

Shiel Medical Laboratory’s Oxidized LDL Triple Marker Test is the only blood test that measures oxidized LDL, which reflects atherosclerotic disease activity in the arterial wall. As an identifier of clinical and subclinical CAD, the test is superior to any other laboratory test available to assess patient risk of cardiovascular disease, which kills 400,000 Americans annually and costs $110 billion in medical services and lost productivity.

“Research studies show measuring LDL cholesterol alone is insufficient to determine whether a patient is at risk for heart attack or stroke,” said Shiel Medical Laboratory Technical Services Director, Harold M. Bates, Ph.D., who was involved in the commercial development of the oxidized LDL test. “Oxidized LDL as a biomarker test could easily become the successor to the regular LDL test because of its greater clinical efficacy.”

Shiel’s Oxidized LDL Triple Marker Test overcomes the weaknesses of conventional lipid tests by measuring oxidized LDL, a plaque-specific protein. Oxidized LDL is the atherogenic form of LDL cholesterol linked to the deposition of plaque in the artery walls. The CAD disease process depends on the oxidation of LDL, making oxidized LDL the primary culprit molecule in cardiovascular disease.

In addition to oxidized LDL, the Oxidized LDL Triple Marker Test measures two additional biomarkers linked to CAD: HDL cholesterol, an anti-atherogenic substance that inhibits the disease-causing action of oxidized LDL; and high-sensitivity C-reactive protein (hs-CRP), an independent biomarker that at certain lower levels is associated with cardiovascular disease.

Like oxidized LDL, hs-CRP is not included in the standard lipid panel even though elevated oxidized LDL and chronically elevated hs-CRP may explain why half of all patients hospitalized with CAD have lipid readings that appear normal.(1)

In published medical studies assessing known and emerging lipid biomarkers, oxidized LDL measurements rendered the most accurate snapshot of CAD risk. A 2006 study of 921 subjects, including 490 CAD patients and 431 healthy individuals in the control group, compared the relative potency of oxidized LDL to LDL cholesterol in identifying patients with CAD.(2 )Oxidized LDL showed a six-fold ability over LDL cholesterol in indicating disease. Measuring the oxidized LDL/HDL ratio and adding hs-CRP levels to round out the Triple Marker profile produced a 16-fold ability over LDL cholesterol in identifying CAD disease.

“Every physician needs to know that standard lipid panels do not measure elevated oxidized LDL even in patients with low to moderate LDL. I’m certain more patients would request the Oxidized LDL test if they knew how much more effective it is in detecting CAD than the standard LDL test,” said Charles Mitgang, M.D., an internist in Rockville Centre, N.Y. “The test has become part of my routine in identifying, treating and monitoring patients who are at risk for CAD.”

Shiel Medical Laboratory is the first and only laboratory to develop the automated Oxidized LDL Test and establish reference ranges allowing physicians to better interpret results. Shiel introduced the test in 2006, following lab validation and approval by the New York State Department of Health. The laboratory exhibits annually at Scientific Sessions for the American Heart Association and the American College of Cardiology and researchers and clinicians have embraced this lipid biomarker test as a much-needed addition to the cardiac disease prevention arsenal.

Source: PR Newswire