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Meso Scale Discovery Launches V-PLEXTM Multiplex Biomarker Immunoassays

Meso Scale Discovery, a division of Meso Scale Diagnostics, LLC. (MSD®), recently announced the global launch of its V-PLEX biomarker tests, a new line of fully validated immunoassays for clinical research.

Study Identifies Fibroblast Growth Factor 18 as an Ovarian Cancer Biomarker

Ovarian cancer is one of the leading causes of cancer-related death in women and is often not detected until the later stages of disease, which contributes to poor prognosis. Biomarkers that can be used for early diagnosis and outcome have been identified; however, many of these have not been evaluated at the biological and clinical levels. In the current issue of the Journal of Clinical Investigation, Michael Birrer and colleagues at Massachusetts General Hospital identify fibroblast growth factor 18 (FGF18) as a predictive marker for poor overall survival in ovarian cancer patients. Overexpression of the gene encoding FGF18 was associated with enhanced tumor blood vessel formation and expression of cancer promoting cytokines. These data indicate that further studies on the predictive potential FGF18 and its use as a therapeutic target in ovarian cancer are warranted.

Study: FGF18 as a prognostic and therapeutic biomarker in ovarian cancer [The Journal of Clinical Investigation]

Source: EurekAlert!

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

First Test to Objectively Diagnose Fibromyalgia Now Available

A recent peer-reviewed study, published in BMC Clinical Pathology,[1] reveals a medical breakthrough discovering multiple biomarkers based upon highly sensitive and reproducible medical investigations. Conducted by the University of Illinois College of Medicine at Chicago (UIC) and EpicGenetics, a privately-held biomedical company, the research has led to the development of The FM/a® Test (www.thefmtest.com), the first test to objectively diagnose fibromyalgia.

Researchers at the UIC Department of Pathology conducted a statistically significant study involving more than 200 patients, comparing those clinically diagnosed with fibromyalgia to healthy patients. The study revealed that patients with fibromyalgia have a dysregulation disorder affecting protein molecules called chemokines and cytokines, produced by white blood cells. While fibromyalgia patients have been classified to be hyperactive (or overactive) responders, the study showed that people with fibromyalgia have immune production patterns which may make them more vulnerable to stress, thereby leading to chronic pain, severe fatigue, diffuse muscle tenderness, insomnia, and other unbearable symptoms long associated with fibromyalgia. Evaluation of The FM Test patient results will provide a continuing database that could lead to further insight into what may cause and exacerbate fibromyalgia and permit the development of standards to determine effective treatments.

EpicGenetics worked with fibromyalgia support groups to recruit participants in the clinical research study and is collaborating with groups such as the National Fibromyalgia & Chronic Pain Association to educate the fibromyalgia community and others about the availability of The FM Test.

“The results of our research have allowed us to ‘pull back the curtain’ and identify specific diagnostic biomarkers in fibromyalgia,” said Bruce S. Gillis, MD, MPH, member of the clinical faculty at the UIC College of Medicine and founder of EpicGenetics. “For decades, the medical community has viewed fibromyalgia with much skepticism. Patients have been stigmatized, and many are spending thousands of dollars and years of frustration in search of a diagnosis. Our breakthrough provides patients with hope and validation that their symptoms are real, and we hope physicians who commonly see patients with fibromyalgia will embrace and value this test for its role in the advancement of medical care.”

According to the American College of Rheumatology, fibromyalgia affects more than 12.3 million people in the United States, comparable to the number of people affected by cancer. Patients who experience symptoms, such as chronic pain and fatigue, depression and insomnia, spend an average of three to five painful years seeking a diagnosis and $4,800-$9,300 annually on associated medical costs. Until now, there has been no conclusive test to confirm the diagnosis of fibromyalgia.

The FM Test, a simple blood test with more than 93 percent sensitivity, now makes it possible for anyone to find out if they have fibromyalgia. The FM Test costs $744 with conclusive results available to most patients usually in a week or less – a fraction of the time and money the average patient currently spends seeking a diagnosis.

By completing a simple symptoms questionnaire at www.thefmtest.com, patients and their doctors can find out if they qualify for the test. If a patient meets the requirements, they can arrange for the test at their doctor’s office or at an independent blood draw facility.

“The elegantly designed study by Dr. Gillis and his co-investigators represents a milestone on the path our group charted 25 years ago when we first hypothesized that cytokines play a role in fibromyalgia2. It is hoped that this and future work sponsored by EpicGenetics will lead to a greater understanding of how the immune system, fatigue, sleep disorders, chronic stress and pain interact in patients with fibromyalgia and related disorders,” said Daniel J. Wallace MD, FACP, FACR, a clinical professor of medicine at the David Geffen School of Medicine at UCLA based at Cedars-Sinai Medical Center, and a member of the Scientific Advisory Board of EpicGenetics.

Source: Business Wire

New Evidence for Link Between Depression and Heart Disease

A Loyola University Medical Center psychiatrist is proposing a new subspecialty to diagnose and treat patients who suffer both depression and heart disease. He’s calling it “Psychocardiology.”

In his most recent study, Angelos Halaris, MD, PhD, and colleagues found that an inflammatory biomarker, interleukin-6, was significantly higher in the blood of 48 patients diagnosed with major depression than it was in 20 healthy controls. Interleukin-6 has been associated with cardiovascular disease. Halaris presented findings at a joint congress of the World Psychiatric Association and International Neuropsychiatric Association in Athens, Greece. At the congress, Halaris formally proposed creation of a new Psychocardiology subspecialty.

Forty to 60 percent of heart disease patients suffer clinical depression and 30 to 50 percent of patients who suffer clinical depression are at risk of developing cardiovascular disease, Halaris said.

Stress is the key to understanding the association between depression and heart disease. Stress can lead to depression, and depression, in turn, can become stressful.

The body’s immune system fights stress as it would fight a disease or infection. In response to stress, the immune system produces proteins called cytokines, including interleukin-6. Initially, this inflammatory response protects against stress. But over time, a chronic inflammatory response can lead to arteriosclerosis (hardening of the arteries) and cardiovascular disease.

It’s a vicious cycle: depression triggers a chronic inflammation, which leads to heart disease, which causes depression, which leads to more heart disease.

Clinical depression typically begins in young adults. “Treating depression expertly and vigorously in young age can help prevent cardiovascular disease later on,” Halaris said.

Physicians often work in isolation, with psychiatrists treating depression, and cardiologists treating cardiovascular disease. Halaris is proposing that psychiatrists and cardiologists work together in a multidisciplinary Psychocardiology subspecialty.

A Psychocardiology subspecialty would raise awareness among physicians and the public. It would forge closer working relationships between psychiatrists and cardiologists. It would formalize multidisciplinary teams with the requisite training and expertise to enable early detection of cardiovascular disease risk in psychiatric patients and psychiatric problems in heart disease patients. And it would provide continuing education to physicians in the safe and correct use of medications in cardiac patients who have psychiatric disorders.

“It is only through the cohesive interaction of such multidisciplinary teams that we can succeed in unravelling the complex relationships among mental stress, inflammation, immune responses and depression, cardiovascular disease and stroke,” Halaris said.

Source: EurekAlert!