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Archives for August 2013

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

Biomarkers Predict Time to Ovarian Cancer Recurrence

Ovarian cancer often remains undetected until it is at an advanced stage. Despite positive responses to initial treatment, many patients are at risk of tumor recurrence. A multitude of genetic markers have been implicated in ovarian cancer prognosis. However, the genetic testing required is not practical or affordable in a clinical setting.

In this issue of the Journal of Clinical Investigation, Roel Verchaak and colleagues at the MD Anderson Cancer Center identify protein biomarkers that are predictive for time of ovarian cancer recurrence and develop a PRotein-driven index of OVARian cancer (PROVAR).

Using PROVAR, the authors were able to discriminate between patients with high and low risk of cancer recurrence, as well as short-term and long-term survival prognosis. In combination with genetic diagnosis, analysis of protein biomarkers may be useful in predicting outcome and determining a treatment plan for ovarian cancer patients.

Study: Predicting time to ovarian carcinoma recurrence using protein markers [Journal of Clinical Investigation]

Source: EurekAlert!

MicroRNAs have Diagnostic and Prognostic Potential in Urinary Bladder Cancer

German researchers have identified four biomarkers that correctly determine malignancy of urinary bladder cancers and contribute to the accurate prediction of patient outcomes. Their results are published in the September issue of The Journal of Molecular Diagnostics.

Current prognosticators of bladder cancer, such as tumor grade, stage, size, and number of foci, have limited usefulness for clinicians since they do not accurately reflect clinical outcomes. Therefore, investigators have been searching for new biomarkers with better diagnostic and prognostic capabilities. Focusing on the role of microRNAs (miRNAs), small non-coding RNAs, researchers have identified four miRNAs that together perfectly discriminated between nonmalignant and malignant tissue, including one alone that classified 81% of the samples correctly. Levels of two miRNAs correlated with overall survival time.

Urinary bladder cancer is the fourth most common cancer in the West. According to the National Cancer Institute, it is estimated that in the United States 72,570 individuals will be diagnosed with and 15,210 will die of cancer of the urinary bladder in 2013. At presentation, in 75% of patients the cancers are confined to the mucosa or submucosa (known as non-muscle invasive bladder cancer, NMIBC), whereas in 25% of cases the cancers have already invaded nearby muscle (muscle-invasive bladder cancer, MIBC).

In a series of experiments, investigators analyzed bladder tissue from patients with NMIBC, MIBC, and nonmalignant bladders. After screening 723 miRNAs by microarray, they selected a subset of 15 distinctively deregulated miRNAs for further validation by real-time quantitative PCR. Seven miRNAs were found to be up-regulated, and eight were down-regulated in malignant bladder tissue samples compared to healthy tissue. Four miRNAs were expressed differently in bladder cancers that invaded muscle compared to those that did not. With one exception, no correlation was found between tumor stage and miRNA levels.

When all 15 of the selected miRNAs were considered together, they correctly classified 100% of tissues as either normal or malignant. Further analysis identified four miRNAs that led to 100% correct classification, and one miRNA (miR-130b) that by itself had an 81% accuracy rate. “These results underline the great potential of miRNAs to serve as diagnostic markers, as previously noted for other urological tumors,” says lead investigator Klaus Jung, MD, the Department of Urology at the University Hospital Charité, Berlin and the Berlin Institute for Urologic Research.

The investigators found that tumor grading could not be correlated with overall survival. Yet, they were able to find two miRNAs that significantly correlated with survival: miR-141 and miR-205. miR-141 showed a trend (P=0.08) of being able to stratify patients with muscle-invasive tumors into two groups with different overall survival times. “This finding could be of clinical importance, but these results must be interpreted cautiously,” says Dr. Jung. “However, previously published studies underline the possible prognostic potential of miRNAs to predict progression and disease-specific or overall survival in bladder cancer patients.”

miRNAs are small non-coding RNAs that contain between 19 and 24 nucleotides. miRNAs regulate gene expression by degrading messenger RNAs or impairing their translation. In recent years there has been a growing interest in miRNAs as potential diagnostic and/or prognostic biomarkers in cancers and other diseases.

Study: miRNA Profiling Identifies Candidate miRNAs for Bladder Cancer Diagnosis and Clinical Outcome [Journal of Molecular Diagnostics]

Source: Elsevier

Creighton Awarded $1.44 Million for Bench-to-Bedside Asthma Research

What started as basic cancer research at Creighton University has yielded promising results for diagnosing and treating asthma – and the National Institutes of Health (NIH) agrees, investing nearly $1.5 million in Creighton to find out more.

In a previous prostate cancer study, Yaping Tu, Ph.D., a cancer biologist and associate professor of pharmacology at Creighton University School of Medicine, studied a mouse model that was missing a specific gene, called RGS2; he believed the deleted gene would lead to prostate cancer in the animals. Though the tumors failed to develop, Tu noticed the mice had trouble breathing and were less active, similar to asthma patients. With the help of Creighton’s renowned allergy and asthma researcher Thomas Casale, M.D., professor of medicine and microbiology and immunology and Chief of the Division of Allergy and Immunology, Tu soon determined the animals suffered from airway hyperresponsiveness, or a twitchiness of the airways – a cardinal feature of asthma.

“This finding piqued our interest and made us wonder if there was a connection to human patients with asthma,” says Tu. “In a preliminary study funded by the American Asthma Foundation, we were able to confirm that RGS2 is downregulated in a high percentage of patients with asthma, confirming the possibility that this may be a target for a novel gene therapy in asthma patients.”
Now with a $1.44 million, four-year NIH grant, Tu and collaborators Casale and Peter Abel, Ph.D., professor of pharmacology at Creighton University School of Medicine, will take a bench-to-bedside approach to explore how the gene works in the development of airway hyperresponsiveness and whether it can be used as a diagnostic marker for asthma. Finally, the collaborators will work to develop a therapeutic approach to restore gene function, with the hope of one day applying the research to human trials.

Asthma currently affects more than 25 million Americans. There is not one cause; different patients have different triggers. The one shared trait, however, is airway hypperresponsiveness possibly related to the change to RGS2.

“Our current treatment options are similar to a lock-and-key,” Casale explains. “Each drug on the market is the key to unlock and treat a different symptom or pathway important in causing asthma – and we still haven’t found all of the keys. We still have a lot of work to do, but our findings suggest that therapy targeting RGS2 gene expression might just be the master key to managing a critical component of asthma as a whole.”

Research reported in this press release was supported by the National Heart, Lung and Blood Institute of the National Institutes of Health under award number R01HL116849. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Source: Creighton University

PerkinElmer Expands Prenatal Screening Test Offerings, Introducing First Early Onset Preeclampsia Screening Test in the U.S.

PerkinElmer, a global leader in human and environmental health and an innovator in the field of prenatal screening for more than thirty years, announced today the first available early onset preeclampsia screening test in the United States. The PreeclampsiaScreen™ | T1 serum screening test enables physicians to more precisely detect asymptomatic patients in the first trimester of pregnancy who are at high risk for developing the dangerous condition, allowing for earlier identification, management and intervention. Early onset preeclampsia is a potentially serious condition that affects 0.5% of all pregnancies, often contributing more to the pregnant mother’s and baby’s risks of morbidity and mortality than does the late form of the disorder.

“This first of its kind screen is our latest commitment to providing clinicians with new, innovative ways to address some of today’s most challenging prenatal clinical scenarios,” said Jim Corbett, Senior Vice President and President, Diagnostics and Life Sciences & Technology for PerkinElmer. “Together with our recent advances, including offering a non-invasive prenatal test based on cell-free fetal DNA, plus a wide range of prenatal testing from biochemical screening to SNP microarray testing to detect birth defects and chromosome abnormalities, we’re giving physicians effective new tools for patient management.”

According to Dr. Jiri Sonek, MD RDMS, President, Fetal Medicine Foundation USA, and Adjunct Professor, Department of Obstetrics and Gynecology from Wright State University, “Preeclampsia is one of the remaining great challenges in obstetrics. It is a major cause of maternal, fetal, and neonatal morbidity and mortality. Fortunately, some physicians may recommend a simple and inexpensive intervention to reduce the risk of preeclampsia which is available in the form of low-dose aspirin. However, this treatment is effective only if begun early in pregnancy. That is why first trimester screening is such a critical component of preeclampsia prevention.”

Early onset preeclampsia is defined as preeclampsia, a sudden increase in blood pressure and protein in the urine, which leads to delivery of the fetus prior to 34 weeks’ gestation. If found early, options such as increased monitoring, modified activity, bed rest and medication can help reduce or avoid complications related to early onset preeclampsia.

PreeclampsiaScreen™ | T1 is administered during the first trimester of pregnancy through a simple blood test to detect three biochemical markers in the mother’s blood: PAPP-A (pregnancy-associated plasma protein-A); PlGF (placental growth factor) and AFP (alpha fetoprotein) that, when evaluated collectively with personal demographic data, provide an individual risk of developing early onset preeclampsia. Physicians have the option to provide two additional biophysical measurements for their patients — mean arterial pressure (MAP) and uterine artery Doppler pulsatility index (UtAD-PI) – each increasing the sensitivity of the screen when included in the testing protocol.

Source: PerkinElmer