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Researchers Discover Biomarker, Potential Targeted Therapy for Pancreatic Cancer

University of Cincinnati (UC) researchers have discovered a biomarker, known as phosphatidylserine (PS), for pancreatic cancer that could be effectively targeted, creating a potential therapy for a condition that has a small survival rate.

Study Says New Biomarker May Predict Mesothelioma Survival, According to Surviving Mesothelioma

A team of researchers at Australia’s University of New South Wales say MUC1, a glycoprotein found on the outer surface of epithelial cells, is overexpressed in peritoneal mesothelioma. MUC1 is a mucin, a type of protein that helps protect the body against infection by binding with pathogens in the extracellular space and preventing them from entering cells.

Although MUC1 overexpression can predict poor survival in most cancers, and is often used to help diagnose mesothelioma, the Australian study is the first to measure its prognostic significance in mesothelioma, a rare cancer brought on by asbestos exposure. Mesothelioma most often occurs on the membrane that lines the lungs but peritoneal mesothelioma affects the lining of the abdomen. It accounts for about 25 to 30 percent of mesothelioma cases and, like all types of mesothelioma, is usually deadly.

Of the 42 peritoneal mesothelioma patients in the new study, 38 showed overexpression of MUC1. The significance of that overexpression was measured using the Kaplan-Meier method. Mesothelioma patients with a MUC1 level (based on immunohistochemical tests) between 5 and 8 had the lowest survival in all subtypes of tumors. Of the different variables tested – including tumor subtype, patient gender, peritoneal cancer index, and age at diagnosis – only a high MUC1 level and being over 60 years old at the time of diagnosis were consistently associated with poor outcomes.

Writing on their findings in the International Journal of Biological Markers, the authors conclude, “MUC1 evaluation by immunohistochemistry may serve as a useful prognostic tool in malignant peritoneal mesothelioma, but may need further confirmation in larger patients’ cohort.” Earlier this year, the same team of researchers determined that high expression of BCL2, a protein that helps regulate cell death (apoptosis), is associated with a good prognosis for patients with peritoneal mesothelioma.

In clinical practice, biomarkers are often used to help plan a treatment strategy for mesothelioma and other hard-to-treat cancers.

The original study appears in a recent issue of the International Journal of Biological Markers. (Pillai, K, et al, “MUC1 has prognostic significance in malignant peritoneal mesothelioma”, July 4, 2013, International Journal of Biological Markers, Epub head of print. http://www.ncbi.nlm.nih.gov/pubmed/23828409)

Study: MUC1 has prognostic significance in malignant peritoneal mesothelioma [International Journal of Biological Markers]

Source: PR Web

Biomarker Predicts Heart Attack Risk Based on Response to Aspirin Therapy

Aspirin has been widely used for more than 50 years as a common, inexpensive blood thinner for patients with heart disease and stroke, but doctors have little understanding of how it works and why some people benefit and others don’t.

Now researchers at Duke Medicine have solved some of the mysteries related to the use of this century-old drug, and developed a blood-based test of gene activity that has been shown to accurately identify who will respond to the therapy.

The new gene expression profile not only measures the effectiveness of aspirin, but also serves as a strong predictor of patients who are at risk for heart attack, according to a study appearing July 3, 2013, in the online edition of the Journal of the American College of Cardiology.

“We recognized the concept of aspirin resistance among a population of patients who have cardiac events or stroke,” said senior author Geoffrey S. Ginsburg, M.D., PhD, director of genomic medicine at Duke’s Institute for Genome Sciences & Policy and executive director of the Center for Personalized Medicine. “We give the same dose to all patients, but maybe some patients need a larger dose of aspirin, or maybe they need to try a different therapy entirely. We need better tools to monitor patients and adjust their care accordingly, and the findings from our study move us in that direction.”

The Duke researchers enlisted three groups of participants – two of healthy volunteers and one comprised of patients with heart disease seen in outpatient cardiology practices.

The healthy volunteers were given a dosage of 325 mg of aspirin daily for up to a month; the heart disease patients had been prescribed a low dose of aspirin as part of their treatment. Blood was then analyzed for the impact of aspirin on RNA expression and the function of platelets, which are the blood cells involved in clotting.

The RNA microarray profiling after aspirin administration revealed a set of 60 co-expressed genes that the researchers call the “aspirin response signature,” which consistently correlated with an insufficient platelet response to aspirin therapy among the healthy subjects as well as the heart disease patients.

The researchers also examined the aspirin response signature in another group of patients who had undergone cardiac catheterizations. They found the signature was also effective in identifying those patients who eventually suffered a heart attack or died.

“The aspirin response signature can determine who is at risk for heart attack and death,” said Deepak Voora, M.D., assistant professor of medicine at Duke and lead author of the study. “There is something about the biology of platelets that determines how well we respond to aspirin and we can now capture that with a genomic signature in blood.”

Ginsburg said the research is progressing to recreate the findings in other populations, and to develop a standardized testing system that could one day move the analysis into daily practice.

“Nearly 60 million people take aspirin regularly to reduce their chances of heart attack and death, but it doesn’t work for everyone,” said Rochelle Long, Ph.D., of the National Institutes of Health’s National Institute of General Medical Sciences, which partly supported the study. “By monitoring gene activity patterns these investigators uncovered a ‘signature’ linked to inadequate responsiveness. This work may eventually lead to a simple blood test to identify those who do not benefit from aspirin, enabling them to seek other therapeutic options.”

In addition to Ginsburg and Voora, study authors include Derek Cyr; Joseph Lucas; Jen-Tsan Chi; Jennifer Dungan; Timothy A. McCaffrey; Richard Katz; L. Kristin Newby; William E. Kraus; Richard C. Becker; and Thomas L. Ortel.

The study received funding from the Duke Institute for Genome Sciences & Policy; the National Institutes of Health (T32HL007101 to DV); the National Center for Research Resources (UL1RR024128); the National Institutes of General Medical Sciences (RC1GM091083); the Centers for Disease Control and Prevention (5U01DD000014); and the David H. Murdock Research Institute.

Study: Aspirin Exposure Reveals Novel Genes Associated with Platelet Function and Cardiovascular Events

Source: Duke Medicine

JAMA Pediatrics Study Highlights Cancer Risk Associated with CT Scans

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, protein biomarker-based assay for identifying patients at low risk for appendicitis, today announced its support of key findings from a large retrospective study that was published earlier this week in the peer-reviewed medical journal JAMA Pediatrics. The study concluded, among other things, that the risk of radiation-induced solid cancers was highest for patients undergoing CT scans of the abdomen/pelvis and that abdominal/pelvic scans saw the most dramatic increase in use over the study period, especially among older children. Possible appendicitis was cited as a leading cause of abdominal/pelvic CT usage.

Importantly, the authors of the study concluded that reducing unnecessary CT scans in favor of other imaging or non-imaging approaches (if proven through research to be as effective), combined with effective radiation dose-reduction strategies, could dramatically reduce the number of radiation-induced cancers.

Steve Lundy, President and CEO of Venaxis, stated, “The findings of this large observational study are aligned with our focus – developing a blood-based APPY1 Test to aid physicians in identifying patients at low risk for acute appendicitis. We applaud the authors of the study for reporting these findings and for highlighting the urgent need for research to determine when the use of CT scans leads to improved health outcomes and when other imaging and non-imaging diagnostic techniques could be as effective. The APPY1 Test is designed to provide rapid, objective results and has demonstrated high negative predictive value for appendicitis in clinical studies. Venaxis’ goal with the APPY1 Test is to provide physicians with an additional tool that may allow for more conservative patient management, including reducing the number of CT scans.”

The JAMA Pediatrics study measured the rate of CT scan use (from 1996 to 2010) and the dose of ionizing radiation (for CT scans performed between 2001 and 2011) in children younger than 15 years of age, and estimated the lifetime attributable risks of certain cancers. The projected lifetime attributable risk of developing solid cancers was higher for patients who underwent CT scans of the abdomen/pelvis or spine than for patients who underwent other types of CT scans. The risk was highest for younger patients and for girls, with a radiation-induced solid cancer projected to result from every 300 to 390 abdomen/pelvis scans.

Study: The Use of Computed Tomography in Pediatrics and the Associated Radiation Exposure and Estimated Cancer Risk

Source: Venaxis

No Biomarkers Identified to Assess Potential Health Effects of GMOs

Many people in Europe are critical of genetically modified (GM) food, due to safety concerns. A Eurobarometer survey, published in 2010, revealed that the European public tends to be worried on a “mediate level” about GM food, with people in Austria being particularly concerned. Today, genetically modified maize is cultivated commercially, mainly in Spain and Portugal. Nonetheless, authorised GM Organisms (GMO) may enter the European market as feed for animals or in food products.

Whether such products pose any health threats to consumers, is controversial. “We have to find the best way to evaluate the issue,” says Michelle Epstein, an allergy and immunology clinician from the Medical University of Vienna, Austria. She coordinated a recently completed EU-funded project called GMSAFOOD that aimed at identifying possible biomarkers for indicating adverse health effects of GM food. Such biomarkers could be used for monitoring commercially available GM food or feed.

The European Food Safety Authority EFSA, who plays a fundamental role in assessing the risk of GM crops and derived food and feed in Europe, has included a recommendation for so-called post-market monitoring (PMM) in its Guidance for risk assessment of food and feed from genetically modified plants, published in 2011. This approach is supposed to complement the pre-market toxicological tests. “This [the PMM] is for the unexpected things”, Epstein explains. “Even if you do a lot of testing before placing a product on the market, it is not the public at large you are testing,” she tells youris.com. Some people may have immune diseases or consume certain products at very high levels.

As part of the project, the researchers conducted feeding experiments with pigs, mice, salmon and rats. They fed them with a variety of commercially available GM maize, called MON 810, and a pea containing a pest resistance gene derived from a bean. “We were using the peas because we knew it had effects”, Epstein says. Indeed, a previous study published in 2005 by Australian scientists had shown allergenic responses in mice feeding on the pea.

However, the researchers were not successful in their search for biomarkers. “We didn’t see any health effects”, Epstein comments. Moreover, when looking at the allergenic effect the peas had caused in the original study, the scientists found the same effects in the native bean, implying that the GM pea did not cause the allergic reaction. They attributed this discrepancy to a cross-reaction with a substance called pea lectin and to technical differences between testing laboratories.

The project scientists also developed a machine learning approach to identify potential GMO-associated biomarkers. Data is fed into a mathematical model, which is supposed to find parameters that may serve as biomarkers. “We proposed to the [European Commission] to set up a public repository with all of the project data,” Epstein says. This public database would also allow people from research and industry to include their own data and use the approach for identifying biomarkers for PMM.

Experts doubt the usefulness of PMM, in this case. “In my view, in contrast to the mandatory post-market environmental monitoring, monitoring GM food is questionable,” comments Joachim Schiemann, biosafety expert at the Julius Kühn-Institut, Federal Research Centre for Cultivated Plants, Germany. He considers the pre-market risk assessment of GM food as sufficient in most cases. He argues that uncertainties should be defined prior to introducing a product to the market. “The regulatory authorities have to decide how much uncertainty is acceptable,” Schiemann adds.

Other experts agree. “I am personally very reluctant to consider PMM as a useful tool for risk management of GM food or feed,” Harry Kuiper, retired scientist at Wageningen University, the Netherlands, and former head of the GMO Panel at EFSA, says. He points at various difficulties PMM may face. For example, he believes that it is hard to determine which group to target and how much of a product people actually consume.

“For the GM foods on the market today, there are simply no indications for identification of biomarkers upon exposure of humans or animals,” Kuiper also tells youris.com. “Personally, I would try to solve problems or uncertainties identified with GM food or feed during the pre-market risk assessment”, he adds. However, he believes that future GM food, which may alter the physiological or nutritional status of humans or animals, may provide opportunities for identifying biomarkers.

While she is not opposed to post-market monitoring, Helen Wallace, director of the not-for-profit organisation Genewatch UK recognises that “it is a very hard thing to do”. Instead, “we need more pre-market assessments of GM crops”, Wallace says. In her view, these should include follow-ups of studies, which suggest possible adverse health effects. She also criticises prevalent study designs and the fact that regulators have to rely on commercial studies: “These lack independence and often data isn’t made public by companies.”

Source: Youris.com