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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

Harmony Prenatal Test Now Being Offered in Mexico for Safe and Timely Risk Assessment of Chromosome Conditions During Pregnancy

Ariosa Diagnostics announced the offering of its Harmony™ Prenatal Test in Mexico through a partnership with Advance Medical on August 22, making the Latin American nation with over 2 million live births one of 46 countries around the world where the Harmony Prenatal Test can be ordered by healthcare providers. The Harmony test enables clinicians throughout Mexico to offer a non-invasive, early, reliable blood test to pregnant women. The Harmony test is both safe and cost effective, providing a personalized risk assessment for chromosome conditions such as Down syndrome.

The Harmony test has an accuracy rate above 99% for evaluation of fetal trisomy 21 risk, and a false positive rate of 0.1%, which is 50 times lower than conventional serum screening, translating into fewer referrals to unnecessary invasive diagnostic procedures such as amniocentesis that carry the inherent risk of miscarriage.

According to Dr. Dora Gilda Mayen Molina, Medical Genetic Specialist at the Hospital Angeles Lomas and Hospital Angeles Mexico, “The Harmony Prenatal Test can be performed for women with pregnancies of at least 10 weeks gestational age, and it is available for any singleton or twin pregnancy, including all those conceived by IVF.”

A recent study published in the American Journal of Obstetrics and Gynecology provided new evidence that non-invasive prenatal testing, specifically the Harmony test, is effective for screening in the general population. In the study of more than 2,000 women undergoing routine screening for fetal trisomies, the Harmony Prenatal Test accurately assessed the risk of all cases of fetal trisomy 21 and 18, with a false positive rate of 0.1 percent.

According to Dr. Thomas Musci, vice president of clinical and medical affairs for Ariosa Diagnostics, this partnership will “allow us to bring the highest quality and most clinically validated prenatal test to patients in Mexico for the betterment of prenatal medicine. We are very pleased to have partnered with Advance Medical.”

Source: PR Newswire

Mount Sinai and Exosome Diagnostics Partner to Accelerate Translation of Body Fluid Molecular Diagnostics to Overcome Limitations of Tissue Biopsy in Areas of Critical Unmet Medical Needs

The Icahn School of Medicine at Mount Sinai and Exosome Diagnostics today announced a collaboration on the research and development of real-time nucleic acid-based body-fluid diagnostics to advance personalized medicine. Exosome will provide technical and development support to Mount Sinai researchers along with early access to proprietary technology products upgrades. The agreement will allow Exosome and Mount Sinai to establish targeted research and biomarker discovery programs in oncology, inflammation and other disease areas. Exosome anticipates pursuing commercial development and FDA review of successful validations for in vitro diagnostics.

“This collaboration represents the model that research centers and private companies need to adopt in the post-recession, sequestered economy to develop diagnostic products that can improve clinical outcomes, help advance drug development programs and help lower healthcare costs,” said James McCullough, Chief Executive Officer of Exosome Diagnostics. “New York State has taken an aggressive and appropriate approach to promoting cooperation of its leading research centers, such as Mount Sinai, with private industry resources and commercial capability to drive translational medicine. Mount Sinai and Exosome together can accelerate cutting-edge diagnostic products to serve the clinical market.”

Carlos Cordon-Cardo, MD, PhD, Chair, Department of Pathology, Icahn School of Medicine at Mount Sinai, added, “As we advance our precise medicine program in the Departments of Pathology and Genomics at Mount Sinai, biofluid-based, point-in-time analyses, made possible by the Exosome Diagnostics-Mount Sinai relationship, will undoubtedly lead to an improved, patient-centric understanding of disease, thereby guiding more informed treatment decisions and response to therapy.”

The agreement was negotiated by Mount Sinai Innovation Partners (Mount Sinai IP), which encourages the commercialization of novel research conducted at the Icahn School of Medicine at Mount Sinai. Mount Sinai plans to leverage the considerable expertise of its clinical investigators in areas of key unmet medical needs to develop clinical study programs taking advantage of Exosome’s unique technology that has the ability to extract high-quality RNA from blood, urine and cerebrospinal fluid.

Under the agreement, Mount Sinai will retain rights to molecular biomarkers associated with disease progression and drug response, and Exosome will retain commercial development rights for molecular in vitro diagnostic products. The collaboration will extend for five years. Dr. Cordon-Cardo receives financial compensation from Exosome Diagnostics as a member of its scientific advisory board.

Source: PR Newswire

Quest Diagnostics Introduces Comprehensive Opioid Therapy Genetic Test Based on CYP450 Biomarker License with Transgenomic

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, recently announced the availability of a new lab-developed genetic test to aid the delivery of personalized opioid pain-relieving treatment. It is believed to be the first clinical lab to offer testing for variants in all cytochrome P450 (CYP450) genes known to influence the CYP450 enzyme system, which affects metabolism of opioids and other medications.

ImmusanT Initiates Study at Joslin Diabetes Center to Investigate Relationship Between Celiac Disease and Type 1 Diabetes

ImmusanT recently announced that it has initiated a clinical research study to explore the immunologic relationship between celiac disease and Type 1 diabetes (T1D) and to further understand the underlying cause of T1D. The research will focus on characterizing immune responses in patients affected by both T1D and celiac disease. The study will be performed by the Joslin Diabetes Center.

It is estimated that celiac disease affects about one in 100 Americans, but in people with T1D about one in 10 are affected by the disease. Celiac disease is caused by an immune response to dietary gluten, but the trigger for the immune response causing T1D is not as clear. Studies suggest that genes putting people at risk of T1D and celiac disease are the same, and shared by several other common autoimmune diseases. Further research into whether the immune response causing celiac disease is related to the autoimmune response causing T1D may reveal new information about autoimmune disease in general.

The study with Joslin will assess patients with celiac disease only and patients who have both celiac disease and T1D. The goal of the study is to compare biomarker response in both sets of patients, which may elucidate drivers of T1D. In the long-term, this study could provide insights into potential treatments for T1D.

“Type 1 diabetes and celiac disease appear to be closely related, so it is natural that the next disease that ImmusanT would examine is T1D,” noted Bob Anderson, Chief Scientific Officer of ImmusanT and the inventor of Nexvax2®. “By better understanding the mechanisms that are common to T1D and celiac disease, we may be able to leverage our expertise gained from developing Nexvax2 to identify a way to halt or prevent the autoimmune response in patients with Type 1 diabetes.”

“ImmusanT pioneered the development of the only antigen-specific immunotherapeutic approach to celiac disease and we are eager to broaden our knowledge with others to uncover mechanisms common to other immune diseases,” commented Leslie Williams, President and Chief Executive Officer of ImmusanT.

Source: PR Newswire