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BIDMC Cardiovascular Institute Researchers Will Lead $4 Million NIH Grant to Study MicroRNAs

A cardiovascular research team from Beth Israel Deaconess Medical Center (BIDMC) and Brigham and Women’s Hospital (BWH), led by BIDMC Principal Investigator Saumya Das, MD, PhD, has been awarded a $4 million Common Fund grant from the National Institutes of Health (NIH) as part of a newly formed program on Extracellular RNA Communication. The five-year grant will focus on identifying microRNA biomarkers in heart disease.

Each year, complications from heart attacks (myocardial infarctions) contribute to more than half a million cases of heart failure and 300,000 cases of sudden cardiac arrest, when the heart suddenly stops. Both of these conditions are closely related to a process known as remodeling, in which the structure and function of the heart changes – or remodels — following a heart attack.

“Our goal is to explore the role that microRNAs play in predicting which heart-attack patients will go on to experience complications,” explains Das, an electrophysiologist in BIDMC’s Cardiovascular Institute and co-director of the cardiovascular genetics program within the Outpatient Cardiovascular Clinic.

“Current strategies used to identify the highest risk patients have often been inaccurate,” he adds. “We think that a blood test that makes use of microRNA biomarkers could replace existing strategies and more accurately predict which patients might experience poor outcomes and thereby identify who would most benefit from frequent monitoring and medical care.” Other investigators who are part of the NIH grant, “Plasma miRNA Predictors of Adverse Mechanical and Electrical Remodeling After Myocardial Infarction,” include BIDMC Director of Cardiovascular Research Anthony Rosenzweig, MD, and BWH investigators Raymond Y. Kwong, MD, MPH, and Mark Sabatine, MD, MPH.

microRNAs are one type of extracellular RNA. Once considered nothing more than genomic “junk,” microRNAs have more recently been recognized as playing a key role in cellular functions. Several years ago, scientists began to recognize that these small, noncoding RNAs were not only found inside cells, but could also be found in blood and other tissue fluids.

Using patient plasma samples from extensively characterized patients who have suffered heart attacks, the scientific team will first identify which specific microRNAs are related to poor heart remodeling. They will then use cell culture and animal models of heart disease to further prioritize which microRNAs play a functional role in disease progression. Finally, the investigators will validate these prioritized microRNAs as prognostic markers for poor health outcomes after heart attacks in a large prospective clinical trial.

“Ultimately, we think that miRNA-based tests could replace current tests to predict which patients might be at risk of complications and, therefore, be good candidates to receive an implanted defibrillator,” says Das. “At the same time, we hope to be able to better predict which individuals are at less risk of complications – and thereby spare them unnecessary and costly procedures.”

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and currently ranks third in National Institutes of Health funding among independent hospitals nationwide.

BIDMC has a network of community partners that includes Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, Signature Health Care, Commonwealth Hematology-Oncology, Beth Israel Deaconess HealthCare, Community Care Alliance, and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Senior Life and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.org.

Source: Beth Israel Deaconess Medical Center

Exosome Diagnostics Enters Collaboration Agreement with Lilly for Exosome Blood-Based Biomarker Discovery

Exosome Diagnostics recently announced it has entered into a collaboration agreement with Eli Lilly and Company (NYSE: LLY) for biomarker discovery and validation using Exosome Diagnostics proprietary EXO50 nucleic acid extraction kit. Under the agreement, Lilly will gain early access to Exosome Diagnostics technology to help identify key gene mutations and expression levels in blood that may be correlated with drug response and disease recurrence. Financial terms were not disclosed.

“Exosome Diagnostics technology may provide a unique opportunity to gain insight into the biology of complex conditions such as cancer and immune disorders,” said Andrew Schade, senior medical director, diagnostic and experimental pathology at Lilly. “Exosome technology enables biofluid molecular sampling and the ability to monitor disease progression in real time. As Lilly explores new ways to pursue patient tailoring, we’ll continue to work with partners to expand our capabilities.”

“Accessing high quality messenger and microRNA directly from frozen patient fluid samples offers a rapid, cost-effective route to identify and validate biomarkers, which may be correlated with drug response and disease recurrence,” said James McCullough, chief executive officer of Exosome Diagnostics. “Lilly has accumulated an extensive and well annotated clinical blood sample biobank that provides a unique opportunity to track target biomarkers through the clinical trial process and help overcome the limitations of stored biopsy tissue.”

Exosomes and other microvesicles are secreted by all cells into all biofluids, and provide a natural biological packaging and distribution mechanism for RNA and DNA. Exosome Diagnostics’ rapid exosome isolation and extraction technology produces high-quality RNA and DNA, including full length mRNA and microRNA, from small volumes of patient biofluids, such as blood (serum and plasma), urine and cerebrospinal fluid, for analysis by standard PCR, array and sequencing instruments. Analysis can be performed on fresh or frozen fluid samples, allowing for broad, flexible and convenient analyses of clinical trial samples, both in real-time and retrospectively, with no special preservation methods required. Exosomes and their protected nucleic acid contents are being investigated in a broad range of diseases including cancer, CNS disorders such as Alzheimer’s and Parkinson’s disease, cardiovascular disease, maternal/fetal medicine, and chronic kidney disease, among others. In July, QIAGEN and Exosome Diagnostics signed an agreement for the creation of High-Performance Biofluid Sample Preparation Kits for Personalized Healthcare Research which covers the exclusive supply of these products upon availability in 2014.

Source: Exosome Diagnostics

NanoString Technologies Receives FDA 510(k) Clearance for Prosigna Breast Cancer Prognostic Gene Signature Assay

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Prosigna™ Breast Cancer Prognostic Gene Signature Assay. Based on the PAM50 gene signature, Prosigna is the company’s first FDA-cleared in vitro diagnostic assay and uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay is performed using the nCounter® Dx Analysis System, which can be placed in qualified laboratories throughout the United States, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients.

“Receipt of FDA 510(k) clearance for Prosigna marks a key milestone for NanoString and is an important step forward in the treatment of breast cancer. This achievement is a testament to the ongoing dedication and professionalism of our team, and the commitment of our collaborators,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “Prosigna illustrates our approach of using nCounter technology to translate genomic discoveries into powerful in vitro diagnostic products, and it represents a significant growth opportunity beyond our robust life sciences research business.”

The Prosigna Assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years, and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive (one to three positive nodes) hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. For each patient, the Prosigna Assay reports the Prosigna Score (referred to as Risk of Recurrence Score, or ROR Score, in the scientific literature, including the TransATAC study recently published in the Journal of Clinical Oncology ) and a risk category based on both the Prosigna Score and nodal status. Node-negative patients are classified as low, intermediate or high risk, while node-positive patients are classified as low or high risk.

Other key features of the Prosigna Breast Cancer Prognostic Gene Signature Assay include:

  • All-in-one assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue
  • High-throughput workflow allowing each nCounter Dx Analysis System to process up to 30 patient samples per eight hour work day
  • Automated generation of personalized full-color patient reports that can be quickly and easily shared electronically with ordering oncologists

Bruce Seeley, Senior Vice President & General Manager of Diagnostics of NanoString Technologies commented: “We believe that the compelling clinical data, clear patient reporting, and unique delivery model position Prosigna for success in the U.S. market. By integrating the Prosigna Assay into existing laboratory workflows, we are offering physicians and patients seamless and timely access to clinical insights and a powerful tool that can aid in making more informed treatment decisions.”

Prosigna-enabled nCounter Dx Analysis Systems are expected to be available for placement in high-complexity Clinical Laboratory Improvement Amendments (CLIA) certified laboratories late in the fourth quarter of 2013. Prosigna testing services are expected to be available through qualified U.S. clinical laboratories beginning in the first quarter of 2014.

Source: NanoString Technologies

New Workflow to Provide Scientists with Tools That Enable Single Cell Analysis for Oncology, Immunology and Stem Cell Research

NanoString Technologies, Inc. (NASDAQ: NSTG), a provider of life science tools for translational research and molecular diagnostic products, and BD Biosciences, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, recently announced a collaboration agreement for the development of a single cell isolation and analysis workflow.

Under the agreement, the companies will jointly develop a workflow using the NanoString nCounter®Analysis System (including the nCounter Single Cell Assay) and the BD Flow Cytometry cell sorter product line (emphasizing the new BD FACSJazz™ Cell Sorting System). The combined workflow will enable single cell gene expression analysis for research applications such as oncology, immunology and stem cell research. Collaboration activities will also include the development of materials documenting the workflow protocol, as well as co-hosting meetings and webinars to educate scientists about the single cell workflow.

“Maximizing both the quantity and quality of data that can be extracted from a single cell is critical to the emerging field of single cell biology. The nCounter Analysis System can analyze entire gene pathways and provides a highly precise and reproducible digital output, making it ideally suited to the task,” said Brad Gray, President and Chief Executive Officer, NanoString Technologies. “The nCounter Analysis System and the BD FACSJazz Cell Sorting System can together provide a powerful and efficient workflow for single cell gene expression analysis.”

“Our collaboration with NanoString Technologies furthers BD’s commitment to providing researchers advanced solutions for cell analysis and isolation,” said Alberto Mas, President, BD Biosciences. “We believe this new sorting workflow will complement the recent and very rapid advances in genomic studies that value the requirement for greater sample integrity for critical single cell analysis.”

NanoString Technologies’ nCounter Analysis System is a multi-application digital detection and counting system with a highly automated and simple workflow. The company’s Single Cell Gene Expression application provides researchers with a highly flexible and sensitive approach to discovering differences in cell-to-cell gene expression profiles.The application enables up to 800 genes to be detected in a single tube.

The BD FACSJazz Cell Sorting System is capable of identifying, characterizing and isolating single or multiple cells – from complex or extremely rare cell populations – and depositing them in 96 and 384 well plates to provide rapid cell isolation, tracking and identification throughout the process.

For more information about NanoString Technologies, the nCounter Analysis System and the nCounter Single Cell Assay, please visit www.nanostring.com.

For more information on the BD FACSJazz Cell Sorting System, please visit www.bdbiosciences.com/facsjazz.

Source: BD Biosciences

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