MicroRNA Biomarkers in Cyst Fluid May Improve the Management of Pancreatic Cysts

Asuragen reports data from a study of microRNA biomarkers in pancreatic cyst fluid at the American Pancreatic Association Annual Meeting

Austin, Texas - November 3, 2011. Asuragen, Inc. announced today that data from a collaborative study with Johns Hopkins regarding microRNA biomarkers for use on pancreatic cyst fluid specimens was presented at the American Pancreatic Association Annual Meeting being held November 2-5, 2011 in Chicago.

Approximately 3% of the US population harbors an asymptomatic pancreatic cyst. Most of those cysts are benign and can be managed conservatively by watchful waiting. However, some, such as intraductal papillary mucinous neoplasms (IPMNs), represent precursors of pancreatic cancer. Patients with high grade (HG) dysplasia IPMN need to undergo immediate resection, as do patients with other, less common cyst entities, such as solid pseudopapillary neoplasms (SPNs) and cystic neuroendocrine tumors (NETs). Currently it is challenging to accurately identify the specific cyst entity and predict the grade of dysplasia without resection and precise histopathologic examination.

Asuragen, in collaboration with Anirban Maitra, M.D., of the Sol Goldman Pancreatic Cancer Research Center at Johns Hopkins University School of Medicine identified a 9-miRNA model that predicts a probability that a cyst is at risk for malignant transformation and therefore should be surgically removed. In a blinded validation study using 50 histologically confirmed pancreatic cyst fluid specimens, this 9-miRNA model showed a sensitivity of 89% and specificity of 100% in distinguishing low risk lesions (SCAs, LG IPMNs) from high risk lesions (HG IPMNs, NETs and SPNs). In addition, it stratified a group of intermediate grade (IG) IPMNs into the low and higher risk categories. This 9-miRNA signature will be validated in a larger study using prospectively collected EUS FNA specimens to establish its clinical application toward stratification of patients with pancreatic cysts for surgical intervention or watchful waiting.

About Asuragen

Asuragen is a fully integrated diagnostic development company and pharmaceutical services provider. The Company's diagnostic product portfolio consists of the first-ever validated microRNA diagnostic service for pancreatic cancer, quantitative RNA tests for leukemia gene translocations, innovative genetic testing solutions for the fragile X mental retardation (FMR1) gene, Signature® Oncology products for the qualitative detection of gene translocations and mutations in a variety of hematological and solid tumors, RNA stabilization technologies, and industry-leading controls and standards engineered using its patented Armored RNA® technology. Asuragen is empowered with a high level of scientific expertise and assay development capabilities, CLIA and GLP testing services, and an established cGMP manufacturing facility, which allow it to span the spectrum of discovery, testing, production and commercialization. For more information, visit www.asuragen.com.

Signature® and Armored RNA Quant® are registered trademarks of Asuragen, Inc.

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