Asuragen enters into research agreements to develop microRNA-based diagnostic test

The collaborative sites will provide clinical expertise and samples to help Asuragen evaluate the clinical utility of a microRNA (miRNA) test based on FNA biopsies to distinguish pancreatic adenocarcinoma from chronic pancreatitis and other non-cancerous conditions. These studies will be used to expand Asuragen’s current pancreatic cancer test program. The Company introduced the world’s first miRNA-based diagnostic test in 2008, which aids in the diagnosis of pancreatic cancer in formalin-fixed specimens. The FNA-based pancreatic cancer test is expected to be made available in Asuragen’s CLIA laboratory in the second half of 2010.

Dr. David Whitcomb, Chief of the Division of Gastroenterology, Hepatology, and Nutrition at the University of Pittsburgh Medical Center, said, “We are happy to be working with Asuragen on the development of tests to improve the diagnosis of pancreatic cancer. More accurate diagnosis of pancreatic adenocarcinoma using FNA samples will improve the clinical decisions in cases of suspected pancreatic cancer and help improve the management of patients for which conventional cytopathology is indeterminate.”

Dr. Darwin Conwell, Associate Professor of Medicine at Brigham and Women’s Hospital, said, “The recent data using miRNA in pancreas cancer is promising. We are pleased to participate in this multi-center study to enhance the diagnosis of pancreas cancer using recent advances in molecular biology. It is our hope that this study will clarify the diagnosis and help direct treatment strategies of our patients.”

“We are pleased to have research partnerships with many of the key scientific and clinical thought leaders in the field of pancreatic cancer and look forward to the participation of additional sites,” said Matt Winkler, PhD, Chief Executive Officer and Chief Science Officer of Asuragen. “These clinical alliances place Asuragen at the cutting edge of pancreatic cancer molecular diagnostics and support the Company’s goal to be a leader in the discovery and development of diagnostic products to improve the lives of cancer patients.”

Collaborating scientists and institutions include:

• Michael Sanders, MD, Assistant Professor; Randall Brand, MD, Visiting Professor of Medicine; and David Whitcomb, MD, PhD, Giant Eagle Professor of Cancer Genetics, Professor of Medicine, Cell Biology & Physiology, and Human Genetics, and Chief, Division of Gastroenterology, Hepatology and Nutrition, The University of Pittsburgh and the University of Pittsburgh Medical Center
• Darwin Conwell, MD, Associate Professor of Medicine, and Linda S. Lee, MD, EUS Endoscopist and Medical Director of Women’s GI Health, Center for Pancreatic Disease, Brigham and Women’s Hospital (Boston)
• Shivakumar Vignesh, MD, Associate Professor of Oncologic Sciences; Mokenge P. Malafa, MD, FACS, Chair, Department of Gastrointestinal Oncology and Program Leader GI Tumor Program; Jason Klapman, MD, Assistant Professor Oncological Sciences; James Barthel, MD, FACP, FACG, FASGE, Section Head Endoscopic Oncology; Barbara Centeno, MD, Senior Member, Anatomic Pathology and Professor, Department of Oncologic Sciences; H. Lee Moffitt Cancer Center (Tampa, Fla.)
• Gregory Tsongalis, MHS, PhD, Director of Molecular Pathology, Dartmouth Hitchcock Medical Center (Lebanon, N.H.)
• Jean Morisset, PhD, Associate Professor, George Rateb, MD, Assistant Professor; Charles Menard, BPharm, MD, Department of Gastroenterology, University of Sherbrooke, (Quebec, Canada).

Pancreatic ductal adenocarcinoma is the most prevalent form of pancreatic cancer and one of the most deadly cancers. Survival rates are low due to the lack of early detection and the lack of effective therapies. Asuragen’s miRNA test currently uses formalin-fixed biopsy or resection specimens and detects miRNAs that can distinguish pancreatic cancer from benign chronic pancreatitis. This FFPE-based test is intended to provide valuable information to physicians to resolve cases for which standard cytopathology results are inconclusive, which can often occur in pancreatic diseases. These research collaborations will help Asuragen evaluate the potential clinical utility and diagnostic performance of miRNAs for diagnosing pancreatic cancer using FNA biopsies, which can be obtained less invasively and may allow patients to avoid unnecessary surgery.