Asuragen, Inc., a leader in molecular diagnostics and RNA-based
pharmacogenomics services, announced today that it has entered into
research agreements with The University of Pittsburgh Medical Center,
Brigham and Women’s Hospital, the H. Lee Moffitt Cancer Center,
Dartmouth’s Hitchcock Medical Center and the University of Sherbrooke to
develop a microRNA-based diagnostic test to aid the detection of
pancreatic cancer from fine-needle aspirate (FNA) biopsies.
“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”
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:
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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
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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)
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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.)
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Gregory Tsongalis, MHS, PhD, Director of Molecular Pathology,
Dartmouth Hitchcock Medical Center (Lebanon, N.H.)
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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.