News Release

TGen-Asuragen partner to advance pancreatic cancer research

New microRNA technology agreement could lead to early disease detection

Business Announcement

The Translational Genomics Research Institute

PHOENIX, Ariz. — April 16, 2010 — The Translational Genomics Research Institute (TGen) and Asuragen Inc. today announced a research agreement that could lead to ways of detecting cancer before it spreads.

TGen's Dr. Glen Weiss, an Associate Investigator in TGen's Cancer and Cell Biology Division, plans initially to work with Asuragen to search for new ways of screening patients for pancreatic cancer, one of the fastest moving and deadliest types of cancer.

The project will combine the microRNA expertise and diagnostic development experience of Asuragen with TGen's strengths in basic and clinical research.

TGen moved to partner with Asuragen on this project because of its reputation as an excellent assay development partner, demonstrated market success and research compatibility with Dr. Weiss' work with microRNA technology.

Currently, there is no screening test in common use for pancreatic cancer, which in the U.S. is the fourth leading cause of cancer death, annually killing more than 35,000. Also, there is no diagnostic test, other than examining diseased tissue. As a result, pancreatic cancer often is not detected until the cancer is in advanced stages, when patients face diminishing treatment options.

"If we can identify among higher-risk individuals a potential biomarker that suggests additional investigation is warranted, such as a imaging, that has potential value —particularly if it leads to earlier detection and catching the cancer in an early stage," said Dr. Weiss, who also is director of Thoracic Oncology at TGen Clinical Research Services at Scottsdale Healthcare (TCRS).

TCRS is a partnership between TGen and Scottsdale Healthcare that enables laboratory discoveries to be quickly turned into targeted therapies that can be tested with patients at the Virginia G. Piper Cancer Center in Scottsdale.

"If you can use a blood test to identify metastatic pancreatic cancer before it shows up on imaging tests, we may prevent unnecessary surgery or invasive procedures,'' Dr. Weiss said. "In addition, our collaboration will seek to identify better prognostic indicators for predicting the course of the disease and the prospects for recovery."

Austin-based Asuragen is a leader in the development and use of microRNA technology to help find biomarkers that can pinpoint the genetic origins of disease. MicroRNAs are small molecules that regulate gene expression in the process of making proteins as well as directing the structure and function of cells. This regulation usually prevents cancer and other diseases.

Asuragen's focus on diagnostics for pancreatic cancer includes the development of its Pancreatic Adenocarcinoma Test, which was the world's first microRNA-based diagnostic test. This CLIA-based test is intended as an aid-in-diagnosis of pancreatic ductal adenocarcinoma (PDAC) versus chronic pancreatitis in resected pancreatic specimens. Asuragen is currently conducting a multi-institution study to develop a miRNA-based test for PDAC using fine needle aspirate specimens.

"This project to develop a blood-based, miRNA test for pancreatic cancer is a natural extension of Asuragen's pancreatic cancer projects and represents an exciting step forward in the effort to improve diagnosis and treatment of this deadly form of cancer," said Matt Winkler, CEO and CSO of Asuragen. "Asuragen recognized the value of blood-based miRNA markers very early and has been working steadily to enable early detection of cancer in circulating biofluids using miRNAs. We see great potential for this to transform screening and diagnosis of pancreatic cancer and ultimately the survival of pancreatic cancer patients."

The only current prognostic in pancreatic cancer is a blood test for tumor markers known as CA-19-9. "If we can identify biomarkers that improve on the performance of CA-19-9 as a prognostic test for disease relapse after surgery, that may be helpful in identifying those higher-risk individuals for new therapies that may prevent disease relapse," Dr. Weiss said.

TGen and Asuragen will work with blood samples collected from healthy individuals, those with pancreas abnormalities, and pancreatic cancer from collections developed through TGen's Pancreatic Cancer Biospecimens Repository, which is directed by Dr. Michael Demeure, a TGen Senior Investigator and endocrine surgeon. Other pancreatic cancer samples will come from a collection developed by the Pancreatic Cancer Research Team (PCRT), an international collaboration of pancreatic cancer investigators led, in part, by TGen.

"We are excited that our collection might help lead to earlier detection of pancreatic cancer and may lead to new prognostic biomarkers for this disease," said Dr. Demeure.

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About Asuragen Inc.

Asuragen is a fully integrated diagnostic development company and provider of molecular services, clinical laboratory and companion diagnostics services. Asuragen is currently leveraging its CLIA laboratory to offer and further commercialize the first ever laboratory developed microRNA diagnostic assay, designed to aid in the diagnosis and disease management of pancreatic ductal adenocarcinoma. Asuragen also manufactures and markets its Signature® Oncology and Genetic diagnostic kits for use in other clinical laboratories. Asuragen's Services Division provides comprehensive outsourcing solutions to aid in drug development, molecular biology research, and companion diagnostic test development. The cGLP laboratory services include sample preparation know-how, genomic profiling applications, biomarker discovery capabilities, assay design and validation, CLIA-based clinical testing, bioinformatic analysis, a high level of regulatory proficiency, and project management expertise. Asuragen has a proven track record in providing these services to major pharmaceutical and biotechnology companies, as well as academic institutions worldwide. In addition, Asuragen has a cGMP manufacturing facility that allows it to span the spectrum of discovery, testing, production, and commercialization. Visit our website at www.asuragen.com.

Press Contact:
Bernard Andruss, PhD
Director of Collaborations and Business Development
(512) 681-5246
bandruss@asuragen.com

About TGen

The Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. TGen is affiliated with the Van Andel Research Institute in Grand Rapids, Michigan. For more information, visit: www.tgen.org.

Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
syozwiak@tgen.org


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