Company claims that if the device can be used with FNA biopsies, diagnosis will be less invasive.
Asuragen is teaming up with a number of academic research centers to develop an miRNA-based test that will help diagnose pancreatic cancer from fine-needle aspirate (FNA) biopsies. The institutes involved in this arrangement are The University of Pittsburgh Medical Center, Brigham and Women’s Hospital, H. Lee Moffitt Cancer Center, Dartmouth’s Hitchcock Medical Center, and the University of Sherbrooke.
The collaborating sites will provide clinical expertise and samples so that Asuragen can evalaute the clinical utility of its miRNA test to distinguish pancreatic adenocardinoma from chronic pancreatitis and other noncancerous disorders.
Asuragen’s miRNA test currently uses formalin-fixed biopsy or resection specimens to help resolve cases for which standard cytopathology has been inconclusive. The company claims if the test can be validated for FNA biopsies, patient samples could be obtained less invasively, and it may negate the need for surgery.
Asuragen offers a range of capabilities for molecular diagnostics and services, from identifying and validating novel mRNA and miRNA biomarkers to developing and manufacturing new assays under specific regulatory requirements. The company emerged from what was left of RNA company Ambion in 2005/2006. Ambion sold off its research products division to Applied Biosystems Group and formed Asuragen with about 100 employees from its diagnostics and molecular biology services divisions.
Asuragen established its CLIA lab in Austin in 2007/2008 and launched the first miRNA-based diagnostic test for distinguishing pancreatic cancer from chronic pancreatitis. In December 2007, the decision was made to move the miRNA therapeutics activities into a new entity call Mirna Therapeutics. Mirna was seeded with $3M from Asuragen and is actively developing oncology candidates.
In November 2009, Asuragen signed an exclusive agreement with Life Technologies for worldwide distribution of an in vitro diagnostic test to aid in the monitoring and treatment of patients with chronic myeloid leukemia. As part of the agreement, Asuragen will pursue CE marked-IVD registration in Europe and regulatory clearance in the U.S. The diagnostic test will then be distributed by Life Technologies and will run exclusively on the Applied Biosystems 7500 Fast Dx real-time PCR instrument.
In October 2009, Asuragen won over $3.8 million in new grant funding from the SBIR, STTR, and American Recovery and Reinvestment Act initiatives of the NIH. The grants will be used to fund research and product development in the fields of oncology and genetic disease.