Asuragen launches miRInform® Pancreas Test for Use on Fine Needle Aspirate Specimens of Pancreatic Masses
Austin, Texas – February 17, 2012. Asuragen, Inc. announced today the immediate availability of the miRInform® Pancreas Test in its CAP-accredited CLIA Laboratory. miRInform® Pancreas was developed to aid physicians in the diagnosis and management of pancreatic ductal adenocarcinoma (PDAC) when cytology is inconclusive. The test evaluates expression levels of seven miRNAs in Fine Needle Aspirate (FNA) specimens of pancreatic masses.
Over the last two years Asuragen and leading pancreatic physicians from the University of Pittsburgh Medical Center, Brigham Women’s Hospital, Moffitt Cancer Center, Dartmouth Medical School and the University of Sherbrooke, Canada, as well as the Silesian Medical University, the Hospital of the Ministry of Internal Affairs, and the Medical University of Łódź in Poland, have validated the 7-miRNA signature in blinded FNAs collected from over 180 patients with solid pancreatic masses. The study showed that the miRInform® Pancreas Test was able to accurately resolve over 75% of the FNAs that were indeterminate by cytology which comprised approximately 13% of the samples in the study. In addition, miRInform® identified more than half of the PDAC samples within the 30% false negative samples resulting from cytology alone. For samples determined by cytology to be benign or indeterminate, the test had an overall accuracy of over 77% and a positive predictive value (PPV) of 86.5%. The miRInform® PancreasTest combined with positive FNA cytology resulted in an overall accuracy of 92.5% versus 80.6% for cytology alone. The overall sensitivity and specificity were 94.3% and 82.8%, respectively, with a PPV of 96.7%. These results demonstrate the value of the miRInform® Pancreas Test in resolving indeterminate cases and reducing false negatives resulting from FNA cytology, which promises to improve the diagnosis of PDAC and permit the selection of the most appropriate treatment for these patients.
“The development and commercialization of miRInform® Pancreas for FNA specimens represents another breakthrough for Asuragen and capitalizes on our deep molecular expertise and unsurpassed foundation in using miRNAs for diagnostic and therapeutic applications,” commented Matt Winkler, Ph.D., CEO. “We believe miRNAs will prove to be highly relevant for many additional cancer diagnostic applications.”
Visit Asuragen’s website at www.asuragen.com to learn more about miRInform® Pancreas Test. To order please call 1-877-772-8018 or email ClinicalLabSupport@asuragen.com
Asuragen is a fully integrated molecular diagnostic company and pharmaceutical services provider. Asuragen is empowered with a high level of expertise from its Ambion heritage to provide science driven solutions for novel assay development, CLIA and GLP testing services, which, combined with established cGMP manufacturing capabilities, allow it to span the spectrum of discovery, production and commercialization for novel personalized tests and companion diagnostics. The Company’s product portfolio consists of the first-ever validated microRNA diagnostic test for pancreatic cancer, multiplex quantitative RNA-based assays, break-through solutions for the detection of the fragile X mental retardation gene (FMR1), Signature® Oncology products for the qualitative detection of gene translocations and mutations, cGMP RNA tissue stabilization based upon RNALater® technology, and industryleading controls and standards engineered using its patented Armored RNA® technology. In addition, Asuragen offers a full range of contract manufacturing services for high quality QSR compliant reagents from plasmid DNA to in vitro synthesized RNA and complex assays for IVD cleared platforms. Asuragen is dedicated to developing new technologies that will become cutting edge clinical products.
More information is available at the Company’s website: www.asuragen.com.
Sr. VP, CLIA and Pharmacogenomic Services
2150 Woodward St., Suite 100
Austin, TX 78744