Asuragen introduces miRInform test for diagnosis of pancreatic ductal adenocarcinoma

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.

“We believe miRNAs will prove to be highly relevant for many additional cancer diagnostic applications.”

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® Pancreas Test 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."