Asuragen has launched the miRInform pancreas test to aid clinicians in the diagnosis and management of pancreatic ductal adenocarcinoma (PDAC) when cytology is inconclusive.
The pancreatic test measures expression levels of seven miRNAs in fine needle aspirate (FNA) specimens of pancreatic masses.
A study conducted by Asuragen and physicians from eight institutions across the US, Canada and Poland validated the 7-miRNA signature in blinded FNAs collected from over 180 patients with solid pancreatic masses.
The study showed that the pancreas test was able to accurately determine 75% of the FNAs that were indeterminate by cytology, which included around 13% of the samples in the study.
The miRInform also detected 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 demonstrated an overall accuracy of over 77% and a positive predictive value (PPV) of 86.5%.
The miRInform test combined with positive FNA cytology resulted in an overall accuracy of 92.5%. Overall sensitivity and specificity were 94.3% and 82.8%, respectively, with a PPV of 96.7%.
The study results demonstrate the value of the miRInform pancreas assay in treating indeterminate cases and reducing false negatives resulting from FNA cytology, simultaneously improving the diagnosis of PDAC.
Asuragen CEO Matt Winkler said the development and commercialisation of miRInform for FNA specimens capitalises on the company's molecular expertise and unsurpassed foundation in using miRNAs for diagnostic and therapeutic applications.
"We believe miRNAs will prove to be highly relevant for many additional cancer diagnostic applications," Winkler added.
Asuragen is a fully integrated molecular diagnostic company and pharmaceutical services provider, 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.
The company's product portfolio includes the first-ever validated microRNA diagnostic test for pancreatic cancer, multiplex quantitative RNA-based assays, solutions for the detection of the fragile X mental retardation gene (FMR1), Signature Oncology products for the qualitative detection of gene translocations and mutations, and cGMP RNA tissue stabilisation based upon RNALater technology.