The data represent the first evaluation of PancreaSure in symptomatic individuals at elevated risk of pancreatic cancer. A pooled analysis across two validation studies shows that PancreaSure detected Stage I and II pancreatic ductal adenocarcinoma in genetically or familial high-risk individuals with symptoms of pancreatic cancer with 83.3% sensitivity and 91.6% specificity. Performance was consistent across clinically important sub-groups, supporting the test’s usability in its intended-use population.

The results are based on pooled data from Immunovia’s previously reported CLARITI and VERIFI validation studies, which included individuals at high risk of pancreatic ductal adenocarcinoma (PDAC) due to a genetic mutation (PGV) and/or a family history of pancreatic cancer. The current analysis was restricted to symptomatic individuals, including those with pancreatic cysts, diabetes, pancreatic abnormalities, pancreatitis, unexplained weight loss and other signs of pancreatic cancer.

PancreaSure detected Stage I and II PDAC with 83.3% sensitivity and 91.6% specificity in the high-risk symptomatic study population, consistent with the test’s performance in high-risk asymptomatic individuals in previous validations. Performance was consistent across symptomatic sub-groups and in individuals over 65 years of age – the population covered by Medicare insurance.

Because Medicare generally requires the presence of signs and/or symptoms to cover diagnostic testing, the high-risk symptomatic cohort represents the intended-use population for Immunovia’s planned submission to Medicare for a Local Coverage Determination (LCD) for PancreaSure.

“We are delighted to share these new and strong performance data for PancreaSure, which will support our upcoming application for Medicare coverage. By showing consistent performance across non-symptomatic and symptomatic individuals, these results provide further evidence of PancreaSure’s potential to improve patient survival by enabling earlier detection of pancreatic cancer in the high-risk surveillance populations on which we are focused,” says Jeff Borcherding, CEO and President, Immunovia.