The article, "Validation of a serum-based biomarker signature for detection of early-stage pancreatic ductal adenocarcinoma," presents results from VERIFI, the second independent validation of Immunovia's PancreaSure test. The study demonstrates that PancreaSure has the ability to detect Stage I and II pancreatic cancer in high-risk individuals with 76.5% sensitivity and 87.8% specificity.

"Our results confirm that PancreaSure can reliably distinguish early-stage pancreatic cancer from high-risk controls," said Norma Palma PhD, VP Clinical and Medical Affairs at Immunovia. "This secondary validation study adds to the body of evidence of the test’s strong performance in early detection of pancreatic cancer. Data from this study also helps us understand the potential role of the PancreaSure test in early detection of cancer in patients with pancreatic cysts.”

The design of the VERIFI study largely mirrored that of the CLARITI study, the first clinical validation of the PancreaSure test. In VERIFI, strict age and gender-matching of case and control samples was performed to provide a clear evaluation of test performance.

Importantly, the VERIFI study included 145 patients with pancreatic cysts, including 62 individuals whose only risk factor for pancreatic cancer was the presence of one or more cysts. These individuals represent a particularly challenging group for clinicians and the VERIFI study builds on prior data indicating the accuracy of the PancreaSure test in patients with cysts.

"The publication in Current Oncology provides important independent validation of PancreaSure's performance," said Jeff Borcherding, CEO of Immunovia. "With two successful validation studies now published in peer-reviewed journals, we have established a strong foundation of scientific evidence supporting PancreaSure's role in early pancreatic cancer detection for high-risk populations."