The case-control study will evaluate the accuracy of the Immunovia test in detecting Stage 1 and 2 pancreatic cancer in blood samples collected from approximately 150 CDKN2A patients in Leiden, home to a disproportionately high number of people who carry the mutation.

Leiden University Medical Center (LUMC) operates an extensive pancreatic cancer surveillance and research program for CDKN2A mutation carriers, seeing more than 300 patients annually. LUMC has collected blood samples from these patients for several years, creating an incredibly unique and valuable biobank for research.

“Individuals with the CDKN2A mutation face a terribly high risk of pancreatic cancer. We must improve early detection for these patients,” said Prof. Monique van Leerdam, Professor of Gastroenterology and Hepatology at Leiden University Medical Center. “The CLARITI and VERIFI studies demonstrated that the PancreaSure test is highly accurate in detecting Stage 1 and 2 pancreatic cancer in high-risk individuals. We are eager to evaluate the test’s performance in our CDKN2A patients.”

“The Leiden group is world renowned for its research in pancreatic cancer, particularly in those with CDKN2A mutations,” said Jeff Borcherding, Immunovia CEO. “We are honored Prof. van Leerdam and her team chose PancreaSure. This study is a significant opportunity to expand our clinical evidence to support reimbursement and regulatory submissions.”

Immunovia is preparing for a commercial launch of the PancreaSure test in the U.S. market in September 2025. The company will conduct additional studies to assess the test’s clinical impact and further evaluate its accuracy in other high-risk populations to support regulatory submissions and payer reimbursement efforts. Immunovia is also engaging potential commercial partners to accelerate market adoption.