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PancreaSure™ Demonstrates 88% Sensitivity and 98% Specificity in Interim Analysis of Third Validation Study

LUND - Immunovia AB (publ.), the pancreatic cancer diagnostics company, today announced results from a large international validation study, AFFIRM, demonstrating the accuracy of the PancreaSure pancreatic cancer test in Stage 3-4 disease. In the study, PancreaSure detected cancer in 88.1% of blood samples from people with Stage 3 and 4 pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. The PancreaSure test accurately classified 97.7% of samples from healthy individuals without cancer.

“The PancreaSure test has now demonstrated excellent accuracy in three independent clinical studies,” said Jeff Borcherding, CEO of Immunovia. “PancreaSure is intended to detect early-stage pancreatic cancer in those at high risk for the disease, and the test showed strong performance in this target group in both the CLARITI and VERIFI studies. The AFFIRM study builds on these findings, reassuring physicians that PancreaSure can also detect late-stage disease and perform very well in healthy individuals.”

The AFFIRM study includes samples from six sites across Europe and the United States. Results released today represent an interim analysis of the study. Immunovia plans to expand the study with approximately 180 additional samples, with final results to be announced in the fourth quarter of 2025.

Separately, Immunovia is conducting studies to understand the impact of the PancreaSure test on physician decisions when screening high-risk individuals for pancreatic cancer. These decision-impact studies are an important component of the Company’s pursuit of reimbursement of the PancreaSure test by government payers and private insurers in the US.

For further information, please contact
Jeff Borcherding, CEO
jeff.borcherding@immunovia.com

Immunovia in brief
Immunovia AB is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer. Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.
 
USA is the world’s largest market for detection of pancreatic cancer. The Company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing.
 
Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm.
For more information, please visit www.immunovia.com.

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PancreaSure™ Demonstrates 88% Sensitivity and 98% Specificity in Interim Analysis of Third Validation Study

Datum 2025-09-24, kl 14:00
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PancreaSure™ Demonstrates 88% Sensitivity and 98% Specificity in Interim Analysis of Third Validation Study
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