Immunovia's Next-Generation Test: A Game Changer in Pancreatic Cancer Detection

Immunovia AB, a leading pancreatic cancer diagnostics company, has announced positive outcomes and strong accuracy in the clinical validation of its next-generation test for pancreatic cancer. This breakthrough test, designed to detect early-stage pancreatic ductal adenocarcinoma (PDAC), has shown remarkable results in a large-scale clinical validation study, positioning it as a potential game-changer in the fight against pancreatic cancer.

The CLARITI study, which involved over 1,000 patient samples from 18 leading pancreatic cancer centers worldwide, demonstrated the test's exceptional accuracy. The next-generation test achieved a sensitivity of 78% and specificity of 94% in detecting stage 1 and 2 PDAC. In patients aged 65 and older, the test's sensitivity improved to 80%, with specificity maintained at 91%. These results highlight the test's superior performance compared to CA19-9, the current gold standard for pancreatic cancer detection, which has a sensitivity of 64% and specificity of 91%.



Immunovia's next-generation test also outperformed CA19-9 in terms of early detection, with equal accuracy in detecting both stage 1 and stage 2 pancreatic cancers. Furthermore, the test's performance was higher in blood samples collected within the last five years, with sensitivity of 82% and specificity of 95%. This improvement suggests that the test's accuracy could be even greater when used clinically on fresh blood samples.

The CLARITI study utilized blood samples from high-risk patients, making it a more rigorous and challenging assessment of test accuracy. All samples were obtained from patients other than those used in prior development studies, ensuring the test's robustness and reliability.

Immunovia's CEO and President, Jeff Borcherding, expressed his enthusiasm about the test's potential impact on pancreatic cancer survival. He stated, "This marks a pivotal milestone for Immunovia in our quest to transform the pancreatic cancer landscape. Our next-generation test clearly has the accuracy to address the critical need for early detection."

The company remains on track to introduce its next-generation test to the U.S. market in the second half of 2025. In parallel, Immunovia will conduct additional clinical studies to assess the test's accuracy, clinical impact, and economic value across different high-risk patient groups. These studies will support regulatory submissions and efforts to secure test reimbursement.

In conclusion, Immunovia's next-generation test for pancreatic cancer has shown remarkable accuracy and early detection capabilities in a large-scale clinical validation study. With its superior performance compared to CA19-9 and the potential to improve patient outcomes, this test holds great promise in the fight against pancreatic cancer. As Immunovia continues to validate and refine its test, it could become a standard component of pancreatic cancer surveillance, contributing to improved patient survival and economic savings in the healthcare system.