In the study of over 1,000 patient samples, the test achieved the primary endpoint, exceeding the predefined accuracy criteria and marking a critical milestone in Immunovia’s mission to increase patient survival through early detection of pancreatic cancer, states the company.

“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,” says Jeff Borcherding, CEO and President of Immunovia. “We are deeply grateful to the pancreatic cancer experts and clinical leaders who partnered with us on this large, rigorous, and challenging study. These compelling results position Immunovia as a leader in the early-detection market and bring us closer to fulfilling our mission of improving pancreatic cancer survival worldwide.”

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The CLARITI study

The CLARITI study utilized blood samples from 18 of the world’s leading pancreatic cancer centers, representing the largest reported clinical validation study for a pancreatic cancer blood test in a high-risk patient population. Among the 1,066 samples analyzed, 202 were from patients with stage 1 and 2 pancreatic cancer. The remaining 864 were control samples from individuals at high risk for pancreatic cancer, primarily due to family history or genetics. Using high-risk controls in CLARITI made it a more rigorous and challenging assessment of test accuracy, unlike many other validation studies that use blood samples from healthy, low-risk controls. All CLARITI study samples were obtained from patients other than those used in prior development studies.

Remains on track

Based on the results, Immunovia remains on track to introduce its next-generation test to the U.S. market in the second half of 2025.

In parallel, Immunovia will also conduct additional clinical studies to assess the test’s accuracy, clinical impact and economic value across different high-risk patient groups. The studies will continue throughout 2025 and will support regulatory submissions and efforts to secure test reimbursement.