Immunovia provides further data from VERIFI study of pancreatic cancer test

Immunovia (IMMVF) announced additional results from the VERIFI study of its next-generation pancreatic cancer test. Immunovia’s next-generation test detected significantly more cancers than CA19-9, a common biomarker for pancreatic cancer, in the study. The company also announced that the specificity of its test in the VERIFI study was equivalent to CA19-9 and just below the target specificity for the trial. VERIFI met the primary study endpoint. On March 19 2025, Immunovia announced the VERIFI study met its primary endpoint, with the test successfully detecting 77% of stage I and II pancreatic cancer cases, far exceeding the target of 65%. This sensitivity was significantly better than the sensitivity of CA19-9, which was 69%. Combined data showed strong accuracy across multiple high-risk patient groups. Combined data from the VERIFI and CLARITI validation studies allow for robust analysis of test performance across patient groups at high risk for different reasons. The Immunovia next-generation test demonstrated excellent and consistent sensitivity and specificity across key high-risk groups, including those at risk due to family history of pancreatic cancer or genetic mutations, patients with diabetes, and people with pancreatic cysts. Specificity in the VERIFI study was in line with target performance and CA19-9. The specificity of the Immunovia test was 88%, compared to the target specificity of 90%. Like the previous CLARITI study, the specificity of the Immunovia test was essentially equal to the specificity of CA19-9. In the VERIFI study, specificity was a secondary endpoint, not a co-primary endpoint, because the low number of control samples in the study made the quantification of specificity less precise. VERIFI results strengthen and support Immunovia’s commercial plans. Immunovia is actively preparing to launch its next-generation test in the third quarter of 2025. The company will conduct additional clinical studies throughout the year to assess the test’s clinical impact and further evaluate its accuracy in other high-risk populations. These studies will support regulatory submissions and payer reimbursement efforts. Immunovia is also engaging potential commercial partners to accelerate market adoption.