Immunovia’s next-generation test detected significantly more cancers than CA19-9, a common biomarker for pancreatic cancer, in the study, the company states. 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.

“The Immunovia test accurately classified cancerous and non-cancerous blood samples in the VERIFI study,” says Jeff Borcherding, CEO of Immunovia. “The test once again significantly outperformed CA19-9. In addition, combined results from the CLARITI and VERIFI studies make it clear that our next-generation test can accurately detect pancreatic cancer in multiple different groups of high-risk individuals.”

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:

“The combined test performance data from CLARIFI and VERIFI represents a key milestone for Immunovia: demonstrating excellent test accuracy across multiple groups of high-risk patient groups for the first time,” says Borcherding. “These data bolster our commercial opportunity and expand our addressable market.”