LUND, Sweden, March 24, 2025 /PRNewswire/ -- Immunovia (IMMNOV: Nasdaq Stockholm), the pancreatic cancer diagnostics company, today announced additional results from the successful VERIFI study of its next-generation pancreatic cancer test, strengthening the company's position as it prepares to launch the pancreatic cancer blood test commercially.
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.
"The Immunovia test accurately classified cancerous and non-cancerous blood samples in the VERIFI study," said 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:
Risk Group
Cases
Controls
Sensitivity
Specificity
Overall
317
1,134
78 %
92 %
Familial/Genetic
71
922
78 %
94 %
Diabetes
128
105
80 %
90 %
Cysts
79
426
72 %
89 %
"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," said Jeff Borcherding, CEO of Immunovia. "These data bolster our commercial opportunity and expand our addressable market."
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 (88% vs. 89%). In the VERIFI study, specificity was a secondary endpoint, not a co-primary endpoint, because the low number of control samples in the study (271) 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.
About the VERIFI Study
The VERIFI study was conducted using 385 blood samples from six leading pancreatic cancer centers in the U.S. Researchers analyzed 115 samples from patients with Stage I and II pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. These were compared to 270 control samples from people without pancreatic cancer classified as high risk. These high-risk individuals had a family history of pancreatic cancer, concerning genetic mutations, pancreatic cysts (fluid-filled sacs in the pancreas that sometimes develop into pancreatic cancer), or a combination of these risk factors.
About Pancreatic Cancer
Pancreatic cancer is one of the most aggressive cancers, with a five-year survival rate of just 13%. Early detection is critical for improving patient outcomes, particularly for individuals at high risk of pancreatic cancer. Individuals with certain genetic mutations or family history of PDAC face higher risk. Certain pancreatic cysts, such as intraductal papillary mucinous neoplasms (IPMNs), also pose a significant cancer risk, with up to 15% progressing to pancreatic cancer within 15 years.
Immunovia AB (IMMNOV: Nasdaq Stockholm), 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
