Immunovia provides further positive data from the VERIFI study of its next-generation pancreatic cancer test

Rhea-AI Summary

Immunovia has announced additional positive results from its VERIFI study for its next-generation pancreatic cancer blood test. The test demonstrated 77% sensitivity in detecting stage I and II pancreatic cancer, exceeding the target of 65% and outperforming the CA19-9 biomarker's 69% sensitivity.

The test showed 88% specificity, slightly below the 90% target but comparable to CA19-9's 89%. Combined data from VERIFI and CLARITI validation studies demonstrated consistent accuracy across various high-risk groups, including individuals with family history, genetic mutations, diabetes, and pancreatic cysts.

The company plans to launch the test commercially in Q3 2025, with additional clinical studies planned throughout the year to support regulatory submissions and payer reimbursement efforts. Immunovia is also seeking commercial partners to accelerate market adoption.

Positive

• Test achieved 77% sensitivity in detecting early-stage pancreatic cancer, surpassing 65% target
• Outperformed existing CA19-9 biomarker (69% sensitivity)
• Demonstrated consistent accuracy across multiple high-risk patient groups
• Commercial launch planned for Q3 2025

Negative

• 88% specificity fell short of 90% target
• control sample size (271) affected specificity precision
• Additional clinical studies still required for regulatory approval

Insights

Financial Analyst

Immunovia's latest VERIFI study results represent a significant clinical milestone with promising commercial implications. The next-generation pancreatic cancer test demonstrated 77% sensitivity for early-stage pancreatic cancer detection, substantially exceeding the 65% target and outperforming the standard CA19-9 biomarker.

This performance differential creates a compelling value proposition for market adoption, particularly within the high-risk patient segments where early detection dramatically impacts survival rates. The consistent performance across diverse high-risk groups (those with family history, genetic mutations, diabetes, and pancreatic cysts) meaningfully expands Immunovia's addressable market beyond what was previously validated.

The Q3 2025 commercial launch timeline provides a clear catalyst for near-term value creation. However, investors should recognize that additional clinical studies, regulatory submissions, and payer reimbursement negotiations represent critical execution milestones before revenue materialization. The company's engagement with commercial partners signals strategic recognition that distribution partnerships may accelerate market penetration and potentially improve capital efficiency.

While specificity at 88% versus the 90% target represents a minor shortfall, this is unlikely to significantly impact commercial viability given the test's superior sensitivity and comparable specificity to existing standards. For a diagnostic targeting a deadly cancer with poor early detection rates, sensitivity often carries greater clinical and commercial weight than marginal specificity differences.

Oncology Specialist

The VERIFI study results demonstrate meaningful clinical progress in pancreatic cancer diagnostics. Detecting 77% of Stage I/II pancreatic cancers substantially outperforms the 69% sensitivity of CA19-9, the current standard biomarker. This 8 percentage point improvement in early detection capability is clinically significant for a cancer where five-year survival rates remain dismally low (11% across all stages, 42% when localized).

The consistent performance across diverse high-risk populations is particularly noteworthy. Current screening protocols struggle with heterogeneous risk factors, so a single test showing robust detection across familial risk, genetic mutation carriers, diabetic patients, and those with pancreatic cysts addresses a critical clinical need. The 88% specificity, while slightly below the targeted 90%, remains clinically acceptable, especially given equivalent performance to CA19-9.

The test's potential clinical utility depends on its integration into screening protocols for high-risk individuals. Immunovia's planned additional studies will be crucial for determining optimal testing intervals and clinical decision pathways. The Q3 2025 commercial timeline appears realistic given the completed validation studies, though regulatory review processes could present timing risks.

For a screening test targeting asymptomatic high-risk individuals, the sensitivity/specificity balance demonstrated in these studies represents a meaningful advancement over current capabilities, potentially enabling the shift toward earlier detection where surgical intervention remains the only curative option for pancreatic cancer.

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.

For more information, please contact:
Jeff Borcherding 
CEO and President 
jeff.borcherding@immunovia.com  

Immunovia in brief 

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 

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SOURCE Immunovia AB

FAQ

What is the detection rate of Immunovia's (IMMVF) new pancreatic cancer test?

The test successfully detects 77% of stage I and II pancreatic cancer cases, exceeding the 65% target and outperforming CA19-9's 69% detection rate.

When will Immunovia (IMMVF) launch its next-generation pancreatic cancer test?

Immunovia plans to launch the test commercially in the third quarter of 2025.

How accurate is Immunovia's (IMMVF) pancreatic cancer test compared to CA19-9?

The test shows 88% specificity compared to CA19-9's 89%, with superior sensitivity of 77% versus CA19-9's 69%.

Which patient groups were validated in Immunovia's (IMMVF) VERIFI study?

The test validated accuracy across high-risk groups including those with family history, genetic mutations, diabetes, and pancreatic cysts.

What regulatory steps remain for Immunovia's (IMMVF) pancreatic cancer test?

Additional clinical studies are planned throughout 2025 to support regulatory submissions and payer reimbursement efforts.