Immunovia announces another successful clinical validation of its next-generation pancreatic cancer test

Rhea-AI Summary

Immunovia (IMMNOV: Nasdaq Stockholm) has announced positive results from the VERIFI study, their second clinical validation study of their next-generation pancreatic cancer test. The test successfully achieved its primary endpoint by detecting 77% of stage I and II pancreatic cancer cases.

Dr. Patricio Polanco from the Harold C. Simmons Comprehensive Cancer Center highlighted the test's high accuracy in detecting early-stage PDAC in high-risk patients. CEO Jeff Borcherding emphasized that this second successful validation will support insurance reimbursement efforts.

The company plans to launch the next-generation test in Q3 2025. Additional clinical studies are planned throughout the year to evaluate clinical impact and accuracy in other high-risk populations, supporting regulatory submissions and payer reimbursement. Immunovia is also seeking commercial partners to accelerate market adoption.

Positive

• 77% detection rate for early-stage (I and II) pancreatic cancer
• Second successful clinical validation strengthens reimbursement potential
• Clear commercialization timeline with Q3 2025 launch

Negative

• Additional clinical studies still required for regulatory approval
• Commercial partnerships not yet secured
• Insurance reimbursement pending

LUND, Sweden, March 19, 2025 /PRNewswire/ -- Immunovia (IMMNOV: Nasdaq Stockholm), the pancreatic cancer diagnostics company, today announced positive results from the VERIFI study, the second clinical validation study of its next-generation pancreatic cancer test. The study met its primary endpoint, with the test successfully detecting 77% of stage I and II cases of pancreatic cancer.

"The high accuracy of the Immunovia test in detecting stage I and II PDAC in a second independent clinical population of high-risk patients is very encouraging," said Dr. Patricio Polanco, Co-Director of the Pancreatic Cancer Program and the Pancreatic Cancer Prevention Clinic at the Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center. "Additional biomarkers to support the diagnosis of patients with early-stage disease are critical for improving long-term oncologic outcomes in pancreatic cancer." 

"We are excited to see additional proof of the accuracy of our next-generation test," said Jeff Borcherding, CEO of Immunovia. "Completing a second successful clinical validation study will strengthen our efforts to secure insurance reimbursement for the test. We look forward to sharing additional data and analysis from the VERIFI study in upcoming scientific meetings and publications." 

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 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 further information, please contact
Jeff Borcherding, CEO
jeff.borcherding@immunovia.com

The information in this report is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 13:15 am CET on March 19, 2025.

Immunovia in brief

Immunovia AB 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.

This information was brought to you by Cision http://news.cision.com.

https://news.cision.com/immunovia-ab/r/immunovia-announces-another-successful-clinical-validation-of-its-next-generation-pancreatic-cancer-,c4121168

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Press release (PDF)

 

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SOURCE Immunovia AB

FAQ

What were the detection rates for Immunovia's (IMMNOV) new pancreatic cancer test in the VERIFI study?

The test successfully detected 77% of stage I and II pancreatic cancer cases in high-risk patients.

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

Immunovia plans to launch the next-generation test in the third quarter of 2025.

What are the next steps for Immunovia's (IMMNOV) pancreatic cancer test development?

The company will conduct additional clinical studies to assess clinical impact and accuracy in other high-risk populations, while pursuing regulatory submissions and payer reimbursement.

How will the VERIFI study results impact Immunovia's (IMMNOV) business strategy?

The successful validation will strengthen insurance reimbursement efforts and support partnership discussions with potential commercial partners.