LUND (SWEDEN) - 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.
