Immunovia, the leading pancreatic cancer diagnostics company, has announced that its next-generation test for detecting pancreatic cancer has been chosen for inclusion in a groundbreaking study funded by the US National Institutes of Health (NIH). The study, led by renowned expert Diane M. Simeone, aims to evaluate biomarker tests for monitoring cystic tumors of the pancreas.
The comprehensive clinical program will consist of three complementary studies. The first study will assess the performance and accuracy of blood-based biomarkers through a retrospective analysis of 200 blood samples, including early-stage pancreatic cancer cases and controls. The second study will evaluate the ability of the biomarker tests to detect early-stage pancreatic cancer in patients undergoing surgery to remove pancreatic cysts suspected to be cancerous. Lastly, the third study will examine biomarker performance for the detection of early-stage cancer in a group of individuals undergoing annual surveillance of cystic tumors.
With the first study expected to be completed in 2025 and the other two lasting approximately five years, this NIH-funded program represents a significant opportunity for Immunovia to validate the accuracy of its test and assess its clinical use in collaboration with top experts at leading US multidisciplinary pancreatic centers.
Immunovia’s CEO, Jeff Borcherding, expressed enthusiasm about the company’s inclusion in the program, stating, ‘Our inclusion in this program makes a strong statement about the promise of Immunovia’s next-generation test. We welcome the opportunity to validate the accuracy of our test and assess its clinical use in collaboration with top experts at leading U.S. multidisciplinary pancreatic centers. This NIH-funded program is a tremendous opportunity to rigorously study our test in patients with pancreatic cystic tumors and generate clinical data at a fraction of what it would cost the company to fund the study on our own.’
The study will be conducted through the PRECEDE Consortium, an international collaborative group of experts dedicated to improving early detection, screening, risk modeling, and prevention for pancreatic cancer patients. Dr. Simeone, the principal investigator and executive committee chair of the PRECEDE Consortium, is also a member of Immunovia’s Scientific Advisory Board.
Pancreatic cystic neoplasms (PCNs) are tumors of the pancreas that can be benign, precancerous, or cancerous. Accurate identification of PCNs and determining their risk for progression to invasive pancreatic cancer is crucial to prevent unnecessary procedures and enable early cancer diagnosis. The study aims to validate an effective early detection blood test for pancreatic cancer in patients with cystic tumors of the pancreas, addressing a critical unmet need for these patients.
Immunovia is committed to further validating the accuracy of its test with an independent clinical validation study in the fourth quarter of 2024. The company remains on track to launch the new test in the United States in 2025.
For more information, please contact:
Jeff Borcherding
CEO and President
Email: jeff.borcherding@immunovia.com
Phone: +46 709 11 56 08
Immunovia AB is a diagnostic company focused on increasing survival rates for patients with pancreatic cancer through early detection. The company collaborates with healthcare providers, experts, and patient advocacy groups to make its test available to individuals at high risk for pancreatic cancer. Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm.