Immunovia has announced positive results from its VERIFI study, the second clinical validation of its next-generation blood-based pancreatic cancer diagnostic test. The study met its primary endpoint by successfully detecting 77% of stage I and II cases of pancreatic ductal adenocarcinoma (PDAC), providing crucial validation for the test's accuracy in early-stage disease detection.
The VERIFI study analyzed 385 blood samples from six leading pancreatic cancer centers across the United States. Researchers evaluated 115 samples from patients with early-stage PDAC and compared them to 270 control samples from individuals without pancreatic cancer who were classified as high-risk due to family history, genetic mutations, pancreatic cysts, or combinations of these risk factors.
"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."
Jeff Borcherding, CEO of Immunovia, expressed enthusiasm about the results: "We are excited to see additional proof of the accuracy of our next-generation test. 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."
Clinical Significance and Market Potential
Pancreatic cancer remains one of the most aggressive malignancies, with a dismal five-year survival rate of just 13%. Early detection is paramount for improving patient outcomes, particularly for high-risk individuals. The disease is often diagnosed at advanced stages when treatment options are limited and less effective, making reliable early detection tools especially valuable.
Immunovia estimates that approximately 1.8 million individuals in the United States are at high risk for pancreatic cancer and could benefit from annual surveillance testing. This represents a significant market opportunity for the company's diagnostic technology.
High-risk populations include those with certain genetic mutations, family history of PDAC, and patients with pancreatic cysts such as intraductal papillary mucinous neoplasms (IPMNs). The latter group faces up to a 15% risk of progression to pancreatic cancer within 15 years, highlighting the importance of regular monitoring.
Commercial and Regulatory Strategy
Immunovia is actively preparing to launch its next-generation test in the third quarter of 2025. The company plans to conduct additional clinical studies throughout the year to further assess the test's clinical impact and evaluate its accuracy in various high-risk populations.
These additional studies will serve multiple purposes, including supporting regulatory submissions and strengthening the case for payer reimbursement. Securing insurance coverage will be critical for widespread adoption of the test, particularly in the United States, which represents the largest market for pancreatic cancer detection.
The company is also engaging with potential commercial partners to accelerate market adoption once the test is launched. This collaborative approach could help Immunovia overcome the challenges often associated with bringing novel diagnostic technologies to market.
Technology and Approach
Immunovia's diagnostic approach focuses on blood-based testing to detect proteins and antibodies that indicate pancreatic cancer development in high-risk individuals. This non-invasive method offers significant advantages over more invasive diagnostic procedures, potentially enabling more widespread screening of at-risk populations.
The company collaborates with healthcare providers, leading experts, and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer. This multidisciplinary approach helps ensure that the technology addresses real clinical needs and reaches the patients who could benefit most.
As Immunovia continues to generate clinical evidence supporting its next-generation test, the potential impact on pancreatic cancer outcomes could be substantial. Early detection remains the most promising strategy for improving survival rates in this challenging disease, and blood-based diagnostics like Immunovia's test may play a crucial role in shifting diagnosis to earlier, more treatable stages.
