Immunovia's Next-Gen Pancreatic Cancer Test Shows Promising Results in VERIFI Study

In the relentless battle against pancreatic cancer, early detection remains the holy grail. Immunovia, a Swedish diagnostics company, has taken a significant step forward with its next-generation pancreatic cancer test, as revealed in the VERIFI study. The results, announced on March 19, 2025, show a sensitivity of 77% in detecting stage I and II pancreatic cancer, reinforcing the test's potential to revolutionize early diagnosis.

The VERIFI study, conducted using 385 blood samples from six leading pancreatic cancer centers in the U.S., met its primary endpoint. This marks the second clinical validation of Immunovia's next-generation test, following the successful CLARITI study in December 2024. The CLARITI study, which involved over 1,000 patient samples, demonstrated a sensitivity of 78% and a specificity of 94% in detecting early-stage pancreatic ductal adenocarcinoma (PDAC).

The slight difference in sensitivity between the two studies—77% in VERIFI versus 78% in CLARITI—can be attributed to several factors. The VERIFI study had a smaller sample size and a higher proportion of PDAC samples. Additionally, the VERIFI study included patients with pancreatic cysts, a known risk factor for pancreatic cancer. This inclusion could have influenced the test's performance, as pancreatic cysts may present biomarkers that are indicative of early-stage pancreatic cancer.

The implications of the VERIFI study's inclusion of patients with pancreatic cysts are significant. Pancreatic cysts are a known risk factor for pancreatic cancer, with up to 15% progressing to pancreatic cancer within 15 years. By including these patients in the study, Immunovia is testing the test's ability to detect early-stage pancreatic cancer in a high-risk population. This is a critical step in improving patient outcomes, as early detection is key to increasing survival rates for pancreatic cancer patients.

However, the inclusion of pancreatic cysts could also decrease the test's specificity, as some patients with pancreatic cysts may not have pancreatic cancer. Therefore, further analysis of the VERIFI study data is needed to determine the impact of pancreatic cysts on the test's accuracy and applicability.

Despite these considerations, the VERIFI study's results are encouraging. 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. This success positions Immunovia as a leader in the early-detection market and brings the company closer to fulfilling its mission of improving pancreatic cancer survival worldwide.

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.

In conclusion, the VERIFI study's results are a promising step forward in the fight against pancreatic cancer. Immunovia's next-generation test has the potential to revolutionize early diagnosis, improving patient outcomes and saving lives. As the company prepares for the test's launch, the biotech community and patients alike will be watching closely, hoping that this innovative diagnostic tool will live up to its promise.