Immunovia AB (IMMNOV: Nasdaq Stockholm), a pancreatic cancer diagnostic company, today announced that the final results from the AFFIRM clinical study have been published in the Journal of Clinical Oncology: Oncology Advances. The results show 88% sensitivity and 98% specificity for PancreaSure in late-stage pancreatic cancer patients and healthy, average-risk individuals, respectively, consistent with previously reported interim data.
The AFFIRM study demonstrated that PancreaSure achieved 88% sensitivity in detecting Stage III and Stage IV pancreatic cancers and 98% specificity in correctly classifying control samples as non-cancerous. The study included blood samples from 619 individuals: 105 Stage III and 119 Stage IV pancreatic cancer samples from the Immunovia biobank, originally acquired from five European pancreatic cancer programs, along with 395 healthy control samples. These results expand and reinforce the previously reported CLARITI and VERIFI data by adding evidence of strong performance in advanced-stage disease. Importantly, the inclusion of a healthy control population for the specificity analysis aligns with methodology commonly used in the broader cancer detection field, enabling more direct benchmarking of PancreaSure against other tests.
"With the publication of the AFFIRM results, we expand the robust body of clinical evidence supporting PancreaSure's performance across both early and advanced-stage pancreatic cancer. This strengthens our position as we continue the commercial rollout in the United States. Looking ahead, we expect to deliver additional clinical results in 2026 and 2027 through our planned registry study and multiple clinical utility studies, which will further demonstrate the real-world value of PancreaSure for patients and clinicians," says Jeff Borcherding, CEO and President, Immunovia.
The AFFIRM study was designed to complement Immunovia's prior clinical validation studies, CLARITI and VERIFI, which focused on Stage I and Stage II pancreatic cancer and evaluated specificity in high-risk individuals – including those with family history, genetic mutations, or pancreatic cysts. AFFIRM addressed two additional objectives: measuring PancreaSure's sensitivity in detecting advanced-stage (Stage III and Stage IV) pancreatic cancer, and assessing specificity in healthy, average-risk individuals. Together, the three studies provide a comprehensive clinical evidence base spanning all major disease stages and both high-risk and average-risk populations.
For more information, please contact:
Jeff Borcherding
CEO and President
jeff.borcherding@immunovia.com
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.