Immunovia (NASDAQ Stockholm: IMMNOV), the diagnostics company with the mission to increase pancreatic cancer survival through early detection, today announces its next-generation pancreatic cancer test achieved both the primary and secondary endpoints in a model-development study. 

In the study, Immunovia's next-generation test demonstrated specificity of 98 percent and sensitivity of 75 percent in detecting early stage (1 and 2) pancreatic ductal adenocarcinoma (PDAC), a very aggressive and the most common form of pancreatic cancer. The Immunovia test was also significantly more accurate than CA19-9, the biomarker commonly used to detect pancreatic cancer. 

Credit: fernando zhiminaicela from Pixabay

Importantly, these results confirm the technical advancement of the next-generation test over Immunovia's first-generation test, IMMray PanCan-d. The next-generation test includes high-performing protein biomarkers, making the test less reliant on CA19-9. This is a major achievement as around 10 percent of patients, including many patients of African ancestry, do not produce CA19-9, so the IMMray PanCan-d test could not be used in those patients. The results with the new test were achieved including PDAC patients with low CA19-9 values.  

Furthermore, the new test does not provide indeterminate or "borderline" results; all patients are classified as positive or negative for pancreatic cancer. With the first-generation Immunovia test, IMMray PanCan-d, about 10 percent of patients received a test result of "borderline", creating indecision for clinicians.  

The next-generation test is now established on a broadly used ELISA platform, resulting in more precise protein measurement, faster testing, and lower cost of goods sold. 

"Pancreatic cancer is a brutal and lethal cancer. People at risk for pancreatic cancer need a simple, fast, and easy blood test to detect cancer early. We are very excited about the potential of our test to meet this need and increase survival rates for these patients," says Jeff Borcherding, CEO and President of Immunovia. 

The model development study was designed to select the highest performing biomarkers to include in the next-generation test, to define the algorithm to produce a diagnostic result, and to provide an initial assessment of the test's clinical performance. The study included 481 blood samples from the U.S. and Europe. Of these, 133 were samples from patients with stage 1 or 2 PDAC. The 348 control samples represented a wide range of subjects, including people at high-risk for hereditary and familial pancreatic cancer, diabetics, patients with benign pancreatic lesions worrisome for PDAC, and healthy individuals. 

Immunovia will now move to a second phase of the model development study, expected to be completed in 6 – 8 weeks, in which it will conduct additional statistical analyses to refine and assess the robustness of the test model. In addition, test performance will be evaluated in a more selective cohort of patients at high risk for pancreatic cancer.  

In the second and third quarters of 2024, Immunovia will perform several analytical validation steps to verify the accuracy and reproducibility of the protein biomarker measurements. In the fourth quarter of 2024, the company will conduct a large clinical validation study to confirm the performance of the next-generation test, setting the stage for a U.S. launch in 2025.

Immunovia estimates that there are at least 600,000 individuals in the U.S. at high risk of pancreatic cancer due to family history and genetic mutations. Many more are at risk due to other factors. The current standard of care for surveillance is annual imaging using magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS). High-risk individuals and clinicians at leading high-risk pancreatic cancer surveillance centers have expressed a very strong desire for a simple blood test to make surveillance faster, more convenient, and less invasive.