Diagnostics company Immunovia announced positive results for the newest generation of its pancreatic cancer test from a model-development study, announcing that the test achieved both its primary and secondary endpoints.
In a statement, Immunovia said that the next-generation test, which builds on its IMMray PanCan-d test, had a specificity of 98% and a sensitivity of 75% in detecting early stages (I and II) of pancreatic ductal adenocarcinoma (PDAC), an aggressive pancreatic cancer that is also the most common form of the disease.
Furthermore, the next-generation test includes high-performing protein biomarkers, making the test less reliant on CA19-9, a biomarker in common use for pancreatic cancer detection. Approximately 10% of patients don't produce CA9-19, particularly those with African ancestry. The firm noted that the results included PDAC patients with low CA19-9 values.
The next-generation test also does not provide "indeterminate" results, unlike the first-generation IMMray PanCan-d test, classifying all patients as either negative or positive for pancreatic cancer and thus assisting clinicians in earlier decision-making.
The firm says that it will now move to the second phase of the model-development study, in which it will conduct additional statistical analyses to refine and assess the robustness of the test model. This phase is expected to be completed in six to eight weeks. In addition, the test's performance will be evaluated in a cohort of patients at high risk for pancreatic cancer.
Immunovia said that it plans to perform analytical validation steps to verify the accuracy and reproducibility of the protein biomarker measurements in the second and third quarters of 2024. In the fourth quarter of 2024, the company will conduct a large clinical validation study to confirm the test's performance, with U.S. launch anticipated in 2025.
