Pancreatic cancer diagnostics company Immunovia (Nasdaq Stockholm: IMMNOV) announced on Wednesday that it has completed the analytical validation of its next-generation test for early-stage pancreatic cancer detection.

Results confirmed the test's reliability and robustness across a comprehensive range of performance parameters.

Experiments evaluated over 23 key performance attributes, adhering to guidelines from the Clinical and Laboratory Standards Institute (CLSI) and meeting the standards of the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP). Validation highlights include high precision and reproducibility, accurate readings at varying biomarker concentrations, high sensitivity for low-level biomarker detection, stability under various conditions and consistent performance across different laboratory settings.

The validation utilised an automated ELISA analyzer, significantly improving performance and throughput compared to Immunovia's previous IMMray platform.

Following this validation, Immunovia has launched a large-scale clinical validation study to assess the test's accuracy in detecting stage 1 and 2 pancreatic cancer, expected to conclude by December 2024. Results will provide insights into clinical performance metrics, including sensitivity and specificity.

Focused on early detection, Immunovia develops blood-based tests to identify proteins and antibodies indicative of high-risk pancreatic cancer. The company estimates that approximately 1.8 million individuals in the USA are at high risk and could benefit from annual surveillance testing.