Immunovia, a Swedish diagnostics company, said that its next-generation pancreatic cancer test has met both primary and secondary endpoints in a model-development study.
In the trial, Immunovia’s advanced test showed a specificity of 98% and sensitivity of 75% in identifying stage one and two pancreatic ductal adenocarcinoma (PDAC).
The Immunovia test also outperformed CA19-9, a commonly used biomarker for pancreatic cancer detection.
According to the diagnostics firm, the positive results mark a technical advancement from its first-generation test, IMMray PanCan-d.
The next-generation test, whose development started in July last year, incorporates high-performing protein biomarkers, which reduces its reliance on CA19-9.
Additionally, Immunovia claimed that the test successfully identified PDAC patients even with low CA19-9 levels.
The new test is also designed to eliminate indeterminate results, providing clear positive or negative diagnoses for pancreatic cancer.
Unlike the IMMray PanCan-d test, which occasionally yielded borderline outcomes for about 10% of patients, the next-generation test offers definitive results.
Based on the widely used ELISA platform, the next-generation test ensures more precise protein measurement, quicker testing, and reduced costs, said the firm.
Immunovia CEO and president Jeff Borcherding said: “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.”
The model development study aimed to select the most effective biomarkers for the next-generation test, establish the algorithm to generate a diagnostic result, and assess its initial clinical performance.
This study comprised 481 blood samples, including 133 from stage one or two PDAC patients, and 348 control samples representing different subjects at varying risk levels.
Immunovia will progress to the next phase of the model development study, which is anticipated to conclude in six to eight weeks. It will focus on refining and validating the test model through additional statistical analyses.
Furthermore, the test’s performance will be assessed in a more selective cohort of high-risk pancreatic cancer patients.
The diagnostics company will undertake multiple analytical validation steps throughout Q2 and Q3 2024 to verify the accuracy and reproducibility of protein biomarker measurements.
In Q4 2024, a large-scale clinical validation study will be conducted to confirm the next-generation test’s performance, paving the way for a US launch in 2025.
