Immunovia has unveiled a significant advancement with its next-generation pancreatic cancer test, aimed at enhancing survival rates through early detection. The new test has successfully met primary and secondary endpoints in a model-development study.

According to the findings, Immunovia's next-generation test demonstrates a specificity of 98 percent and sensitivity of 75 percent in detecting early stages (1 and 2) of pancreatic ductal adenocarcinoma (PDAC), the most common and aggressive form of pancreatic cancer. Notably, the test surpasses CA19-9, a commonly used biomarker for pancreatic cancer detection.

These results highlight the technical improvements over Immunovia's initial offering, IMMray PanCan-d. This new test integrates high-performing protein biomarkers, reducing reliance on CA19-9, which is ineffective in approximately 10 percent of patients, including many of African ancestry.

Moreover, the new test eliminates indeterminate or "borderline" results, providing clear positive or negative classifications for pancreatic cancer, unlike IMMray PanCan-d, which often led to uncertainty for clinicians.

Implemented on a widely used ELISA platform, the next-generation test allows for more precise protein measurements, faster testing, and reduced costs.

Jeff Borcherding, CEO and President of Immunovia, expressed optimism about the potential of their test to transform early pancreatic cancer detection and improve patient survival rates. He emphasized the urgent need for a simple, rapid, and non-invasive blood test for individuals at risk of pancreatic cancer.

The model development study involved 481 blood samples from the U.S. and Europe, including 133 samples from patients with stage 1 or 2 PDAC and 348 control samples representing various demographics.

Immunovia plans to proceed to a second phase of the model development study to further refine the test model and assess performance in a more selective patient cohort.

In the subsequent quarters of 2024, Immunovia will conduct analytical validation steps to verify the accuracy and reproducibility of protein biomarker measurements. The company aims to conduct a large clinical validation study in the fourth quarter of 2024, paving the way for a U.S. launch in 2025.

With an estimated 600,000 high-risk individuals in the U.S. alone, Immunovia's innovative test holds promise for making pancreatic cancer surveillance faster, more convenient, and less invasive, fulfilling a strong demand from high-risk individuals and leading pancreatic cancer surveillance centers.

 

Source: prnewswire.com

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