Proven accuracy in early detection

How PancreaSure works
Pancreatic cancer tumors leave traces in the blood before they cause symptoms. From a simple blood draw, PancreaSure reads five biomarkers and combines them into a proprietary algorithm to provide a clear positive or negative answer within days. The test is designed for individuals at high risk of pancreatic ductal adenocarcinoma (PDAC) due to genetic mutations, family history, or pancreatic cysts, where it complements imaging in annual surveillance.

Validated, confirmed, published
Before any patient study, PancreaSure’s precision, stability, and reproducibility were documented an analytical validation study of more than two dozen experiments. Three clinical validation studies followed, demonstrating the clinical accuracy (sensitivity and specificity) of the test. Pooled analysis in the Medicare intended population demonstrated the accuracy of PancreaSure in this group:

* Sensitivity is the proportion of people with the condition correctly identified as positive, meaning how well the test detects cancer in those who have it.
** Specificity is the proportion of people without cancer correctly identified as negative, meaning how well the test clears those who do not have disease.

Across the combined studies, sensitivity was 77.6% in early-stage (I–II) pancreatic cancer, with specificity of 92% in high-risk controls and 98% in healthy controls. MRI and CT, two traditional surveillance methods, each detect only about half of early-stage pancreatic cancers, indicating strong potential for PancreaSure to increase early detection high-risk individuals.

Evidence beyond accuracy
Immunovia has developed strong evidence of analytical validity and clinical validity (i.e., accuracy) of PancreaSure. To secure insurance coverage and drive adoption, the company is focused on generating evidence of clinical utility, meaning the test changes clinician and patient behavior and improves patient outcomes. Immunovia is demonstrating clinical utility through surveys and retrospective studies as well as prospective clinical studies.

Ongoing survey and retrospective studies

• DECIDE – physician survey with the PRECEDE consortium: measures how PancreaSure results change patient management, a clinical-utility evidence that Medicare weighs heavily.
• ADHERE – patient survey with the advocacy organization FORCE: among 392 high-risk individuals, more than nine in ten expressed interest in blood-based testing, only about four in ten were part of surveillance and more than a third had never undergone a screening test.
• ASSURE – a real-world registry led by Northwestern Medicine that will follow PancreaSure in routine use at approximately 15 U.S. sites.
• Kaiser Permanente – retrospective study of blood samples drawn up to three years before diagnosis to determine whether PancreaSure can find cancer before imaging does.

Ongoing prospective clinical studies

• Pancreatic cyst studies – in collaboration with UC San Diego Health and the National Institutes of Health, these studies aim to assess PancreaSure sensitivity and specificity in detecting cancer in patients with pancreatic cysts, growths on the pancreas that pose the risk becoming cancerous.
• BEACON (specificity) – aims to prospectively define PancreaSure's specificity and false positive rate in a high-risk surveillance population.
• RADAR (sensitivity) – aims to prospectively measure PancreaSure's sensitivity in patients with suspicious CT or MRI scans.