TOPLINE:

A blood-based biomarker test, PancreaSure, demonstrated high sensitivity and specificity in differentiating patients with early-stage pancreatic ductal adenocarcinoma (PDAC) from control individuals at high risk. The test outperformed CA19-9 alone, showing higher sensitivity across two independent clinical validation studies.

METHODOLOGY:

• Early detection of PDAC is important, particularly in patients at high risk due to family history or other factors.
• Researchers conducted two multicenter case-control studies to evaluate the performance of PancreaSure, a blood-based biomarker test, for early-stage pancreatic cancer.
• They included 317 patients with stages I-II PDAC and 1134 control individuals with high-risk factors such as pathogenic genetic variants, family history, or small pancreatic cysts (overall mean age, 63.2 years; 60.2% women; 81.7% White) from 21 US and two European sites.
• PancreaSure’s biomarker signature combined values for ICAM-1, THSB1, CTSD, TIMP1, and CA19-9, with a predefined cut-off for positive or negative results differentiating patients with early-stage disease from control individuals who were at high risk.
• The test’s performance was assessed using sensitivity and specificity metrics.

TAKEAWAY:

• PancreaSure demonstrated a sensitivity of 78% and specificity of 92% in detecting early-stage pancreatic cancer.
• The test significantly outperformed CA19-9 alone, which had a sensitivity of 66% (P < .001).
• The test showed high performance across subpopulations, including individuals with genetic or familial risk, diabetes, or small pancreatic cysts. Overall, the test showed higher sensitivity than CA19-9 (P < .05).
• In patients with high genetic or familial risk, PancreaSure achieved the highest specificity at 94%.

IN PRACTICE:

“These results further support the robustness of the test’s performance and can serve as a tool for early-stage PDAC detection in patients of varying high-risk profiles,” the authors of the study wrote.

SOURCE:

This study was led by Patricio M. Polanco, MD, University of Texas Southwestern in Dallas and was presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting, Phoenix, October 24-29, 2025.

LIMITATIONS:

No limitations were discussed in the abstract.

DISCLOSURES:

Polanco reported having no relevant financial relationships. Four authors disclosed advisory roles and/or being consultants with Immunovia. Three authors reported being employees of Immunovia.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.