Research Findings Presented at the American Pancreatic Association (APA) 2025
Cosomil, Inc. presented the results of a collaborative study on pancreatic cancer biomarker discovery at the American Pancreatic Association (APA) 2025 Annual Meeting, held on November 12–15, 2025 (PST).
This work was conducted in collaboration with Dr. Takashi Kobayashi and Dr. Yuzo Kodama of the Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine.
In this study, we explored novel enzymatic activity–based biomarkers for pancreatic cancer using our proprietary ultra-sensitive single-molecule liquid biopsy platform.
Methods
We systematically screened candidate biomarkers using over 100 fluorogenic enzyme substrates across a total of 690 plasma samples collected from 12 hospitals/biobanks in Japan and the United States.
Identified biomarker candidates were subsequently combined into a classification model.
The model was trained and fixed using a training dataset, and its performance was independently evaluated on a validation dataset with no institutional overlap.
Results
We identified four pancreatic enzyme activity–based biomarkers:
- DPP4/FAPα
- CTRB2
- CTRB1/CTRB2
- CELA3A
A classification model combining these biomarkers demonstrated the following performance:
- Sensitivity: 75.0% (stage I–IV pancreatic cancer)
- Specificity: 95.5%
- ROC-AUC: 0.91
This performance statistically exceeded that of the conventional tumor marker CA19-9 (ROC-AUC: 0.75). Importantly, the model maintained high sensitivity even in early-stage disease (stage I–II: 74.2%, UICC 8th edition), indicating strong potential for early detection. Furthermore, the positivity rate in non-pancreatic malignancies was 12.7%, lower than that of CA19-9 (20.4%), suggesting improved disease specificity for pancreatic cancer.
Perspectives
Based on these findings, we are developing the blood-based pancreatic cancer screening test and are currently conducting a prospective clinical study (Principal Investigator: Dr. Keiji Hanada, JA Onomichi General Hospital; UMIN Trial ID: UMIN000059647).
This study aims to evaluate clinically relevant metrics, including detection rate and positive predictive value, and to generate evidence to support the design of future large-scale clinical trials.
We are also advancing development toward regulatory approval as an in vitro diagnostic (IVD) product in Japan and the US.
Conference Presentation Information
Session: Lunch & Posters (12:15 pm – 2:00 pm, November 13)
Title: Early detection of pancreatic cancer using a single-molecule enzyme activity–based liquid biopsy platform（PDF）
Annual Meeting Website: Annual Meeting – American Pancreatic Association