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Integrated cytologic, biochemical, imaging, and molecular analysis of pancreatic cystic lesions using PancreaSeq: a
Jing Wang1, Wei Sun2, Tamas A Gonda3
1Department of Pathology, New York University Langone Health, New York City, New York; Department of Pathology, Moffitt Cancer Center, Bronx, New York.
Journal of the American Society of Cytopathology
|April 2, 2026
Summary
PancreaSeq Genomic Classifier (GC) enhances pancreatic cyst diagnosis and risk assessment, especially for indeterminate cytology cases. This molecular analysis offers significant value, improving cyst classification and dysplasia risk stratification.
Area of Science:
- Gastroenterology
- Oncology
- Molecular Diagnostics
Background:
- Accurate preoperative evaluation of pancreatic cysts is crucial for patient management.
- Cytology and biochemical analyses have limitations due to low cellularity and variable accuracy.
- Risk stratification is critical for determining the appropriate management of pancreatic cysts.
Purpose of the Study:
- To evaluate the diagnostic and risk-stratification performance of the PancreaSeq Genomic Classifier (GC) for pancreatic cyst fluid analysis.
- To assess the added value of molecular profiling compared to traditional cytology and biochemical markers.
- To determine the utility of PancreaSeq GC in indeterminate or nondiagnostic cytology specimens.
Main Methods:
- Retrospective analysis of 219 pancreatic cysts from 206 patients using PancreaSeq GC.
- Integration of molecular findings with cytology, biochemical data, imaging, surgical pathology, and follow-up.
- Evaluation of concordance with cytology and correlation with surgical pathology for performance metrics.
Main Results:
- PancreaSeq GC successfully analyzed 99% of cysts, detecting alterations in 83%.
- High concordance was observed with cytology for mucinous neoplasms (94%) and atypical cases (95%).
- PancreaSeq GC identified mucinous neoplasms in 64% of cases with initially nondiagnostic cytology, demonstrating significant added value. It showed excellent performance in distinguishing mucinous from nonmucinous cysts (AUC=0.94) and risk stratification for dysplasia (AUC=0.78 for any dysplasia, AUC=0.74 for high-grade dysplasia).
Conclusions:
- PancreaSeq GC significantly complements cytological evaluation for pancreatic cysts, especially in indeterminate or nondiagnostic cases.
- Molecular profiling improves cyst classification and dysplasia risk assessment, offering value when biochemical data are unavailable.
- Multidisciplinary assessment remains essential due to the assay's limitations in detecting focal high-grade dysplasia and certain cyst types like serous cystadenomas.
