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HES V2.0 validation and performance compared to GALAD and ASAP in the HEDS cohort
Hashem B El-Serag1, Camden Lopez2, Michelle Luster3
1Section of Gastroenterology and Hepatology, Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, United States; Houston VA Health Services Research and Development Service Center of Excellence Houston, Texas, Section of Health Services Research, Michael E. DeBakey VA Medical Center, Houston, Texas, United States.
Journal of Hepatology
|October 3, 2025
Summary
The HES V2.0 biomarker panel shows improved sensitivity for early hepatocellular carcinoma (HCC) detection in cirrhosis patients compared to existing models. This panel is particularly effective when using temporal biomarker gradients for enhanced liver cancer surveillance.
Area of Science:
- Hepatology and Oncology
- Biomarker Discovery and Validation
- Cancer Early Detection
Background:
- Hepatocellular carcinoma (HCC) is a major cause of cancer mortality, necessitating early detection strategies.
- Previous development of the HES V2.0 biomarker panel for early HCC detection in cirrhosis patients.
- External validation of HES V2.0 against HES V1.0, GALAD, and ASAP models.
Purpose of the Study:
- To externally validate the HES V2.0 biomarker panel.
- To compare the diagnostic performance of HES V2.0 with HES V1.0, GALAD, and ASAP for HCC detection.
- To assess the utility of temporal gradients in biomarker levels for HCC detection.
Main Methods:
- Prospective specimen-collection, retrospective blinded-evaluation (PRoBE) cohort study.
- Inclusion of 1,485 patients with cirrhosis, with 119 developing HCC.
- Calculation of true positive rates (TPR) at fixed false positive rates (FPR) of 10% and 18.1% at 6, 12, and 24 months pre-diagnosis.
Main Results:
- HES V2.0 demonstrated higher sensitivity than ASAP and comparable or superior sensitivity to GALAD at 10% FPR, especially at 12 months pre-diagnosis.
- At 10% FPR, HES V2.0 showed 6.7% higher sensitivity than GALAD at 12 months (p=0.025).
- HES V2.0 significantly outperformed GALAD when temporal gradients were utilized (8.7-24.0% relative increase, p<0.05).
Conclusions:
- HES V2.0 offers enhanced sensitivity for early HCC detection in cirrhosis patients compared to ASAP and GALAD.
- The inclusion of temporal biomarker gradients significantly improves HES V2.0's performance.
- HES V2.0 shows promise for integration into clinical practice for improved liver cancer surveillance.
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