Richard Van Etten, MD, PhD
Chief Medical Advisor
Clinical Evidence
Clinical Evidence
HelioLiver LDT delivers superior performance characteristics when compared to traditional testing for HCC.
CLiMB Trial — Published
The CLiMB Trial Results
Peer-Reviewed Journal
Journal of
Hepatology
Hepatology
Published May 2026
Pivotal Study
A Prospective, Multicenter Validation
The CLiMB trial is a prospective, blinded, multicenter US evaluation of HelioLiver — a multi-analyte blood-based test combining cell-free DNA methylation, serum protein markers, and clinical information — for the detection of hepatocellular carcinoma (HCC) in patients with cirrhosis. These results are now peer-reviewed and published in the Journal of Hepatology.
Published
Peer Reviewed
Multicenter Study
Prospective Trial
Read the Publication in the Journal of Hepatology
Sensitivity by Tumour Size
Higher Sensitivity for Small, Early-Stage Tumours
≤ 2 cmResection or transplant
> 2–3 cmAblation
> 3 cmChemotherapy (poorer prognosis)
SOURCE: CLiMB trial. Published in the Journal of Hepatology, May 2026.
Reading the data
HelioLiver's advantage over ultrasound is greatest for the smallest, most treatable tumours — detecting 29% of lesions under 2cm where ultrasound detected none. At larger sizes the two converge, which is why early detection matters most.
A Consistent Body of Evidence
Validated Across Two Clinical Studies
CLiMB builds on Helio's earlier ENCORE study, published in Hepatology Communications, in which HelioLiver demonstrated 76% sensitivity for early-stage HCC — outperforming AFP (57%), the GALAD score (65%), and ultrasound (47%) at 91% specificity. Together, ENCORE and the pivotal CLiMB trial form a consistent body of evidence supporting HelioLiver's performance in high-risk patients.
ENCORE Study
ENCORE
Published in Hepatology Communications
HelioLiver demonstrated 76% sensitivity for early-stage HCC, outperforming AFP, the GALAD score, and ultrasound at 91% specificity.
76%
early-stage sensitivity
91%
specificity
CLiMB Trial
CLiMB
Published in the Journal of Hepatology
A prospective, blinded, multicenter US trial validating HelioLiver for HCC detection in patients with cirrhosis — confirming consistent clinical performance.
Pivotal
prospective trial
Multi
center US study
Data Presentation Video
Watch the Data Presentation
Listen to Helio's data presentation at the 2024 European Association for the Study of the Liver (EASL) Congress.
Scientific Advisory
Our Scientific Advisors
Wei Li, PhD
Chief Bioinformatics Advisor
Mindie Nguyen, MD, MAS, AGAF, FAASLD
Hepatology Advisor and Lead Principal Investigator in CLiMB
Robert Gish, MD
The Hepatitis B Foundation
Why It Matters
Why Clinical Evidence Matters
Peer-Reviewed Science
Our results are validated by independent experts and published in leading journals.
Early Detection
Higher sensitivity for small, early-stage tumours — when treatment works best.
Clinical Validation
Demonstrated in prospective, multicenter trials in real high-risk patients.
Precision Oncology
Molecular signals interpreted with AI for accurate, individualised answers.
Improved Patient Outcomes
Earlier diagnosis expands treatment options and improves survival.
Evidence-Based Innovation
Every advance is grounded in rigorous, reproducible scientific research.
Want to Learn More?
Our team is happy to hear from you and answer any questions you may have.