76.1% vs 44.4%
Overall HCC sensitivity, HelioLiver vs ultrasound
The Pivotal Trial
The CLiMB Study
A prospective, blinded, multicenter US trial showing that HelioLiver, a simple blood test, detects hepatocellular carcinoma earlier than ultrasound in patients with cirrhosis. Now peer-reviewed and published in the Journal of Hepatology.
CLiMB at a Glance
One of the Largest US Liquid-Biopsy Liver Cancer Trials
1,968
patients enrolled
42
US clinical sites
MRI
gold-standard reference
2026
Journal of Hepatology
CLiMB is one of the largest completed prospective, multicenter liquid-biopsy liver cancer trials in the United States. It was designed to test a direct, clinically meaningful question: Can a simple blood test detect HCC earlier than the current standard of care, abdominal ultrasound, in the high-risk cirrhotic population that surveillance is meant to protect?
Study Design
A Rigorous, Real-World Study Design
Prospective & Blinded
Patients were enrolled prospectively, and samples were analysed blind to clinical outcome, reducing bias.
Head-to-Head
HelioLiver was compared directly against abdominal ultrasound, the guideline-recommended standard.
MRI-Truthed
HCC status was confirmed with contemporaneous multiphasic MRI, anchoring results to a clinical reference standard.
The validation cohort included 1,556 patients. The trial enrolled a real-world surveillance population: over half of the participants had obesity and/or metabolic liver disease (MASLD), the fastest-growing driver of HCC, and the group in whom ultrasound performs least reliably.
Clinical Performance
HelioLiver Detected HCC Earlier Than Ultrasound
71.9% vs 36.8%
early-stage HCC (BCLC 0/A)
61.5% vs 30.8%
very-early-stage HCC (BCLC 0)
87.6%
Specificity, non-inferior to ultrasound (93.9%)
47.8% vs 34.8%
vs ultrasound + AFP combined
97.8%
negative predictive value (vs 97.4%)
HelioLiver met its co-primary endpoints: superior sensitivity and non-inferior specificity compared with ultrasound. The advantage was greatest where it mattered most, the small, early-stage lesions that are most treatable and that ultrasound most often misses.
Tumour Size Analysis
The Advantage Is Greatest for Small, Early Tumours
| Tumour Size | HelioLiver | Ultrasound | Potential Treatment |
|---|---|---|---|
| ≤ 2 cm | 29% | 0% | Resection or transplant |
| > 2 cm to ≤ 3 cm | 54% | 31% | Ablation |
| > 3 cm | 75% | 75% | Chemotherapy (poorer prognosis) |
Reading the data — HelioLiver detected 29% of lesions under 2 cm, where ultrasound detected none. At larger sizes, the two converge, which is precisely why earlier detection changes the treatment options available to a patient.
Closing the Surveillance Gap
Why It Matters Clinically
Guidelines recommend HCC surveillance every six months for patients with cirrhosis, yet real-world adherence is poor and ultrasound's early-stage sensitivity is limited. CLiMB shows that a simple blood test can improve sensitivity for the earliest tumours while fitting into routine care as a simple blood draw, addressing both the detection gap and the adherence gap at once.
See How HelioLiver Fits Your Workflow
Peer-Reviewed
Read the Full Publication
Journal of
Hepatology
Peer-Reviewed
Hepatology
Published May 2026
Citation
Nguyen MH, et al. A Multi-Analyte cfDNA-based Blood Test for Early Detection of Hepatocellular Carcinoma. Journal of Hepatology, May 2026.
Read the Full PublicationBring Earlier Detection to Your Patients
HelioLiver gives physicians a validated, guideline-aligned way to detect HCC earlier, from a simple blood draw.