47.8% vs 28.3%
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. Peer-reviewed and published in the Journal of Hepatology.
CLiMB at a Glance
One of the Largest US Liquid-Biopsy Liver Cancer Trials
1,268
evaluable participants
42
US clinical sites
MRI
gold-standard reference
2026
Journal of Hepatology
CLiMB is the first blinded, multicenter, prospective US study to compare a multi-analyte blood test against abdominal ultrasound for detecting HCC in patients with cirrhosis. Every participant had a blood draw, an ultrasound, and a multiphasic MRI, with MRI serving as the reference standard for the clinical truth.
Study Design
A Rigorous, Real-World Design
Prospective & Blinded
Participants were enrolled prospectively and the test was run 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 set by multiphasic MRI, read centrally by board-certified radiologists using LI-RADS.
Of 1,556 enrolled participants, 1,268 were evaluable, including 46 with confirmed HCC. More than 80% were enrolled at community-based centres rather than specialist academic hospitals, so the results reflect real-world screening. The cohort matched the patients surveillance is meant to protect: 55% were obese and around half had metabolic liver disease (MASLD), the fastest-growing driver of HCC and the group in whom ultrasound is least reliable.
Clinical Performance
HelioLiver Detected HCC Earlier Than Ultrasound
40% vs 10%
early-stage (T1) HCC, a 4-fold difference
28.6% vs 0%
sensitivity for lesions ≤2 cm, where ultrasound found none
87.6%
Specificity, non-inferior to ultrasound (93.9%)
47.8% vs 34.8%
vs ultrasound + AFP combined
97.8%
negative predictive value (vs 97.2%)
HelioLiver met both prespecified co-primary endpoints: superior sensitivity and non-inferior specificity compared with ultrasound. Its advantage was greatest where it matters most, the small, early-stage tumours that are most treatable and that ultrasound most often misses. For early T1 disease, HelioLiver detected four times as many cancers as ultrasound, and it identified more HCC than ultrasound combined with AFP.
Tumour Size Analysis
The Advantage Is Greatest for Small, Early Tumours
| Largest Lesion Size | HelioLiver | Ultrasound |
|---|---|---|
| ≤ 2 cm | 28.6% | 0% |
| > 2 to ≤ 3 cm | 53.8% | lower |
| Early-stage (T1 overall) | 40.0% | 10.0% |
Reading the data — Ultrasound failed to detect a single tumour under 2 cm. HelioLiver found nearly 29% of them, the lesions where curative options like resection and transplant are still possible. As tumours grow, all tests improve, which is precisely why earlier detection matters so much.
Closing the Surveillance Gap
Why It Matters Clinically
Guidelines recommend HCC surveillance every six months for patients with cirrhosis, yet fewer than 25% receive it, and at community centres adherence falls to around 9%. Ultrasound also struggles with small tumours and is affected by body habitus and operator experience. CLiMB shows that a simple blood test can improve sensitivity for the earliest tumours while fitting into routine care as a simple blood draw, helping close both the detection gap and the adherence gap.
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Peer-Reviewed
Read the Full Publication
Journal of
Hepatology
Peer-Reviewed
Hepatology
Published May 2026
Citation
Taggart DJ, Mahajan S, Gallant MA, et al. A multi-analyte cfDNA-based blood test for early detection of hepatocellular carcinoma. Journal of Hepatology. 2026. doi:10.1016/j.jhep.2026.04.012. ClinicalTrials.gov NCT03694600.
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HelioLiver gives physicians a validated, guideline-aligned way to detect HCC earlier, from a simple blood draw.