A landmark CLiMB study published in the Journal of Hepatology shows HelioLiver™ detects more early HCC than abdominal ultrasound in patients with cirrhosis — 47.8% vs 28.3% overall, and 28.6% vs 0% for lesions under 2 cm.
Prospective multicenter trial shows HelioLiver™ detects more early hepatocellular carcinoma than abdominal ultrasound for high-risk patients with cirrhosis.
IRVINE, Calif., May 6, 2026 /PRNewswire/ — Helio Genomics, an AI-powered TechBio company focused on early cancer detection, today announced the publication of a study in the Journal of Hepatology demonstrating the performance of HelioLiver™, its multi-analyte noninvasive blood test, for the early detection of hepatocellular carcinoma (HCC). The peer-reviewed article, “A Multi-Analyte cfDNA-based Blood Test for Early Detection of Hepatocellular Carcinoma,” reports results from the CLiMB clinical trial and highlights the test’s ability to detect early-stage disease in patients with cirrhosis, compared with standard-of-care liver ultrasound — a surveillance method adhered to in only a minority (9%) of patients with cirrhosis, according to a nationwide U.S. real-world study of over 80,000 patients.1 The study is also listed among our publications.
The CLiMB study is the largest completed prospective, multicenter, blinded U.S. clinical trial for a liver cancer detection liquid biopsy test. It enrolled 1,968 patients with cirrhosis across 42 clinical sites, of whom 1,556 were assigned to a validation cohort to compare HelioLiver™ — combining cfDNA methylation patterns, serum protein markers, and demographic information — to standard abdominal ultrasound. Unlike many other studies, CLiMB included contemporaneous multiphasic MRI for all participants as the gold standard for clinical truth. The HelioLiver™ test met two pre-specified co-primary endpoints for superior sensitivity and non-inferior specificity compared to ultrasound, and a pre-specified secondary endpoint for superior sensitivity for detecting small HCC lesions (≤ 4 cm).
“This landmark CLiMB study publication validates Helio Genomics’ leadership in delivering transformative, blood-based early detection that turns deadly surveillance gaps into lifesaving opportunities for patients with cirrhosis. These findings are particularly important for the millions of patients worldwide living with cirrhosis who need better, non-invasive tools to catch cancer before it progresses.”
HelioLiver™ demonstrated superior sensitivity to ultrasound for:
- overall HCC detection (47.8% vs. 28.3%), with 60% of the HCC cases at stage I;
- early-stage and small lesions (37.8% vs. 13.5% for lesions ≤ 4 cm, and 28.6% vs. 0% for lesions < 2 cm); and
- T1/stage 1 HCC (40.0% vs. 10.0%).
HelioLiver™ maintained statistical non-inferior specificity (87.6% vs. 93.9%) and showed higher sensitivity than the combination of ultrasound plus AFP (47.8% vs. 34.8%), with a comparable negative predictive value (NPV, 97.8% vs. 97.4%).
“The CLiMB study underscores the limitations of current ultrasound-based surveillance and the promise of this multi-analyte test in detecting HCC at earlier, more treatable stages. In the prospective CLiMB trial, the HelioLiver™ test showed superior performance compared to liver ultrasound, especially stage I HCC and tumors ≤ 2 cm, among patients with cirrhosis of diverse etiologies, with over half having obesity and/or MASLD/MASH — the group now fueling the sharp rise in HCC cases.”
“Reliable early detection for HCC is lacking, and the CLiMB trial results demonstrate that Helio’s test has tremendous potential for addressing a large, unmet medical need. Current imaging surveillance catches less than one-third of HCC cases and misses nearly all small, early-stage tumors. This multi-analyte test offers a convenient blood-based option to help close critical gaps in early detection.”
Liver cancer ranks among the fastest-rising causes of cancer-related deaths, with incidence rates tripling and mortality doubling since 1980.2 When identified early, the five-year survival rate soars to 70 percent.3 Only ~9% of cirrhosis patients receive recommended semiannual ultrasound, with pooled adherence rates as low as 24% overall.1,4 HelioLiver™ overcomes these challenges with its convenient, noninvasive blood-based approach. The test is now commercially available nationwide from Helio Genomics.
About Helio Genomics
Helio Genomics is a commercial-stage, AI-driven TechBio company revolutionizing diagnostics for early cancer detection and minimal residual disease monitoring. Its advanced multi-analyte blood-based platform harnesses machine learning and deep learning to detect cancer biomarkers, enabling clinicians and patients to respond decisively against cancer. Clinically validated in multicenter studies involving thousands of patients, Helio Genomics is expanding its commercial footprint. For more information, visit www.heliogenomics.com.
About HelioLiver™
HelioLiver™ is a blood-based test to aid in the detection of hepatocellular carcinoma (HCC). Combining cfDNA methylation patterns, protein biomarkers, and patient demographics using a proprietary AI algorithm, it provides an additional source of risk and disease signal at an early stage, even when ultrasound findings may be limited or not yet definitive — for individuals with risk factors for liver cancer due to cirrhosis from any cause, including chronic HBV or HCV infection, alcohol-associated liver disease, obesity, and MASLD/MASH.
1. Yeo YH, Hwang J, Jeong D, et al. Surveillance of patients with cirrhosis remains suboptimal in the United States. J Hepatol. 2021;75(4):856-864.
2. American Cancer Society: Liver Cancer, Fastest-Growing Cause of Cancer Death in the U.S. (2017).
3. UpToDate: Clinical features and diagnosis of HCC.
4. Wolf E, Rich NE, Marrero JA, Parikh ND, Singal AG. Use of Hepatocellular Carcinoma Surveillance in Patients With Cirrhosis: A Systematic Review and Meta-Analysis. Hepatology. 2021;73(2):713-725.
SOURCE Helio Genomics. Read the Journal of Hepatology publication. Media Contact: Danielle Fox, 413899@email4pr.com.