Landmark CLiMB Study Demonstrates Superior Sensitivity of HelioLiver™, a Multi-Analyte Blood Test, Over Ultrasound for Early Detection of Hepatocellular Carcinoma

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 titled, "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, as 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 inclusive of over 80,000 patients with cirrhosis¹.

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 directly compare the performance of HelioLiver™, a multi-analyte blood test combining cfDNA methylation patterns, serum protein markers, and demographic information to standard abdominal ultrasound for detection of HCC. Unlike many other studies, the CLiMB study included contemporaneous multiphasic MRI for all study participants as the gold standard for clinical truth (regarding the presence or absence of HCC). The HelioLiver™ test met two pre-specified, co-primary endpoints for superior sensitivity and non-inferior specificity compared to abdominal ultrasound for the detection of HCC. The HelioLiver test also met a pre-specified secondary endpoint for superior sensitivity for detecting small HCC lesions (less than or equal to 4 cm in diameter).

"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," said Bharat Tewarie, Chief Executive Officer of Helio Genomics. "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%) in this prospective trial, with 60% of the HCC cases at stage I.
• with even more striking advantages for early-stage and small lesions (37.8% vs. 13.5% for lesions ≤4 cm, and 28.6% vs. 0% for lesions <2 cm), and
• for 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 patients with cirrhosis," said Prof. Mindie H. Nguyen, Professor of Medicine (Gastroenterology, Hepatology and Liver Transplant) and, by courtesy, of Epidemiology and Population Health at Stanford University School of Medicine and a leading expert in liver cancer and Lead Principal Investigator for the CLiMB trial. "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 liver disease etiologies, with over half having either obesity and/or metabolic dysfunction-associated steatotic liver disease/metabolic dysfunction steatohepatitis (MASLD/MASH). This is 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," said Prof. Richard Van Etten, Director of the Chao Family Comprehensive Cancer Center at the University of California, Irvine and Chief Medical Advisor at Helio Genomics. "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 is emerging as a silent epidemic in the U.S., often going undetected until advanced stages due to the absence of early symptoms. It 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, driven by scheduling difficulties, transportation barriers, and lack of access^1,4. HelioLiver™ overcomes these challenges with its convenient and noninvasive blood-based approach, facilitating early detection when curative treatments are most effective. 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. For more information, visit www.heliogenomics.com.

Media Contact: Danielle Fox, [email protected], (360) 509-9527

About HelioLiver™ 
HelioLiver™ is a blood-based test to aid in the detection of hepatocellular carcinoma (HCC), the most common form of liver cancer. HelioLiver™ is designed to fit into routine liver cancer surveillance schedules with a simple blood draw. By combining cell-free DNA methylation patterns, protein biomarkers, and patient demographics using a proprietary AI algorithm, HelioLiver™ aims to provide an additional source of risk and disease signal at an early stage, even when ultrasound findings may be limited or not yet definitive. This simple blood draw addresses testing barriers, boosting early detection rates, and improving outcomes for individuals with risk factors for liver cancer due to liver cirrhosis from any cause, including chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, alcohol-associated liver disease (ALD), obesity, and metabolic dysfunction-associated steatotic liver disease (MASLD/MASH). Helio Genomics is expanding its commercial footprint to combat this pressing health challenge.

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. doi:10.1016/j.jhep.2021.04.042
² American Cancer Society Report Liver Cancer, Fastest-Growing Cause of Cancer Death in the U.S.
³ Up-To-Date.com: 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. doi:10.1002/hep.31309

SOURCE Helio Genomics