IRVINE, Calif., May 6, 2026
Helio Genomics announced publication of landmark clinical data demonstrating that its HelioLiver™ multi-analyte blood test achieved superior sensitivity compared with standard abdominal ultrasound for the early detection of hepatocellular carcinoma (HCC) in patients with cirrhosis. The findings, published in the Journal of Hepatology, come from the pivotal CLiMB clinical trial, the largest completed prospective multicenter U.S. study evaluating a liquid biopsy test for liver cancer detection.
The study positions HelioLiver™ as a potentially transformative advancement in AI-powered liquid biopsy diagnostics and early cancer detection. Researchers reported that the blood-based test demonstrated significantly higher sensitivity than ultrasound across multiple key endpoints, particularly in identifying early-stage liver tumors and small lesions that are frequently missed by conventional imaging surveillance methods.
CLiMB Study Demonstrates Strong Diagnostic Performance
The CLiMB trial enrolled 1,968 patients with cirrhosis across 42 clinical sites throughout the United States, including 1,556 individuals assigned to the validation cohort directly comparing HelioLiver™ against standard abdominal ultrasound for HCC detection. The study incorporated multiphasic MRI imaging for all participants as the clinical gold standard, strengthening the accuracy and reliability of the findings.
According to Helio Genomics, the HelioLiver™ assay successfully met both pre-specified co-primary endpoints by demonstrating superior sensitivity and non-inferior specificity compared with ultrasound. The blood test achieved an overall HCC detection sensitivity of 47.8% versus 28.3% for ultrasound, representing a substantial improvement in cancer identification among high-risk patients with cirrhosis.
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Researchers highlighted even more dramatic performance differences in detecting early-stage and smaller tumors. For lesions measuring less than or equal to four centimeters, the HelioLiver™ test achieved sensitivity of 37.8% compared with 13.5% for ultrasound. For tumors smaller than two centimeters, the assay detected 28.6% of cases while ultrasound detected none. The test also demonstrated strong performance in identifying Stage I hepatocellular carcinoma, detecting 40% of cases compared with only 10% identified through ultrasound screening.
The blood-based platform combines cell-free DNA methylation patterns, serum protein biomarkers, and patient demographic data using proprietary artificial intelligence algorithms to generate predictive cancer detection signals. Helio Genomics stated that the multi-analyte approach enables more sensitive identification of cancer-associated biological changes before tumors become more advanced and difficult to treat.
Liver Cancer Detection Remains a Major Clinical Challenge
Hepatocellular carcinoma is the most common form of liver cancer and remains one of the fastest-rising causes of cancer-related deaths globally. Experts note that liver cancer is frequently diagnosed at advanced stages because many patients experience few or no symptoms during early disease progression.
Current surveillance approaches rely heavily on semiannual ultrasound imaging for patients with cirrhosis, but adherence remains poor due to scheduling challenges, limited healthcare access, transportation barriers, and inconsistent imaging quality. According to data cited in the study, only approximately 9% of cirrhosis patients in the United States consistently receive recommended ultrasound surveillance.
Investigators believe HelioLiver™ could help address these gaps by providing a convenient, noninvasive blood-based testing alternative that may improve screening participation and facilitate earlier cancer detection. Early diagnosis is particularly critical in HCC because five-year survival rates can increase dramatically when tumors are identified before progression to advanced disease stages. The study also included large numbers of patients with obesity and metabolic dysfunction-associated steatotic liver disease (MASLD/MASH), conditions increasingly driving rising liver cancer incidence worldwide.
Helio Genomics Expands AI-Driven Cancer Diagnostics
Helio Genomics described the publication as an important validation of its AI-powered TechBio platform focused on early cancer detection and minimal residual disease monitoring. The company’s technology uses machine learning and deep learning algorithms to analyze complex biological signals derived from blood samples, enabling noninvasive cancer screening and risk stratification.
The HelioLiver™ test is now commercially available nationwide and is designed for individuals with cirrhosis caused by hepatitis B virus, hepatitis C virus, alcohol-associated liver disease, obesity, and metabolic dysfunction-associated fatty liver disease.
Industry analysts believe multi-analyte liquid biopsy platforms could become increasingly important in future oncology screening programs as healthcare systems seek scalable, minimally invasive approaches capable of improving early cancer detection and patient outcomes.
Source: Helio Genomics press release
