HelioLiver blood test shows higher sensitivity than ultrasound for early hepatocellular carcinoma in the CLiMB trial

In the CLiMB trial, HelioLiver detected hepatocellular carcinoma (HCC) with an overall sensitivity of 47.8% versus 28.3% for abdominal ultrasound, with 60% of the HCC cases at stage I. For T1/stage 1 HCC the figures were 40.0% versus 10.0%, for lesions of 4 cm or smaller 37.8% versus 13.5%, and for lesions under 2 cm 28.6% versus 0%. Specificity was 87.6% versus 93.9%, which Helio Genomics describes as statistically non-inferior. HelioLiver also showed higher sensitivity than ultrasound plus AFP (47.8% vs. 34.8%), with a comparable negative predictive value (97.8% vs. 97.4%). Prof. Richard Van Etten, Chief Medical Advisor at Helio Genomics, said: "Current imaging surveillance catches less than one-third of HCC cases and misses nearly all small, early-stage tumors." Helio Genomics announced the results on May 6, 2026, with publication in the Journal of Hepatology of a peer-reviewed article titled "A Multi-Analyte cfDNA-based Blood Test for Early Detection of Hepatocellular Carcinoma." The release notes that liver ultrasound surveillance is 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 with cirrhosis. CLiMB is described as 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 that directly compared HelioLiver with standard abdominal ultrasound. Contemporaneous multiphasic MRI for all participants served as the gold standard for the presence or absence of HCC. HelioLiver met two pre-specified co-primary endpoints, superior sensitivity and non-inferior specificity compared with ultrasound, and a pre-specified secondary endpoint for superior sensitivity in detecting small HCC lesions of 4 cm or smaller. HelioLiver is a multi-analyte noninvasive blood test that combines cfDNA methylation patterns, serum protein markers and demographic information using a proprietary AI algorithm. The release states that the test is now commercially available nationwide from Helio Genomics.