Real-world evidence on early detection of hepatocellular carcinoma, one case at a time.
Liver cancer is one of the few cancers in the United States where both incidence and mortality are still rising. Detected early, it is treatable, and five-year survival for early-stage HCC is greater than 70% (Llovet et al., Nat Rev Dis Primers 2021, as cited in the CLiMB publication). Detected late, median survival falls to approximately 1.0 to 1.5 years. The gap between those two outcomes is not a gap in what medicine knows. It is a gap in what gets detected, and when.
This case series exists to make that gap concrete. Each entry documents a single clinical situation, what conventional surveillance showed, what the HelioLiver Dx test showed, and what the published evidence says about how often that situation occurs. The cases are educational. They are not promotional, and they are not a substitute for clinical judgment.
Real-world, de-identified cases from clinical practice, shared for physician education. Individual patient outcomes vary, and clinical decisions should always be based on the complete clinical picture.
Routine surveillance was clean. AFP normal, ultrasound negative, MRI negative. The HelioLiver test was not. Six months later, imaging found a 10 × 9 mm mass.
Read the caseStandard abdominal ultrasound: no lesion detected. The HelioLiver® blood test returned positive. Follow-up MRI identified an 8 mm hepatocellular carcinoma (HCC), stage T1, while still within the curative treatment window.
Read the caseCLiMB was a prospective, blinded, multicenter validation study across 42 clinical sites in the United States, with 1,268 evaluable patients with cirrhosis, published in the Journal of Hepatology in 2026. Every participant received the HelioLiver Dx test, an abdominal ultrasound, and a multiphasic MRI, which served as the reference standard. Each case below is a cohort from that trial, not an individual patient.
In the smallest lesions in the trial, ultrasound sensitivity was 0%. The HelioLiver Dx test detected 6 of 21.
Read the caseAmong 30 participants with T1 tumors, the HelioLiver Dx test detected 40.0% compared with 10.0% for ultrasound alone.
Read the caseEighty percent of CLiMB participants were enrolled at community-based centers, the same setting where documented ultrasound adherence falls to 8.8%.
Read the caseHalf of the HCC cases in CLiMB had MASLD, and 55% of the study population was obese. Across every etiology of cirrhosis evaluated, the HelioLiver Dx test showed a higher sensitivity than the comparator modalities.
Read the caseFemale participants with HCC had an average largest lesion of 2.5 cm compared with 3.3 cm in men. Sensitivity was lower across all testing modalities.
Read the caseCLiMB was a cross-sectional, prospective, blinded, multicenter validation study conducted across 42 clinical sites in the United States, evaluating the HelioLiver Dx test against abdominal ultrasound for the detection of hepatocellular carcinoma in adults with cirrhosis. Multiphasic MRI served as the reference standard. The HelioLiver Dx test met prespecified co-primary endpoints for superior sensitivity and non-inferior specificity compared to ultrasound.
Enrolled vs. evaluable. A total of 1,556 patients were enrolled in the prospective CLiMB study and assigned to the validation cohort, of whom 1,285 completed the initial visit. At the 6-month follow-up visit, 17 participants were lost to follow-up and were excluded from analysis. Only participants with valid results from the HelioLiver Dx test, ultrasound, and multiphasic MRI were considered evaluable. A total of 1,268 participants (81.5%) were evaluable, including 46 participants with HCC and 1,222 participants without HCC. Every performance figure in this series is calculated on that evaluable population. Published in the Journal of Hepatology, 2026. ClinicalTrials.gov identifier NCT03694600.
Each new case is published first on LinkedIn and archived here in full.