A Multi-Analyte cfDNA-based Blood Test for Early Detection of Hepatocellular Carcinoma
A blood test detects liver cancer in high-risk patients better than ultrasound, especially for small tumors doctors typically miss, potentially catching more cancers early.
This first blinded, multicenter, prospective validation study (n=1,268) of a multi-analyte cfDNA blood test (HelioLiver Dx) for HCC detection in cirrhosis demonstrated superior sensitivity over standard ultrasound, particularly for small lesions ≤2 cm where ultrasound failed to detect any cases. The availability of a more sensitive, accessible blood-based test could transform HCC surveillance in high-risk populations by reducing barriers to screening and improving early detection rates.
What the study was
- Study design
- Cross-sectional, prospective, blinded, multicenter validation study
- Population
- Adults with cirrhosis at high risk for HCC; multicenter US cohort
- Sample size
- 1268
- Category
- Early Detection
- Maturity
- Validated
- Journal
- Journal of Hepatology
Why it surfaced
First blinded multicenter prospective validation of a cfDNA blood test for HCC. Directly addresses unmet need for more sensitive HCC surveillance in cirrhosis. Results clinically significant: 28.6% vs 0% sensitivity for small HCC ≤2cm is substantial. Published J Hepatol. NCT03694600.
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