Himalaya Livline | Vol 6 | No. 4 | May–Aug 2023 | 9 Technologic Advances HelioLiver Test: A Multianalyte Blood Test for Early Detection of Hepatocellular Carcinoma The mortality rate in patients with hepatocellular carcinoma (HCC) has substantially increased over the past few decades due to delayed diagnosis (ie, usually diagnosed at a late noncurable stage). The performance of current HCC surveillance tests such as ultrasonography with or without serum a-fetoprotein (AFP) test is suboptimal in effective early tumor detection. Currently, liquid biopsies that assay the methylation of circulating cell–free DNA (cfDNA) released from cancer cells have been actively explored as a promising biomarker for sensitive detection of HCC at early stages. Further, by optimizing the cfDNA methylation panel, the HelioLiver test was designed for robust and accurate HCC detection. Performance Evaluation of the HelioLiver Test The HelioLiver test is a multianalyte blood test that combines cfDNA methylation markers with patient demographic information and clinically available HCC tumor markers. A prospective, blinded, multicenter phase 2 biomarker study was conducted to evaluate the performance of the HelioLiver test as an early detection marker of HCC. The study included 122 patients with HCC and 125 patients with a benign liver disease without HCC, in the test and control groups, respectively. Blood samples were collected from the patients to measure serum concentrations of AFP, Lens culinaris agglutininreactive AFP (AFP-L3%), and des-g-carboxy prothrombin (DCP), and to capture cfDNA methylation sequences. These sequences were included in a discovery methylated cell-free DNA (m-cfDNA) panel and further refined to generate a preliminary next-generation sequencing m-cfDNA panel. Finally, 28 gene (ie, 77 cytosine–guanine dinucleotide sites) m-cfDNA markers, 3 serum protein tumor markers (ie, AFP, AFP-L3%, and DCP), and patient demographics such as age and sex were combined to generate the results for the HelioLiver test. The primary end point was to compare the area under the receiver operating characteristic curve of the HelioLiver test with both AFP alone and the gender, age, AFP, AFP-L3%, and DCP (GALAD) score. The co-secondary end points were to compare the sensitivity and specificity of the HelioLiver test with both AFP alone and the GALAD score. In this study, the sensitivity of the HelioLiver test was found to be better than AFP, AFP-L3%, and DCP individually, and the GALAD score. The HelioLiver test, which incorporates components of the GALAD score, achieved improved performance over the GALAD score itself. The study confirmed that the HelioLiver test demonstrated superior sensitivity and similar specificity in detecting early-stage (1 and 2) HCC compared with clinically available tests. Thus, application of a blood test such as the HelioLiver test will enable easy and accurate HCC detection at early stages and will significantly improve treatment outcomes for a transformative reduction of HCC mortality. Source: Lin N, et al. Hepatol Commun. 2022;6(7):1753–1763. Disclaimer: The content in this section is for general information only, and holds no commercial interests.
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