A multi-analyte cell-free DNA-based blood test for early detection of hepatocellular carcinoma.

Autor: Lin N; The Third Affiliated Hospital of Sun Yat-sen UniversityGuangzhouChina., Lin Y; The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhouChina., Xu J; Helio Health, Inc.IrvineCaliforniaUSA., Liu D; Laboratory for Advanced Medicine, Inc.BeijingChina., Li D; Guangzhou Youze Biological Pharmaceutical Technology Company LtdGuangzhouGuangdong ProvinceChina., Meng H; The Third Affiliated Hospital of Sun Yat-sen UniversityGuangzhouChina., Gallant MA; Helio Health, Inc.IrvineCaliforniaUSA., Kubota N; Department of Internal MedicineSimmons Comprehensive Cancer CenterUniversity of Texas Southwestern Medical CenterDallasTexasUSA., Roy D; Helio Health, Inc.IrvineCaliforniaUSA., Li JS; Division of Computational BiomedicineDepartment of Biological ChemistrySchool of MedicineUniversity of CaliforniaIrvineCaliforniaUSA., Gorospe EC; Texas Gastro ResearchEl PasoTexasUSA., Sherman M; University Health NetworkTorontoOntarioCanada., Gish RG; Hepatitis B FoundationDoylestownPennsylvaniaUSA., Abou-Alfa GK; Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUSA., Nguyen MH; Division of Gastroenterology and Hepatology and Department of Epidemiology and Population HealthStanford University Medical CenterStanfordCaliforniaUSA., Taggart DJ; Helio Health, Inc.IrvineCaliforniaUSA., Van Etten RA; Department of MedicineChao Family Comprehensive Cancer CenterUniversity of CaliforniaIrvineCaliforniaUSA., Hoshida Y; Department of Internal MedicineSimmons Comprehensive Cancer CenterUniversity of Texas Southwestern Medical CenterDallasTexasUSA., Li W; Division of Computational BiomedicineDepartment of Biological ChemistrySchool of MedicineUniversity of CaliforniaIrvineCaliforniaUSA.
Jazyk: angličtina
Zdroj: Hepatology communications [Hepatol Commun] 2022 Jul; Vol. 6 (7), pp. 1753-1763. Date of Electronic Publication: 2022 Mar 03.
DOI: 10.1002/hep4.1918
Abstrakt: The limited performance of guideline-recommended abdominal ultrasound and serum alpha-fetoprotein (AFP) highlights the urgent, unmet need for new biomarkers for more accurate detection of early hepatocellular carcinoma (HCC). To this end, we have conducted a prospective clinical validation study to evaluate the performance of the HelioLiver Test, a multi-analyte blood test combining cell-free DNA methylation patterns, clinical variables, and protein tumor markers. A blinded, multicenter validation study was performed with 247 subjects, including 122 subjects with HCC and 125 control subjects with chronic liver disease. The performance of the HelioLiver Test was compared with AFP and the GALAD score as established HCC surveillance blood tests. The performance of the HelioLiver Test (area under the receiver operating characteristic curve [AUROC] = 0.944) was superior to both AFP (AUROC = 0.851; p < 0.0001) and GALAD (AUROC = 0.899; p < 0.0001). Using a prespecified diagnostic algorithm, the HelioLiver Test showed sensitivities of 85% (95% confidence interval [CI], 78%-90%) for HCC of any stage and 76% (95% CI, 60%-87%) for early stage (American Joint Committee on Cancer [AJCC] I and II) HCC. In contrast, AFP (≥20 ng/mL) alone and the GALAD score (≥-0.63) showed lower sensitivities of 62% (95% CI, 54%-70%) and 75% (95% CI, 67%-82%) for HCC overall, and 57% (95% CI, 40%-71%) and 65% (95% CI, 49%-79%) for early stage (AJCC I and II) HCC, respectively. The specificities of the HelioLiver Test (91%; 95% CI, 85%-95%), AFP (97%; 95% CI, 92%-99%), and the GALAD score (94%; 95% CI, 88%-97%) were similar for control subjects. The HelioLiver Test showed superior performance for HCC detection compared to with both AFP and the GALAD score and warrants further evaluation in HCC surveillance settings.
(© 2022 The Authors. Hepatology Communications published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases.)
Databáze: MEDLINE
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