Diagnostic performance of Liver FibraChek Dx©, a blood-based test for the non-invasive detection of liver cirrhosis and cancer

Abstract

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD), hepatic fibrosis, and cirrhosis are major risk factors for hepatocellular carcinoma (HCC), yet current blood-based diagnostic assays lack sufficient accuracy for routine clinical use. Identifying a non-invasive molecular signature that accurately detects liver disease could improve early diagnosis and monitoring. We hypothesized that the Liver FibraChek Dx^© serum assay could discriminate MASLD and HCC from healthy controls using a multiplex biomarker-based algorithm.

Aim: To evaluate the diagnostic performance of the Liver FibraChek Dx^© assay for detecting MASLD and HCC.

Methods: This was a prospective, single-center study conducted in a United States tertiary care setting. Serum samples were collected from 45 participants (14 MASLD, 19 HCC, 12 healthy controls) with liver histology confirmed by biopsy. The Liver FibraChek Dx^© algorithm integrates weighted values of aspartate aminotransferase, alanine aminotransferase, taurocholic acid, L-tyrosine, platelet count, and patient age to generate a risk score. Wilcoxon rank sum tests were used to assess associations with histologic diagnosis, and receiver operating characteristic (ROC) curves quantified diagnostic performance.

Results: Liver FibraChek Dx^© risk scores were significantly elevated in MASLD and HCC compared to controls (median: 6.92 ± 3.86 vs 3.61 ± 1.67, P < 0.001). The area under the ROC curve was 0.890 (95%CI: 0.776-1.000) for distinguishing diseased from healthy individuals. Sensitivity was 93.9%, specificity 75.0%, positive predictive value 91.1%, negative predictive value 81.8%, and overall accuracy 88.9%.

Conclusion: The Liver FibraChek Dx^© assay accurately detects liver disease and shows promise as a non-invasive tool for diagnosing and monitoring MASLD and HCC.

Keywords: Biomarkers; Cirrhosis; Fibrosis; Hepatocellular carcinoma; High pressure liquid chromatography; Metabolic dysfunction-associated steatotic liver disease; Metabolomics; Multiplex; Peripheral blood.

Figure 1

Risk analysis for liver disease. A comprehensive risk score is calculated using the levels of 5 biomarkers [serum L-tyrosine, taurocholic acid (by Liver FibraChek Dx^©), alanine aminotransferase, aspartate aminotransferase, and platelet count] (by standard laboratory hematological assessments), and patient age. Risk scores are categorized into 4 quartile groups, with 0.0 indicating low risk of hepatic disease and 1.0 indicating maximum risk of serious liver disease.

Figure 2

Liver assay receiver operating curve characteristics. The high likelihood of identifying metabolic dysfunction-associated steatotic liver disease using the Liver FibraChek Dx^© + algorithm combination was demonstrated by an area under the receiver operating curve of 0.890 (95%CI: 0.776-1.000). The Liver FibraChek Dx^© + algorithm combination. ROC: Receiver operating curve.