Researchers said the blood test offers an earlier warning of hepatocellular carcinoma than current methods.
Recent research highlights the increased sensitivity and specificity of a blood test to detect hepatocellular carcinoma (HCC) in its earlier stages compared with visual monitoring.
Current HCC screening for at-risk patients is via ultrasound, with or without an α-fetoprotein (AFP) blood test.
The researchers indicated that, given the growing problem of liver cancer—more than 30,000 deaths are anticipated this year—improved detection at an earlier stage could enable faster access to curative therapies. Fewer than 30% of patients who should be screened for HCC are, largely due to several factors, including misinformation, costs, and scheduling or transportation challenges. Ultrasound has a 63% sensitivity rate for detecting HCC, and it drops in patients with cirrhosis, with nonalcoholic steatohepatitis, or those who are obese. The AFP blood test alone is even less robust.
The current study, published online in Clinical Gastroenterology and Hepatology, aimed to establish the algorithm and cutoff values for the blood test and to validate its performance. The multitarget HCC blood test (mt-HBT), called Oncoguard Liver, analyzes a panel of 3 DNA methylation markers (HOXA1, TSPYL5, and B3GALT6), AFP, and sex.
Study participants in the international, multicenter, case-control study had underlying cirrhosis or chronic hepatitis B virus (HBV) who were being watched for HCC and individuals with early-stage HCC who had not been treated.
For algorithm development, the study consisted of 136 HCC cases (60% with early-stage disease) and 404 controls, matched for age and liver disease etiology. The blood test showed 72% sensitivity for early-stage HCC at 88% specificity.
Test performance was validated in an independent group of 156 HCC cases (50% with early-stage disease) and 245 controls, and this showed an overall sensitivity of 88%, early-stage sensitivity of 82%, and specificity of 87%.
The researchers said the blood test was more sensitive than 2 other measures alone, AFP and one called GALAD, which is a composite of gender, age, AFP-L3, AFP, and des-gamma-carboxy prothrombin and is meant to be used to stratify risk.
The study had some limitations. The inclusion of controls in an earlier, broader sample collection may have been based in part on AFP level, which was less than 20 ng/mL, and individuals with higher AFP levels might not have been enrolled, potentially resulting in a higher specificity. In addition, the design of this study did not include the full range of patients who might be seen in the surveillance population. In addition, some control participants may have have had undetectable HCC at their initial imaging, although the researchers indicated that was unlikely.
Future research using this test will look at access and health care coverage issues, cost-effectiveness, and real-world results, the authors said.
The study was funded by Exact Sciences, which markets the test.
Chalasani NP, Porter K, Bhattacharya A, et al. Validation of a novel multi-target blood test shows high sensitivity to detect early-stage hepatocellular carcinoma. Clin Gastroenterol Hepatol. Published online August 9, 2021. doi:10.1016/j.cgh.2021.08.010