Subjects age 18 years and older who are at an increased risk for HCC and for whom HCC surveillance is appropriate, including subjects with cirrhosis or non-cirrhotic subjects with Hepatitis B. Approximately 3,000 subjects are expected to be enrolled, comprised of approximately 2,222 ultrasound surveillance subjects and 778 subjects under surveillance with CT/MRI.
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.