HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC): Marker Performance Validation and Technical Development Study

• Men or women age 18 years or older;

• Able to read, understand and sign informed consent to participate in study;

• Willing and able to provide written informed consent;

• Willing and able to meet all study requirements and undergo venipuncture to provide blood samples;

• Child-Pugh Score of A or B.

⁃ Group 1:

⁃ • Diagnosis of cirrhosis and no HCC confirmed by abdominal contrast-enhanced MRI or CT study performed \< 90 days prior to the date of consent or an MRI performed ≤ 45 days after Visit 1. If lesions are present, a LI-RADS score of LR-1 or LR-2.

⁃ Group 2:

⁃ • Diagnosis of HCC confirmed by abdominal contrast-enhanced MRI or CT study performed \< 90 days prior to the date of consent or an MRI performed ≤ 45 days after Visit 1 with LI-RADS score of LR-5 and/or biopsy with histopathology.