HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

• 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.

Exclusion Criteria:

Both Groups:

• Child-Pugh Score of C;
• Subject has undergone a colonoscopy, endoscopy or other invasive diagnostic procedure (other than venipuncture) during the 10 days prior to providing a blood sample for this study;
• Pregnancy;
• Breastfeeding;
• Currently undergoing dialysis;
• Currently receiving investigational treatments of any type;
• History of receiving any drug therapy, surgery or liver transplant for the treatment of HCC;
• Diagnosis of any non-HCC cancer (other than non-melanoma skin cancer) within past 5 years and/or currently undergoing treatment for any cancer;
• Any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would be mean participation in the study would be contraindicated.