ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk

Inclusion Criteria:

1. Be 18 years of age or older.

2. Understand the study procedures, be able to provide written informed consent toparticipate in the study, and have authorization for release of data, includingpersonal health data and images, to the study Investigator, Sponsor, and regulatoryauthorities.

3. Present for surveillance imaging due to increased risk for HCC, including either:

4. Diagnosis of cirrhosis based on at least one of the following:

• Histology from a liver biopsy.
• Ultrasound, CT, or MRI showing a cirrhotic liver combined with portalhypertension (as evidenced by the presence of intra-abdominal varices, orrecanalized umbilical vein, or ascites or splenomegaly or thrombocytopenia [defined as Platelet count < 150,000]). The imaging results must have beenobtained within 5 years of study enrollment.
• Liver stiffness ≥4.71 kilopascal (kPa) by Magnetic Resonance (MR)elastography or ≥12.1 kPa by vibration controlled transient elastography.
• Presence of varices on endoscopy or imaging and presence of a chronicliver disease. OR

2. Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for >6 months)

Exclusion Criteria:

1. Known cancer diagnosis (including active malignancy) within the past 5 years exceptfor nonmelanoma skin cancer.

2. Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.

3. Known Child-Pugh class C liver function at the time of enrollment, except for thoseon the waiting list for transplant.

4. Solid liver nodule >1 cm by ultrasound or elevated Alpha-fetoprotein (AFP) (>100ng/mL) in 12 months preceding the qualifying surveillance imaging visit withoutsubsequent documentation of HCC negative or LIRADS 1 (Liver Imaging Reporting andData System) by diagnostic CT/MRI.

5. Females known to be pregnant at the time of enrollment.

6. Illness that the Investigator believes poses a significant risk of mortality duringthe study period, including but not limited to

7. Congestive heart failure with ejection fraction <50%

8. Chronic lung disease requiring supplemental oxygen.

9. History of recent stroke.

10. Sustained virologic response (SVR) for Hepatitis C Virus (HCV) (undetectable HCV RNA 12 to 24 weeks after completion of antiviral therapy) for >10 years prior toenrollment.

11. Not able to have IV contrast for CT or MRI due to

12. Allergy to IV contrast and unwilling or unable to receive IV contrast afterpre-medication.

13. Estimated glomerular filtration rate <35 mL/min and not on hemodialysis.