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

Exclusion Criteria

• •1. Known cancer diagnosis (including active malignancy) within the past 5 years except for 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 those on the waiting list for transplant.
• •4. Solid liver nodule \>1 cm by ultrasound or elevated Alpha-fetoprotein (AFP) (\>100 ng/mL) in 12 months preceding the qualifying surveillance imaging visit without subsequent documentation of HCC negative or LIRADS 1 (Liver Imaging Reporting and Data 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 during the study period, including but not limited to
• •1. Congestive heart failure with ejection fraction \<50%
• •2. Chronic lung disease requiring supplemental oxygen.
• •3. History of recent stroke.
• •7. 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 to enrollment.
• •8. Not able to have IV contrast for CT or MRI due to
• •1. Allergy to IV contrast and unwilling or unable to receive IV contrast after pre-medication.
• •2. Estimated glomerular filtration rate \<35 mL/min and not on hemodialysis.