Case-Control Study of the Glycotest™ HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma

Inclusion Criteria:

Cases

   1. Males and females ages 18 years or older.

   2. Treatment-naïve HCC as defined by LI-RADS (Liver Imaging Reporting and Data System)
   LR-5 or OPTN (Organ Procurement and Transplantation Network) 5 CT or MRI criteria (all
   lesions must exhibit arterial phase hyper-enhancement), or histologic evidence.

   3. Early-stage HCC defined by single lesion ≤ 5 cm or ≤ 3 lesions ≤ 3 cm determined at
   enrollment or within 100 days prior without vascular invasion.

   4. Cirrhosis based on serum biomarkers (FibroSure®/FibroTest > 0.74, APRI (AST to
   Platelet Ratio Index) > 2, or FIB-4 (Fibrosis-4) > 3.25), histology, imaging,
   elastography, or clinical evidence of portal hypertension in the setting of known
   chronic liver disease.

   5. Child-Pugh score A-B8.

   6. Subject must be able to understand and provide informed consent.

Controls

   1. Males and females ages 18 or older.

   2. Cirrhosis based on serum biomarkers (FibroSure®/FibroTest > 0.74, APRI > 2, or FIB-4 >
   3.25), histology, imaging, elastography, or clinical evidence of portal hypertension
   in the setting of known chronic liver disease.

   3. Evidence of the absence of a solid hepatic mass, suspicious for HCC, at enrollment or
   within 100 days prior based on one of the following:

      1. Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR

      2. Negative abdominal US at both screening/baseline visit AND 6-month follow-up
      visit, OR

      3. Negative abdominal US at screening/baseline visit AND negative multiphase CT scan
      or MRI with contrast at 6-month or earlier follow-up visit.

   4. Child-Pugh score A-B8.

   5. Subject must be able to understand and provide informed consent.

Exclusion Criteria:

Cases

   1. Uncontrolled ascites.

   2. Uncontrolled encephalopathy.

   3. History of liver transplant.

   4. Diagnosis of active malignancy or history of active malignancy within 5 years prior to
   enrollment, including mixed HCC-CCA (cholangiocarcinoma). If previously diagnosed with
   malignancy, subject must be in remission for at least 5 years prior to enrollment.
   Prior history of HCC, including resection of HCC at any time, is excluded.

   5. Prior treatment of tumor.

   6. Any significant non-liver-related medical condition in which expected survival is less
   than 1 year.

Controls

   1. Imaging evidence of solid hepatic mass, suspicious for HCC, including lesions meeting
   LI-RADS LR-3 or LR-4, OPTN-3 or OPTN-4, or LI-RADS LR-M criteria.

   2. Uncontrolled ascites.

   3. History of liver transplantation.

   4. Uncontrolled encephalopathy.

   5. Diagnosis of active malignancy or history of active malignancy within 5 years prior to
   enrollment (if previously diagnosed with malignancy, subject must be in remission for
   at least 5 years prior to enrollment). History of HCC including resection of HCC at
   any time, is excluded.

   6. Any significant non-liver-related medical condition in which expected survival is less
   than 1 year.