Multi-analyte Blood Test Clinical Trial

Inclusion Criteria:

• Age 18 years or older.

• Males and Females.

• Having cirrhosis or meeting the AASLD guidelines for HCC

• surveillance.

• Clinically diagnosed with HCC or negative for HCC following disease

• surveillance.

• HCC positive Group: Subject has a recent (within 6 months of enrollment) clinicallydiagnosed, untreated hepatocellular carcinoma as defined by at least one ≥1 cmlesion exhibiting arterial phase hyperenhancement in combination with washoutappearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI orbiopsy is positive for HCC.

• HCC negative Group: Non-cancer, at-risk subjects with chronic liver diseaseundergoing routine imaging surveillance for HCC, where the definitive lack of HCCwithin 3 months prior to enrollment has been verified by negative imaging, for HCC.No more than 200 subjects without cirrhosis can be enrolled in this group.

• Sub-Group 1 (approximately 450 subjects) - negative by CT or MRI (No lesion, LR-1 orLR-2)

• Sub-Group 2 (approximately 450 subjects) - negative by ultrasound

Exclusion Criteria:

• Subjects that are unwilling or unable to sign the Informed Consent Form will beexcluded.

• Known cancer diagnosis of a cancer other than HCC within the past 5 years (with theexceptions of basal cell or squamous cell skin cancers).

• Chemotherapy and/or radiation therapy within 5 years prior to enrollment/samplecollection.

• Prior or current treatment with sorafenib, regorafenib, or other treatment indicatedfor HCC.

• Prior treatment with a DNA methyltransferase inhibitor such as with Vidaza (azacitidine) or Dacogen (decitabine)

• Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery,ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or othertreatment indicated for HCC).

• IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.

• Less than 3 days between fine needle aspiration (FNA) of target pathology and bloodcollection.

• Less than 7 days between biopsy (other than FNA) of target pathology and bloodcollection.

• Any condition the Investigator believes would interfere with his or her ability toprovide informed consent, comply with the study protocol, which might confound theinterpretation of the study results or put the person at undue risk.

• For HCC negative subjects, patients with a prior diagnosis of HCC are also excluded.

• Subjects that are pregnant will be exclude