HELIO Liver Test Performance Study in China (HEPATIC)

Inclusion Criteria

• •The subject has provided informed consent to participate in the study
• •The subject is 18 to 75 years old (inclusive)
• •For subjects diagnosed with HCC, the subject must meet the following criteria:
• •The subject must have active HCC at the time of the blood draw
• •The subject has not undergone treatment for HCC
• •For subjects diagnosed with primary liver cancer, the subject has been recently diagnosed (within 3 months of enrollment) to have HCC by at least one of the following methods:
• •Subject has a ≥1 cm lesion that is indicated to be HCC by MRI or CT due to exhibiting arterial phase hyperenhancement in combination with washout appearance
• •Subject has a lesion of any size that is indicated to be HCC due to capsule appearance by 4 phase CT scan or multiphase contrast enhanced MRI
• •Subject has a biopsy that is positive for HCC
• •Diagnostic imaging by multiphasic MRI or CT indicates a suspicious lesion on the liver, which is subsequently confirmed to be HCC by another method (biopsy, or surgical pathology) within 3 months from the blood draw
• •For subjects without liver cancer, the subject is confirmed NOT to have liver cancer by at least one of the following methods within 3 months of the blood draw
• •Ultrasound result is negative for HCC or suspicious lesions
• •Diagnostic imaging by multiphasic MRI or CT clearly indicates the subject does not have HCC