HELIO Liver Test Performance Study in China (HEPATIC)

Prior treatment

• Subject has previously been diagnosed with a primary liver cancer
  • Subject has previously received any treatment for HCC prior to enrollment/blood sample collection, including: surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC
  • Subject has undergone prior or current treatment for HCC with sorafenib, regorafenib, or other treatment indicated for HCC.
  • Subject has received a cancer diagnosis within the past 5 years for any cancer (with the exceptions of basal cell or squamous cell skin cancers).
  • Subject has received treatment for any cancer, including chemotherapy and/or radiation therapy, within 5 years prior to enrollment/sample collection.
  • Subject have received IV contrast dye (for multiphasic CT or MRI) within 1 day \[or 24 hours\] of blood collection.
  • Subject has undergone fine needle aspiration (FNA) of target pathology withing 3 days prior to blood collection.
  • Subject has undergone a biopsy (other than FNA) of target pathology withing 7 days prior to blood collection.

• 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