Clinical Trial Multi-analyte Blood Test

Prior treatment

• Subject has previously been diagnosed with a primary liver cancer or a non-liver cancer that has metastasized
• Subject has previously submitted a blood sample to Helio Health (HELIO) through a separate clinical protocol
• Subject has any internal metallic device or fragment, including but not limited to: A pacemaker, artificial joint or valve, surgical clips, pins, plates, screws, wire mesh or shrapnel
• Subject received an abdominal ultrasound or diagnostic imaging by MRI or CT to image the liver within the past 5 months

Other illness

• The study investigator deems the subject's participation to be unsafe due to an underlying medical condition
• It is unsafe for the subject to receive an MRI contrast dye due to pregnancy or severe kidney disease

Other

• Subject is unable or unwilling to submit blood samples for testing, undergo ultrasound or undergo diagnostic imaging by multiphasic MRI with contrast as required for the Study Protocol
• Subject would not routinely be recommended for HCC surveillance

• Subject is age 21 to 84 (inclusive)
• Subject is able to read, comprehend and sign the Informed Consent Document
• Subject is willing and able to undergo liver cancer surveillance by ultrasound and the multi-analyte blood Test
• Subject is able and willing to undergo diagnostic imaging by multiphasic MRI with contrast according to the Study Protocol
• Subject has been diagnosed with liver cirrhosis by one or more of the following methods:
  • Clinical diagnosis by blood analytes (APRI ≥ 1.5 or Bonacini cirrhosis discriminant score ≥ 8 or Lok index \> 0.5)
  • Ultrasound and Elastography \> 12.5 kPa (Vibration-controlled transient elastography, Point shear wave elastography, Two-dimensional shear wave ultrasound and transient elastography or Magnetic Resonance Elastography)
  • Diagnostic imaging by CT or MRI (liver cirrhosis indicated on radiology report)
  • Liver biopsy (liver cirrhosis indicated on pathology report)