- Three independent clinical feasibility studies (case–control studies)
- Collaborations between Glycotest innovator (Anand Mehta; patient sample assays and data analysis) and clinical collaborators (patient samples)
- Patient samples collected under IRB-approved protocols
- Patient cohorts assembled by clinical collaborators
- Glycotest innovator blinded to clinical data until after samples were assayed
- Study 1 stratified by curable early stage HCC (T1 + T2) and AFP-negative disease (< 20 ng/mL)
- Study 2 stratified by HCC disease stage (curable HCC: T1; T2; T1 + T2)
- Study 3 stratified by curable early stage HCC (T1 + T2) and AFP-negative disease (< 20 ng/mL)
- Chronic hepatitis B patients (76% of Study 2 control patients) predominantly Asian
o No evidence of Western–Asian difference in these studies or published clinical data on individual biomarkers
T1: 1 lesion < 2 cm T2: 1 lesion 2–5 cm or ≤ 3 lesions < 3 cm
T2: 1 lesion 2–5 cm or ≤ 3 lesions < 3 cm