CLINICAL DATA

Clinical Feasibility Studies—Head-to-head Comparison of the Glycotest HCC Panel to AFP

  • 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 

  • Additional information available in supplementary document 

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

HCC Panel—First Clinical Study

Performance Superior to AFP for the Discrimination Of Early-stage and AFP-negative HCC from Cirrhosis 

All: HCC (N=115) vs. cirrhosis (N=93)
Early-stage: HCC UNOS stage T1/T2 (N=69) vs. cirrhosis (N=93)
AFP ‒ (< 20 ng/mL): HCC (N=39) vs. cirrhosis (N=84)
Early-stage AND AFP ‒: HCC (N=29) vs. cirrhosis (N=84)
HCC Etiology (%): HCV (61); HBV (6); Other (33)
Cirrhosis Etiology (%): HCV (48); HBV (10); Other (42)

HCC Panel—Second Clinical Study

Independent Confirmation of Performance Superior to AFP for Detecting Early-stage HCC 

All: HCC (N=93) vs. chronic liver disease (N=34)
HCC stage: T1 N=32; T2 N=21; T3-4 N=20; unknown stage N=20
Chronic liver disease: cirrhosis N=9; HBV N=22; HCV N=2; ALD N=1

HCC Panel—Third Clinical Study

Performance Superior to AFP for the Discrimination Of Early-stage and AFP-negative HCC from non-HCC Controls 

  • Entire Cohort 

o HCC cases N = 75; non-HCC controls N = 74 o HCC Panel AUROC = 0.97 (95% CI 0.94 – 1.00); 93% sensitivity @ 92% specificity o AFP AUROC = 0.88 (95% CI 0.83 – 0.94); 71% sensitivity @ 92% specificity 

  • Early-stage Cohort (T1 + T2) 

o HCC cases N = 24; non-HCC controls N = 74 o HCC Panel AUROC = 0.96 (95% CI 0.91 – 1.00); 88% sensitivity @ 91% specificity o AFP Panel AUROC = 0.87 (95% CI 0.77 – 0.97); 75% sensitivity @ 91% specificity o The HCC Panel identified 78% of the HCC patients missed by AFP 

  • AFP-negative Cohort (AFP < 20 ng/mL) 

o HCC cases N = 29; non-HCC controls N = 72 o HCC Panel AUROC = 0.93 (95% CI 0.85 – 1.00); 86% sensitivity @ 90% specificity o AFP AUROC = 0.73 (95% CI 0.62 – 0.83); 34% sensitivity @ 90% specificity o The HCC Panel identified 86% of the HCC patients missed by AFP 

KEY FEATURES

- Exploits unique disease signal chemistry (glycoprotein fucosylation) present in liver cancers and fibrosis-cirrhosis but absent in healthy individuals

- Incorporated into highly promising biomarker panels

- Focused on the detection of potentially curable early-stage disease

- May outperform currently available serum biomarkers, such as AFP

- Targeting the worldwide liver cancer threat that kills more than 700,000 people annually and is the fastest growing cause of cancer death in the US

GLYCOTEST PRESENTATION

A New Paradigm for Early Diagnosis and Surveillance For Liver Cancer

Clinical Data | Glycotest Diagnostics