Products

HB miRDx™

EarlyHCC Kit

HCC Diagnostics Using miRNA Biomarkers

Principle

▲ Age-Standardized Rate (World) per 100 000, Incidence and Mortality, Both sexes, in 2022

    WHO reports that Liver Cancer has the fourth highest mortality rate in the world in 2022. The issue with cancer diagnostics is that current tests are effective after considerable disease progression and are either low in accuracy, costly or highly invasive.

Therefore, to reduce the Case Fatality Rate (CFR), a minimally invasive molecular diagnostic method that can accurately detect cancer in its early stages (1-2 stages) is essential.

HB miRDx™ EarlyHCC Kit is a reverse transcription RT-qPCR kit that detects circulating microRNA biomarkers for early stage (1~2) to late stage(3~4) HCC from blood.

IVD

Clinical Trial Status

hcc_data

HB miRDx™ EarlyHCC Kit has completed Research Clinical Trials (RCT) and two Exploratory Clinical Trials (ECT) with approximately 500 clinical samples for an overall accuracy of 95.4%, sensitivity of 94.1% and specificity of 96.2%. The kit has a sensitivity of 89.5% for Stage 1~2, and 100% for Stage 3~4 liver cancer which demonstrates its potential as a widely utilized early liver cancer screening kit via liquid biopsy of blood.