Seravue Validation Study for Hepatocellular Carcinoma (HCC) Diagnosis

Currently, ultrasound with or without AFP is the standard of care when it comes to surveillance for HCC in high-risk populations. While ultrasound is non-invasive and plays a critical role in detecting HCC, it is operator-dependent, inconvenient, and may have access issues in low-resource settings. Most critically, ultrasound is not sensitive enough to detect or confirm HCC in its most critical early stages, where treatment options are most effective and result in the best patient outcomes. AFP on the other hand, suffers from poor sensitivity and specificity generally, and its performance is insufficient for use as a surveillance tool. There remains a clear unmet need for a blood test that is sensitive enough to detect HCC in its early stages while being cost-effective and accessible for use as a surveillance tool.

The investigators have previously demonstrated that serum liver cancer-secreted serine protease inhibitor Kazal (LC-SPIK) can reliably detect early HCC in addition to differentiating between it and other liver diseases. This study seeks to test the performance of the Seravue (LC-SPIK) device alone or in combination with other HCC diagnostic tests as a tool for HCC surveillance in diverse patient populations and clinical settings.