Mursla Bio has announced promising results from its multi-center clinical study, MEV01, evaluating the EvoLiver test for the surveillance of hepatocellular carcinoma (HCC) in high-risk, cirrhotic patients. The study, conducted in collaboration with institutions including University College London and Imperial College London, demonstrates the potential of EvoLiver to significantly improve early detection of liver cancer.
High Sensitivity and Specificity
The EvoLiver test, a dynamic biopsy-based blood test, leverages extracellular vesicle (EV) science to identify HCC biomarkers. The study results, based on 464 patient samples, showed that EvoLiver achieved 86% sensitivity and 88% specificity in detecting early-stage HCC. These results surpass existing surveillance techniques, such as ultrasound and alpha-fetoprotein testing, which often struggle to detect small tumors, especially in overweight patients.
Technology Behind EvoLiver
The EvoLiver test isolates organ-specific hepatocyte extracellular vesicles (h-EVs) from blood samples. This allows for the validation of a novel HCC biomarker signature comprised of fewer than 10 h-EV microRNAs and proteins. This pioneering platform distinguishes HCC with cirrhosis from non-cancerous cirrhosis.
Clinical and Economic Impact
The expanding population at risk of developing HCC is placing an increasing economic burden on healthcare systems. Current surveillance methods, including ultrasound, often have difficulties detecting small tumors. EvoLiver's low blood volume requirement and quick turnaround times support improved patient outcomes while streamlining disease management for clinicians and patients. According to Mursla Bio, earlier detection is critical to improving survival rates, as it enables access to effective treatments such as ablation, resection, or transplant.
Future Plans
Mursla Bio plans to publish the final MEV01 results in 2025. The company also intends to offer the test in the US as a Laboratory Developed Test (LDT) and conduct a larger study to secure FDA approval and broad reimbursement coverage. Dr Tomás Dias, Mursla Bio’s CSO, presented data from the study at AASLD’s The Liver Meeting in San Diego on November 17, 2024.
