Promising Clinical Study Findings for EvoLiver™
Mursla Bio, a leader in Extracellular Vesicle (EV) science, has unveiled encouraging results from its multi-center clinical study, MEV01, aimed at revolutionizing liver cancer detection. The study investigates the company’s EvoLiver™ blood test, a dynamic biopsy-based approach designed to improve surveillance of hepatocyte carcinoma (HCC) among high-risk patients with cirrhosis. The EvoLiver test demonstrated 86% sensitivity for early-stage HCC detection and 88% specificity, significantly outperforming traditional surveillance methods like ultrasound and alpha-fetoprotein testing.
The findings are based on 464 patient samples, primarily collected prospectively, from western populations with risk factors such as fatty liver disease, alcoholic liver disease, and hepatitis. EvoLiver isolates organ-specific hepatocyte extracellular vesicles (h-EVs) from blood samples to validate a novel biomarker signature comprising fewer than ten h-EV microRNAs and proteins. This innovation marks the establishment of the first EV multi-omics biomarker signature for HCC, offering a transformative step forward in liver cancer detection.
Addressing Critical Challenges in HCC Surveillance
HCC remains one of the most challenging cancers to detect early, particularly in overweight patients or those with complex liver disease etiologies. Existing surveillance techniques, such as ultrasounds, often struggle to identify small tumors, leading to delayed diagnoses and limited treatment options. Mursla Bio’s EvoLiver test aims to address these challenges by offering a blood-based solution that is both affordable and highly accurate.
EvoLiver’s groundbreaking platform isolates h-EVs and uses advanced multiomics techniques to differentiate between cancerous cirrhosis and non-cancerous cirrhosis. Its minimal blood volume requirement, rapid processing times, and high accuracy promise better patient outcomes and streamlined disease management for clinicians. Mursla Bio envisions EvoLiver as a tool that reduces the economic burden on healthcare systems while significantly improving early detection rates.
Next Steps and Future Implications
Mursla Bio has ambitious plans for the future of EvoLiver. The company aims to publish the final MEV01 study results in 2025, offer the test in the United States as a Laboratory Developed Test (LDT), and initiate a larger study to secure FDA approval and reimbursement coverage. These steps will solidify EvoLiver’s role in transforming HCC surveillance and treatment pathways.
Dr. Tomás Dias, Chief Scientific Officer of Mursla Bio, presented the study’s findings at The Liver Meeting hosted by the American Association for the Study of Liver Diseases (AASLD) in San Diego on November 17, 2024. His presentation highlighted EvoLiver’s novel multiomics biomarker signature and its potential to reshape HCC detection through non-invasive, blood-based testing.
Mursla Bio’s dynamic biopsy technology bridges the gap between the precision of tissue biopsies and the convenience of liquid biopsies. By leveraging organ-specific EV isolation, an AI-enabled multiomics workflow, and a scalable assay platform, the company is setting a new standard in cancer diagnostics. With EvoLiver, Mursla Bio aims to redefine cancer outcomes for at-risk patients and offer clinicians a powerful new tool for combating liver cancer.
