Mursla Bio’s EvoLiver Exceeds Current Liver Cancer Surveillance Standards at AASLD 2024

Mursla Bio, an established leader in Extracellular Vesicle (EV) science, has unveiled promising results from its multi-centre clinical study, MEV01. The study, conducted in collaboration with prestigious academic institutions such as University College London, Imperial College London, University Hospital of Santa Maria, and the Medical University of Graz, focuses on the company's dynamic biopsy-based blood test, EvoLiver™. This test is designed to monitor primary liver cancer, Hepatocellular Carcinoma (HCC), in high-risk patients with cirrhosis.

The EvoLiver test showed remarkable efficacy in early-stage detection of HCC, boasting 86% sensitivity and 88% specificity. These numbers significantly outperform current surveillance methods like ultrasound and alpha-fetoprotein testing. The study results, derived from 464 patient samples collected mainly prospectively from a western population, encompass various etiologies such as MASH/fatty liver disease, alcoholic liver disease, and hepatitis.

The innovation behind EvoLiver lies in isolating liver-specific hepatocyte extracellular vesicles (h-EVs) from blood samples. This process allows for the validation of a novel HCC biomarker signature, consisting of fewer than 10 h-EV microRNAs and proteins. The growing population at risk for HCC places a substantial economic strain on healthcare systems, as existing surveillance methods often struggle with early detection, particularly in overweight patients. The development of an affordable, blood-based surveillance tool with enhanced sensitivity could revolutionize patient outcomes due to better treatment options.

EvoLiver employs a cutting-edge platform that isolates h-EVs to identify and validate new multiomics biomarkers. This aids in distinguishing HCC with cirrhosis from non-cancerous cirrhosis. The test’s need for only a small blood volume and its rapid results contribute to improved patient management and outcomes. Looking ahead, Mursla Bio aims to publish the final MEV01 results in 2025, introduce the test in the US as a Laboratory Developed Test (LDT), and initiate a larger study to achieve FDA approval and widespread reimbursement coverage.

Pierre Arsène, Mursla Bio’s Founder and CEO, highlighted the significance of their flagship test, emphasizing its ability to non-invasively capture dynamic cellular processes from specific tissues through organ-specific EVs. This method detects early-stage HCC with much greater sensitivity than standard techniques. Early detection is crucial for improving survival rates as it allows for timely and effective treatments such as ablation, resection, or transplant. Moreover, the blood-based approach of EvoLiver is more convenient, likely increasing patient adherence to surveillance testing. EvoLiver marks a significant advancement in the detection and monitoring of liver cancer.

Mursla Bio’s dynamic biopsy technology merges the precision and disease sub-typing capabilities of tissue biopsies with the simplicity of liquid biopsy sample collection. This non-invasive intervention offers comprehensive biological insights, facilitated by advanced EV science and an innovative extracellular omics approach. Mursla Bio’s suite of technologies includes organ-specific EV isolation from biofluids for precise targeting, an AI-driven multi-omics workflow for disease biomarker identification, and a scalable assay platform optimized for clinical use.

Dr. Tomás Dias, Mursla Bio’s Chief Scientific Officer, presented data from the MEV01 study at AASLD’s The Liver Meeting in San Diego, on November 17, 2024. His presentation, titled "Novel multiomics biomarker signature derived from blood circulating hepatocyte-extracellular vesicles for the early detection of HCC," underscored the groundbreaking nature of Mursla Bio's research and its potential to transform liver cancer surveillance and outcomes.