Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to significantly improve cancer outcomes for at-risk patients through the power of dynamic biopsy technology, today announced results of its multi-center clinical study, MEV01, in collaboration with leading academic institutes including University College London, Imperial College London, University Hospital of Santa Maria and the Medical University of Graz.
Pierre Arsène, Founder and CEO, Mursla Bio. Image Credit: Mursla Bio
The ongoing study is investigating the Company’s dynamic biopsy-based blood test, EvoLiver™, for the surveillance of primary liver cancer, Hepatocellular Carcinoma (HCC), among high-risk, cirrhotic patients. Mursla Bio established the first EV multiomics biomarker signature for HCC with 86% early-stage sensitivity and 88% specificity, significantly surpassing existing surveillance techniques including ultrasound and alpha-fetoprotein testing.
The results are part of MEV01 and based on 464 patient samples, primarily collected prospectively, within a western population, representing etiologies such as MASH / fatty liver disease, alcoholic liver disease and hepatitis. Mursla Bio developed the EvoLiver test by isolating organ-specific hepatocyte extracellular vesicles (h-EVs) from blood samples, enabling the validation of a novel HCC biomarker signature comprised of fewer than 10 h-EV microRNAs and proteins.
The expanding population at risk of developing HCC is placing an increasing economic burden on healthcare systems due to current surveillance methods, including ultrasound, which often have difficulties detecting small tumors especially in overweight patients. An affordable, blood-based surveillance tool with significantly improved sensitivity would transform patient outcomes given the existing treatment options. Identifying HCC-specific blood biomarkers remains challenging due to the complexity of liver disease and the difficulty in detecting varied etiologies.
EvoLiver leverages a pioneering platform that isolates h-EVs, identifies and validates novel multiomics biomarkers to distinguish HCC with cirrhosis from non-cancerous cirrhosis. EvoLiver’s low blood volume requirement and quick turnaround times support improved patient outcomes while streamlining disease management for clinicians and patients. The company’s next steps with EvoLiver are to publish final MEV01 results in 2025, offer the test in the US as a Laboratory Developed Test (LDT), and set up a larger study to secure FDA approval and broad reimbursement coverage.
Our flagship test has shown that our pioneering method of non-invasively capturing dynamic cellular processes from specific tissues via organ-specific EVs can detect early-stage HCC with far greater sensitivity than standard techniques. Earlier detection is critical to improving survival rates, as it enables access to effective treatments such as ablation, resection, or transplant. Our blood modality is also a more convenient method that will increase patient adherence to surveillance testing. EvoLiver represents an important step forward in the way liver cancer is detected and monitored.”
Pierre Arsène, Founder and CEO, Mursla Bio
Mursla Bio’s dynamic biopsy technology combines the accuracy and disease sub-typing capabilities of tissue biopsies with the ease of liquid biopsy sample collection, providing a non-invasive intervention with comprehensive biological insights. This is made possible by advanced EV science and an innovative extracellular omics approach, supported by Mursla Bio’s technologies. These technologies include organ-specific EV isolation from biofluids for precise targeting, an AI-enabled multi-omics workflow for disease biomarker identification, and a scalable assay platform using optimal biomarkers for clinical use.
Dr Tomás Dias, Mursla Bio’s CSO, presented data from the study at one of the largest medical conferences, AASLD’s The Liver Meeting, in San Diego, on 17 November 2024 in a presentation titled: “Novel multiomics biomarker signature derived from blood circulating hepatocyte-extracellular vesicles for the early detection of HCC”.
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