Mursla Bio has revealed outcomes from the MEV01 clinical study of its ‘EvoLiver’ blood test for the surveillance of hepatocellular carcinoma (HCC), primary liver cancer in high-risk cirrhotic individuals.
The test has shown an 86% early-stage sensitivity and 88% specificity, outperforming traditional methods such as ultrasound and alpha-fetoprotein testing.
The study, conducted in collaboration with University College London, Imperial College London, University Hospital of Santa Maria, and the Medical University of Graz, analysed 464 patient samples.
These samples were mainly collected from western people with liver disease aetiologies such as hepatitis, metabolic dysfunction-associated steatohepatitis (MASH)/fatty liver disease and alcoholic liver disease.
EvoLiver was developed by isolating organ-specific hepatocyte extracellular vesicles (h-EVs) from blood samples.
This led to the validation of a HCC biomarker signature, comprising less than ten h-EV microRNAs and proteins. The test's requirement for a low blood volume and quick turnaround times could also streamline disease management for both clinicians and patients.
EvoLiver's innovative approach claims to potentially transform patient outcomes, given the availability of treatment options.
Mursla Bio founder and CEO Pierre Arsѐne said: “Our flagship test has shown that our pioneering method of non-invasively capturing dynamic cellular processes from specific tissues via organ-specific EVs [extracellular vesicles] 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.”
The company plans to publish the outcomes of the MEV01 multi-centre study next year, introduce EvoLiver in the US as a laboratory-developed test (LDT), and conduct a larger study to obtain approval from the US Food and Drug Administration and extensive reimbursement coverage.
