Cambridge-based Mursla Bio secures FDA approval for EvoLiver
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Mursla Bio’s lead product, EvoLiver.
The go-ahead reflects the potential of the EvoLiver test to improve early liver cancer detection among high-risk patients.
EvoLiver’s blood-based test is enabled by a novel platform based on organ-specific Extracellular Vesicles (EVs) for the surveillance of hepatocellular carcinoma (HCC), the most common form of primary liver cancer in high-risk cirrhotic patients.
HCC is the fastest-growing cause of cancer-related deaths. Although clinical guidelines recommend routine surveillance for high-risk individuals, adherence to these programs remains low, and the standard-of-care method, based on ultrasound, has limited sensitivity, particularly for detecting small tumours and in overweight patients. Together, these challenges contribute to late diagnoses, poor patient outcomes, and escalating healthcare costs.
Mursla Bio, a leader in EV science, is on a mission to significantly improve cancer outcomes for at-risk patients through the power of its Dynamic Biopsy technology.
The proprietary biopsy platform non-invasively analyses dynamic biological processes within a specific organ or tissue to assess its health condition. It 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.
The FDA’s Breakthrough Device Designation is awarded to medical technologies that offer more effective diagnosis of life-threatening or irreversibly debilitating diseases and that represent a breakthrough over existing solutions. The designation follows the announcement of the company’s results from its MEV01 multi-centre clinical trial in which EvoLiver demonstrated 86 per cent early-stage sensitivity at 88 per cent specificity for liver cancer surveillance.
The designation enables an accelerated regulatory pathway, including priority review and closer collaboration with the FDA, which ultimately supports broader market reach and commercial adoption.
Pierre Arsène, founder and CEO of Mursla Bio, said: “This designation is a powerful validation of both our scientific vision and clinical strategy – EvoLiver is the first liver cancer surveillance test in at least five years to receive FDA Breakthrough status.
“This is not another iteration on liquid biopsy – it is a leap. We are creating a new diagnostic layer based on organ-specific EV intelligence, allowing us to identify disease in ways previously not possible.
“EvoLiver has the potential to transform liver cancer surveillance by enabling earlier detection through a more accurate, accessible, and patient-friendly blood test.”
