FDA Breakthrough Device Designation Granted to Mursla Bio’s EvoLiver Test

Mursla Bio’s lead product, EvoLiver, has been awarded U.S. Food and Drug Administration (FDA) Breakthrough Device Designation. A Dynamic Biopsy-based blood test, EvoLiver is enabled by a novel platform based on organ-specific extracellular vesicles (EVs) for surveilling hepatocellular carcinoma (HCC), the most common form of primary liver cancer, in high-risk cirrhotic patients.

The FDA’s Breakthrough Device Designation is awarded to medical technologies that offer more effective diagnosis of life-threatening or irreversibly debilitating diseases and represent a breakthrough compared to existing solutions. 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. 

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 tumors and in overweight patients. Together, these challenges contribute to late diagnoses, poor patient outcomes, and escalating healthcare costs. The FDA’s Breakthrough Device Designation follows the announcement of results from the company’s MEV01 multi-center clinical, in which EvoLiver demonstrated 86% early-stage sensitivity at 88% specificity for liver cancer surveillance.¹

“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,” Mursla Bio Founder/CEO Pierre Arsène said. “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.”

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 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.

Mursla Bio is advancing regulatory compliance for EvoLiver as a Laboratory Developed Test (LDT) in preparation for its upcoming product launch, while also laying the groundwork for future FDA approval through the Premarket Approval (PMA) pathway to enable broader clinical and commercial scale-up.

Mursla Bio is a biotech company striving to improve cancer outcomes for at-risk patients through Dynamic Biopsy. The company’s proprietary biopsy platform non-invasively analyzes dynamic biological processes within a specific organ or tissue to assess its health condition. This approach combines the accuracy and disease sub-typing capabilities of tissue biopsies with the ease of liquid biopsy sample collection. The company’s initial focus is on transforming the surveillance of liver cancer in high-risk populations, the fastest growing cause of cancer related deaths. Mursla Bio is based in Cambridge, United Kingdom, and Boston.

Reference
¹ Press release: Mursla Bio’s EvoLiver surpasses current standards in liver cancer surveillance