One-sentence summary:
Mursla Bio has received FDA Breakthrough Device Designation for EvoLiver, a novel blood test using Dynamic Biopsy technology for early and accurate surveillance of liver cancer in high-risk patients.
Three brief takeaways:
- EvoLiver’s high early-stage sensitivity (86%) and specificity (88%) offer a significant advancement over ultrasound-based liver cancer screening.
- The FDA Breakthrough status accelerates regulatory approval and supports broader clinical and commercial adoption.
- Mursla Bio’s Dynamic Biopsy platform leverages organ-specific extracellular vesicles and AI to provide a non-invasive, scalable, and precise diagnostic tool.
Mursla Bio, an extracellular vesicle (EV) science company on a mission to significantly improve cancer outcomes for at-risk patients through the power of Dynamic Biopsy technology, has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its lead product, EvoLiver. The designation recognizes the potential of the Company’s Dynamic Biopsy-based blood test, EvoLiver, which is enabled by a novel platform based on organ-specific EVs for the surveillance of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, in high-risk cirrhotic patients.
Breakthrough Device Designation Accelerates Regulatory Pathway
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 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 the Company’s results from its MEV01 multi-center clinical in which EvoLiver demonstrated 86% early-stage sensitivity at 88% specificity for liver cancer surveillance1.
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.”
EvoLiver Being Prepared for Future Commercial Scale-up
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.
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.
Featured Image: Pierre Arsène, founder and CEO of Mursla Bio. Image: Mursla Bio
