Mursla Bio 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.
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.
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 surveillance.
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.
For further information on Mursla Bio, please visit https://mursla.com/.
