BOSTON — Mursla Bio, a biotechnology company specializing in extracellular vesicle (EV) science, announced that its blood-based liver cancer detection test, EvoLiver™, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The designation positions EvoLiver for expedited regulatory review and closer collaboration with the FDA, potentially accelerating its path to market.
EvoLiver is a non-invasive surveillance test designed for early detection of hepatocellular carcinoma (HCC), the most common type of primary liver cancer, in high-risk patients with cirrhosis. The test leverages Mursla Bio’s proprietary platform that isolates organ-specific extracellular vesicles circulating in the bloodstream, allowing for highly sensitive and specific cancer detection.
HCC is currently the fastest-growing cause of cancer-related deaths worldwide, with existing surveillance methods—primarily ultrasound—showing limited sensitivity, especially in overweight patients or when detecting small tumors. As a result, many cases are diagnosed at later stages, contributing to poorer outcomes and higher healthcare costs.
The FDA’s Breakthrough Device Designation is granted to technologies that offer significant advantages over existing diagnostic or treatment options for life-threatening conditions. The designation provides benefits such as priority review and enhanced FDA interaction, which are intended to speed up the development and commercialization process.
The designation follows results from Mursla Bio’s multi-center MEV01 clinical study, where EvoLiver demonstrated 86% sensitivity and 88% specificity for early-stage liver cancer detection, a significant improvement over current standards.
“This designation is a powerful validation of our scientific vision and clinical strategy,” said Pierre Arsène, Founder and CEO of Mursla Bio. “EvoLiver is the first liver cancer surveillance test in at least five years to receive FDA Breakthrough status. This is not just another liquid biopsy—it’s a leap forward. Our technology introduces a new diagnostic layer based on organ-specific EV intelligence, allowing us to detect disease in ways previously not possible.”
Mursla Bio’s “Dynamic Biopsy” technology combines the precision of tissue biopsies with the convenience of blood sample collection. This approach integrates EV isolation, AI-driven multi-omics analysis, and a scalable clinical assay platform to deliver comprehensive biological insights for disease detection.
As the company prepares for the commercial launch of EvoLiver, it is pursuing regulatory compliance as a Laboratory Developed Test (LDT) and planning future FDA approval through the Premarket Approval (PMA) pathway. This strategy aims to support broader clinical adoption and commercialization of the test.
EvoLiver’s development represents a promising advancement in liver cancer surveillance, offering a potentially more accurate, accessible, and patient-friendly option for early detection.
