Mursla Bio’s platform for surveillance of liver cancer receives FDA approval
Ella Day | April 24, 2025 | News story | Industry Associations, Research and Development | BDD, FDA, Mursla Bio, Oncology, hepatocellular carcinoma (HCC), liver disease
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to EvoLiver, Mursla Bio’s surveillance platform for hepatocellular carcinoma (HCC), a common form of liver disease. With its support, Mursla hopes to improve the effectiveness of early liver cancer detection.
The FDA’s BDD bolsters market access and commercial adoption by accelerating the regulatory pathway, including priority review and closer cooperation with the FDA. It has recognised the potential of EvoLiver, a dynamic biopsy-based blood test, based on liver-specific extracellular vesicle (EV), as a breakthrough product for effective diagnosis of HCC.”
This investment in the product follows successful outcomes from the MEV01 clinical trial on the product, which demonstrated 86% early-stage sensitivity at 88% specificity for liver cancer surveillance.
Despite being the fastest-growing cause of cancer related deaths, early diagnosis rates of HCC are poor, exacerbating treatment costs. This is as a result of poor adherence to routine surveillance of high-risk individuals and limitations of conventionally-used ultrasounds. With the FDA’s support, Mursla hopes to meet this medical need.
Pieree Arsène, CEO of Mursla, commented: “EvoLiver is the first liver cancer surveillance test in at least five years to receive FDA Breakthrough status.” He adds: “It has the potential to transform liver cancer surveillance by enabling earlier detection through a more accurate, accessible and patient-friendly blood test.”
Ella Day
24/4/25
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