The biopsy-based blood test can detect liver cancer.
Biotechnology company Mursla Bio has received FDA Breakthrough Device Designation for its EvoLiver test.
The Breakthrough status allows for expedited review and closer collaboration with the FDA, enabling broader market research and commercial adoption.
EvoLiver is a biopsy-based blood test enabled by a novel platform based on organ-specific extracellular vesicle (EV) for the surveillance of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, in high-risk cirrhotic patients.
The Breakthrough Device Designation is given to medical technologies that provide more effective diagnosis of life-threatening or irreversibly debilitating diseases.
HCC is the fastest-growing cause of cancer-related deaths. It is often diagnosed late and has a poor prognosis, partly because the standard-of-care method, based on ultrasound, has limited sensitivity.
EvoLiver demonstrated 86% early-stage sensitivity at 88% specificity for liver cancer surveillance.
Last year, Mursla joined Everest, a European consortium aiming to advance extracellular vesicle (EV) research, innovation and clinical translation for the benefit of patients.
