Mursla Bio’s EvoLiver™ Receives Breakthrough Device Designation from FDA

Mursla Bio has announced that its lead product, EvoLiver™, has been granted Breakthrough Device Designation by the US Food and Drug Administration. The designation applies to the company’s Dynamic Biopsy-based blood test for the surveillance of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, in patients with liver cirrhosis who are at high risk.

The FDA’s Breakthrough Device Designation is intended for medical technologies that may provide a more effective diagnosis of serious or life-threatening diseases. It allows for an accelerated regulatory process, including priority review and closer collaboration with the agency, which can support faster market access and adoption.

HCC is currently the fastest-growing cause of cancer-related deaths worldwide. Despite recommendations for routine surveillance in high-risk groups, adherence to current monitoring protocols remains low. The current standard, ultrasound imaging, has limitations, especially in detecting small tumours and in patients with higher body weight, resulting in many cases being diagnosed at a later stage, when treatment options are limited.

Mursla Bio’s technology combines the diagnostic precision of tissue biopsies with the simplicity of blood-based testing. The company uses a novel platform that isolates organ-specific EVs from biofluids, coupled with an AI-powered multi-omics analysis to identify disease biomarkers. This approach offers a non-invasive, scalable, and more patient-friendly method for monitoring disease.