Cambridge-based startup Mursla Bio has received FDA Breakthrough Device Designation for its innovative liver cancer surveillance test, EvoLiver, marking a significant advancement in early cancer detection technology.
The designation, which supports an accelerated regulatory pathway and closer collaboration with the FDA, recognizes EvoLiver as the first liver cancer surveillance test in at least five years to receive this status.
Revolutionary Approach to Liquid Biopsy
EvoLiver represents a fundamental shift in liquid biopsy technology by utilizing extracellular vesicles (EVs) to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Unlike traditional liquid biopsy approaches, Mursla's technology targets organ-specific EVs, creating what the company describes as "a new diagnostic layer."
"This is not another iteration on liquid biopsy - it is a leap," said Pierre Arsène, Founder and CEO of Mursla Bio. "We are creating a new diagnostic layer based on organ-specific EV intelligence, allowing us to identify disease in ways previously not possible."
The technology combines the comprehensive biological insights typically associated with tissue biopsies with the convenience and non-invasive nature of blood-based testing.
Impressive Clinical Performance
EvoLiver's potential was demonstrated in the company's MEV01 multi-center clinical trial, where it achieved 86% early-stage sensitivity at 88% specificity for liver cancer surveillance. These results suggest significant improvement over current surveillance methods.
The test addresses critical gaps in the current standard of care for HCC surveillance, which relies primarily on ultrasound imaging. Current methods face limitations in detecting small tumors and are particularly challenging to use effectively in overweight patients.
Addressing a Growing Health Crisis
HCC represents the fastest-growing cause of cancer-related deaths globally. Despite clinical guidelines recommending routine surveillance for high-risk individuals, adherence to these programs remains low, contributing to late diagnoses and poor patient outcomes.
"EvoLiver has the potential to transform liver cancer surveillance by enabling earlier detection through a more accurate, accessible, and patient-friendly blood test," Arsène explained.
Technical Innovation
Mursla Bio's approach leverages several proprietary technologies:
- Organ-specific EV isolation from biofluids for precise targeting
- AI-enabled multi-omics workflow for disease biomarker identification
- A scalable assay platform using optimal biomarkers for clinical applications
This comprehensive technological framework allows for more precise disease detection and potentially earlier intervention for patients at risk.
Regulatory and Commercial Pathway
Following this breakthrough designation, Mursla Bio is advancing regulatory compliance for EvoLiver as a Laboratory Developed Test in preparation for its upcoming product launch. The company is simultaneously laying groundwork for future FDA approval through the Premarket Approval pathway.
The Breakthrough Device Designation is expected to support broader market reach and commercial adoption by providing priority review and facilitating closer collaboration with regulatory authorities.
For patients at high risk of developing HCC, particularly those with cirrhosis, this technology could represent a significant improvement in surveillance options, potentially leading to earlier detection and improved survival rates.
