FDA Grants Breakthrough Designation for EvoLiver in HCC
EvoLiver, a blood test that detects early-stage liver cancer with high accuracy, has gained breakthrough device designation from the FDA.
US FDA
- The FDA has granted breakthrough device designation to the EvoLiver test, developed by Mursla Bio, for surveillance of hepatocellular carcinoma (HCC) in patients with high-risk cirrhosis.
- This marks the first such liver cancer test to receive this status in over 5 years.
- Data from the MEV01 trial presented at the 2024 American Association for the Study of Liver Diseases (AASLD) Liver Meeting support this designation.
The FDA has granted breakthrough device designation to the EvoLiver test for the surveillance of hepatocellular carcinoma (HCC) in patients with high-risk cirrhosis.
This designation is supported by findings from the MEV01 trial which were presented at the 2024 AASLD Liver Meeting.2 Here, EvoLiver's extracellular vesicle (EV) multiomics biomarker signature achieved 86% sensitivity for early-stage HCC and 88% specificity, significantly outperforming standard techniques like ultrasound and alpha-fetoprotein testing.
The study prospectively collected data from 464 patient samples which were primarily collected prospectively and within a western population. Etiologies represented in the study included metabolic dysfunction-associated steatohepatitis (MASH)/fatty liver disease, alcoholic liver disease, and hepatitis.
3D illustration of human liver: © PIC4U - stock.adobe.com
“Our flagship test has shown that our pioneering method of noninvasively capturing dynamic cellular processes from specific tissues via organ-specific EVs can detect early-stage HCC with far greater sensitivity than standard techniques,” Pierre Arsène, founder and chief executive officer of Mursla Bio, said in a press release.1 “Earlier detection is critical to improving survival rates, as it enables access to effective treatments such as ablation, resection, or transplant. Our blood modality is also a more convenient method that will increase patient adherence to surveillance testing. EvoLiver represents an important step forward in the way liver cancer is detected and monitored.”
About the EvoLiver Test
EvoLiver™ is an innovative blood-based diagnostic test developed by Mursla Bio for the early detection and surveillance of patients with HCC who have high-risk cirrhosis.1,2 Utilizing a pioneering platform that isolates organ-specific hepatocyte extracellular vesicles, EvoLiver identifies and validates a novel multiomics biomarker signature—comprising fewer than 10 microRNAs and proteins—to accurately distinguish HCC from noncancerous cirrhosis.
With a low blood volume requirement, rapid turnaround, and a noninvasive approach, EvoLiver enhances patient adherence, streamlines clinical decision-making, and supports improved outcomes. Final results from MEV01 are expected to be announced in 2025, and a larger study plans to initiate to pursue full FDA approval and broad reimbursement.
Behind the MEV01 Trial
MEV01 is an ongoing trial that started in 2022, prospectively collecting a maximum of 800 patient samples from over 500 high-risk patients diagnosed with cirrhosis and 300 patients who are considered to be at a high risk for HCC who are diagnosed with cirrhosis.3 More than 150 of these patients will have HCC.
The study is ongoing at more than 5 real-world practices, including hospitals at Imperial College London and UCL Cancer Institute. Final results and peer-reviewed publication are expected to be released in 2025.
“This designation is a powerful validation of both our scientific vision and clinical strategy. EvoLiver is the first liver cancer surveillance test in at least 5 years to receive FDA breakthrough status,” Arsène said in the news release on the FDA decision.1 “This is not another iteration on liquid biopsy; it is a leap. We are creating a new diagnostic layer based on organ-specific EV intelligence, enabling us to identify disease in ways previously not possible. EvoLiver has the potential to transform liver cancer surveillance by enabling earlier detection through a more accurate, accessible, and patient-friendly blood test.”
