Patient-Friendly Blood Test to Transform Liver Cancer Surveillance

Hepatocellular carcinoma (HCC), the most common form of primary liver cancer, is the fastest-growing cause of cancer-related deaths. Although clinical guidelines recommend routine surveillance for high-risk individuals, adherence to these programs remains low. The current standard-of-care method, ultrasound, has limited sensitivity, particularly for detecting small tumors and in overweight patients. These limitations often lead to late diagnoses, poor patient outcomes, and rising healthcare costs. Now, a new blood-based diagnostic test has demonstrated early-stage sensitivity for liver cancer surveillance among cirrhotic, high-risk patients with diverse etiologies.

The test, EvoLiver, has been developed by Mursla Bio (Cambridge, UK) and leverages the company’s dynamic biopsy technology, which combines the accuracy of tissue biopsies with the convenience of liquid biopsies. Mursla developed the EvoLiver test by isolating organ-specific hepatocyte extracellular vesicles (h-EVs) from blood samples, enabling the validation of a novel HCC biomarker signature comprised of fewer than 10 h-EV microRNAs and proteins. The test’s effectiveness was demonstrated in the MEV01 multi-center clinical trial in collaboration with leading academic institutes that involved 464 patient samples, primarily collected prospectively, within a Western population. EvoLiver achieved 86% early-stage sensitivity at 88% specificity for liver cancer surveillance among cirrhotic, high-risk patients with diverse etiologies such as MASH / fatty liver disease, alcoholic liver disease, and hepatitis.

Image: EvoLiver is the first test to receive FDA Breakthrough Device Designation in five years in the liver cancer surveillance space (Photo courtesy of Mursla Bio)

EvoLiver’s low blood volume requirement and quick turnaround times support improved patient outcomes while streamlining disease management for clinicians and patients. The test’s ability to detect cancer at an early stage holds promise for improving surveillance outcomes in at-risk populations. The FDA has granted EvoLiver Breakthrough Device Designation, recognizing its potential to significantly improve early liver cancer detection in high-risk cirrhotic patients. The FDA designation not only validates the technology but also enables accelerated regulatory review, priority collaboration, and broader market adoption. Mursla is now advancing EvoLiver as a Laboratory Developed Test (LDT) in preparation for its product launch, while simultaneously pursuing future Premarket Approval (PMA) for full-scale commercialization.

“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 five years to receive FDA Breakthrough status. This is not another iteration on liquid biopsy – it is a leap,” said Pierre Arsène, Founder and CEO of Mursla Bio, and lead developer of the EvoLiver test. “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.”

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