FDA Grants EvoLiver Biopsy Test Breakthrough Device Designation for HCC

HCC Surveillance 2.0: FDA Recognizes Mursla Bio’s Extracellular Vesicle Test

Pierre Arsène, drawing from his unconventional transition from investment banking to biophysics and bioengineering, built Mursla Bio—the Japanese pronunciation of Moore’s Law—with the same bold vision as George Moore: to double diagnostic efficiency while reducing barriers to access. Behind this philosophy, Arsène has led Mursla Bio to develop the EvoLiver Test, enabled by a novel platform based on organ-specific extracellular vesicles (EVs), fo…

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.

Mursla Bio’s platform for surveillance of liver cancer receives FDA approval - Pharmafile

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to EvoLiver, Mursla Bio’s surveillance platform for hepatocellular carcinoma (HCC), a common form of liver disease. With its support, Mursla hopes to improve the effectiveness of early liver cancer detection. The FDA’s BDD bolsters market access and commercial adoption by accelerating the […] The post Mursla Bio’s platform for surveillance of liver cancer…

FDA Grants EvoLiver Biopsy Test Breakthrough Device Designation for HCC

MEV01 trial results show that the test achieved an 86% early-stage sensitivity and 88% specificity in surveillance of HCC among patients with cirrhosis.

Mursla Bio's EvoLiver Test Gains FDA Breakthrough Designation

EvoLiver test shows promise in early liver cancer detection for high-risk patients, enhancing diagnostic potential.