Liver cancer diagnostic gets FDA breakthrough status, with Pierre Arséne, Mursla Bio

Despite a certain amount of upheaval at the FDA, the agency has continued to keep up with its scheduled approvals and clearances. At BIO 2025, editor-in-chief Jonah Comstock sat down with Mursla Bio CEO and founder Pierre Arséne, whose company just received a breakthrough designation from the FDA for a blood test to catch liver cancer early.
In this interview, Arséne explains what this designation means for the company, the outsized effect that early detection can have on both costs and patient survival, and how the company is moving to deploy the product in the United States and Europe.
They discuss what it’s like to work with the FDA right now, as well as the advantages of blood-based biomarkers for early cancer detection and Mursla’s move into the US market. Arséne also teases some other products they have in the works and an NIH trial that they have recently joined.
Take a look at the video below and be sure to visit our BIO Spotlight page for more coverage from the show.