Roche is rolling out a new diagnostic test to help assess hidden liver fibrosis in patients showing signs of metabolic dysfunction-associated steatotic liver disease, or MASLD.
The company said its 18-minute Elecsys PRO-C3 blood test, run on its cobas e instruments, is used alongside a formula that accounts for other clinical information—such as the patient’s age, diabetes status and platelet count. Its findings can help guide treatment and potentially provide access to upcoming therapies.
“The Elecsys PRO-C3 test addresses an urgent need in the diagnosis, staging and management of liver fibrosis,” Roche Diagnostics CEO Matt Sause said in a statement.
“With MASLD affecting a growing number of people worldwide and new treatments emerging, it is critical to detect fibrosis accurately and early,” Sause added. “Our innovative solution simplifies the diagnostic process and eases the burden on healthcare services, providing a clear and rapid assessment while reducing the requirement for invasive biopsies.”
The PRO-C3 biomarker—short for the neo-epitope-specific, N-terminal pro-peptide of type-III collagen—is released into the bloodstream as fibrotic scarring begins to form, and has been used to predict progression in patients with other liver-affecting diseases like hepatitis C.
MASLD—formerly known as NAFLD, or non-alcoholic fatty liver disease—affects about 30% of the world’s population, according to Roche, and can evolve into MASH, or metabolic dysfunction-associated steatohepatitis, where swelling and scarring starts to threaten organ function.
Roche said tracking PRO-C3 can help provide an early warning to the fibrosis that accounts for about one in every 25 deaths globally. The immunoassay test, developed in collaboration with Nordic Bioscience, can categorize patients by severity, including moderate fibrosis, severe fibrosis and late-stage cirrhosis of the liver.
The company said the parallel clinical formula, known as a patient’s ADAPT score, will be calculated by providers manually at first, but the company plans to launch software later this year that will automate that analysis.
Last March, the FDA approved its first drug specifically for treating MASH, with Madrigal Pharmaceuticals’ Rezdiffra (resmetirom). The tablet was greenlit for patients with moderate or severe fibrosis, and industry watchers have said it has opened the door to a new market with a significant unmet need.