Roche introduces innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity

Roche announced the launch of its Elecsys PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients showing signs of metabolic dysfunction–associated steatotic liver disease (MASLD). The test, developed in partnership with Nordic Bioscience, offers clinicians a simple and efficient method of identifying patients with liver fibrosis of varying severity, enabling timely intervention and appropriate management of the disease.

“The Elecsys PRO-C3 test addresses an urgent need in the diagnosis, staging and management of liver fibrosis,” said Matt Sause, CEO of Roche Diagnostics. “With MASLD affecting a growing number of people worldwide and new treatments emerging, it is critical to detect fibrosis accurately and early. 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 Elecsys PRO-C3 test requires only a single assay, which delivers results in only 18 minutes on Roche’s cobas analysers. This streamlines the process compared to currently available tests and reduces costs. Used in combination with the ADAPT formula, which includes PRO-C3 levels, platelet count, age and diabetes status, it provides a clear assessment of the severity of fibrosis, including distinguishing between different severities such as significant fibrosis (≥F2), advanced fibrosis (≥F3) and cirrhosis (F4). This is crucial for determining the appropriate treatment pathway for patients and identifying those who are eligible for new and emerging therapies. Initially, the ADAPT score will be calculated manually. Later this year, Roche is planning to launch software that will automate the calculation and further streamline liver fibrosis diagnosis.