Roche launches Elecsys PRO-C3 test for liver fibrosis
Basel: Roche has announced the launch of its ElecsysPRO-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).
According to Roche, 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 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.
MASLD affects around 30% of the population, and is one of the most common causes of chronic liver disease in the developed world. Caused mainly by diabetes, obesity and other cardiometabolic risk factors, a rapidly growing number of people are living with MASLD, representing a significant burden for patients and health systems worldwide. However, despite being responsible for approximately one in every 25 deaths globally, the liver fibrosis associated with MASLD is often asymptomatic until the advanced stages and can go undetected for years. Unmanaged, it can lead to severe consequences such as cirrhosis, liver cancer, and liver failure.
"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."
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.
