Innovative Test Accurately Evaluates Liver Fibrosis Severity in Just 18 Minutes

Metabolic dysfunction–associated steatotic liver disease (MASLD) affects approximately 30% of the population and is one of the leading causes of chronic liver disease in developed countries. Primarily caused by conditions like diabetes, obesity, and other cardiometabolic risk factors, MASLD is becoming increasingly prevalent, placing a significant burden on both patients and healthcare systems globally. Despite being responsible for about one in every 25 deaths worldwide, the liver fibrosis associated with MASLD often remains asymptomatic until it reaches advanced stages, and can go undetected for years. If left unmanaged, it can result in severe complications, including cirrhosis, liver cancer, and liver failure. Now, a new diagnostic test offers a way to identify patients with significant liver fibrosis at an earlier stage, which could lead to improved outcomes through timely treatment and access to emerging therapies.

Roche (Basel, Switzerland) has launched Elecsys PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients showing signs of MASLD. The test, developed in partnership with Nordic Bioscience (Herlev, Denmark), provides clinicians with a simple, efficient method for identifying patients with varying levels of liver fibrosis, allowing for timely intervention and proper management of the disease. The Elecsys PRO-C3 test requires just one assay and delivers results in only 18 minutes on Roche's cobas analyzers, streamlining the diagnostic process and reducing costs compared to currently available tests. When combined with the ADAPT formula—which includes PRO-C3 levels, platelet count, age, and diabetes status—the test offers a comprehensive assessment of fibrosis severity, helping distinguish between stages like significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4).

This is particularly important for determining the appropriate treatment for patients and identifying those who could benefit from new and emerging therapies. Until recently, no medications were available for treating MASLD, and management focused mainly on lifestyle changes such as diet and exercise. However, new drug treatments for liver fibrosis are now emerging, offering clinicians the first opportunity to improve liver function and slow the progression of the disease. Initially, the ADAPT score will be calculated manually, but later this year, Roche plans to launch software that will automate this calculation, further simplifying the diagnosis of liver fibrosis.

"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."