SHERIDAN, WYOMING – May 8, 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today introduced the Elecsys® PRO-C3 test, a groundbreaking diagnostic solution designed to assess liver fibrosis severity in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). This innovative test, developed in partnership with Nordic Bioscience, provides healthcare providers with a fast and efficient way to evaluate liver fibrosis, a disease that contributes to one in every 25 deaths globally.
The Elecsys PRO-C3 test leverages Roche’s cobas® analyzers, delivering results in just 18 minutes, offering a swift and reliable diagnostic method. This new technology promises to significantly improve patient outcomes by enabling earlier identification of liver fibrosis, particularly in those affected by MASLD, and guiding timely treatment interventions.
Addressing a Growing Global Health Challenge
MASLD, which affects around 30% of the population, is one of the most prevalent causes of chronic liver disease in developed countries. It is primarily linked to metabolic conditions such as diabetes and obesity. Despite its widespread impact, liver fibrosis associated with MASLD often remains asymptomatic until advanced stages, making it challenging to detect early.
Matt Sause, CEO of Roche Diagnostics, highlighted the importance of early diagnosis in managing MASLD. “The Elecsys PRO-C3 test addresses an urgent need in the diagnosis, staging, and management of liver fibrosis,” Sause stated. “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.”
Simplifying the Diagnostic Process
Previously, liver fibrosis diagnosis required invasive biopsies or complex tests, which could be costly and time-consuming. The Elecsys PRO-C3 test offers a simpler and faster alternative. It provides a single assay that delivers results in only 18 minutes when used with Roche’s cobas® analysers, significantly streamlining the diagnostic process. This rapid turnaround time is expected to reduce diagnostic costs and improve patient throughput in clinical settings.
The test, used in combination with the ADAPT formula, assesses liver fibrosis severity by evaluating PRO-C3 levels, platelet count, age, and diabetes status. The result categorizes liver fibrosis into different stages: significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4). This clear classification allows clinicians to determine the appropriate treatment approach for patients, ensuring they receive the most effective care and, when appropriate, access to new and emerging therapies.
Transforming Disease Management with Emerging Therapies
Until recently, managing MASLD largely relied on lifestyle interventions, such as diet and exercise, with no pharmacological treatments available. However, with new drugs emerging to treat liver fibrosis, the ability to accurately assess the severity of the disease is more crucial than ever. The Elecsys PRO-C3 test empowers clinicians to identify patients eligible for these novel therapies, potentially improving liver function and slowing disease progression.
“New drug treatments for liver fibrosis are now emerging, giving clinicians, for the first time, a means of improving liver function and slowing disease progression,” added Sause. “The Elecsys PRO-C3 test is positioned to play a critical role in the management of this evolving landscape.”
Future Advancements and Automation
Currently, the ADAPT score is calculated manually; however, Roche plans to release software later this year that will automate the calculation process. This forthcoming software update will further streamline liver fibrosis diagnosis, enhancing efficiency and reducing the potential for human error.
About Roche
Roche is a global leader in biotechnology and diagnostics, founded in 1896 in Basel, Switzerland. The company is dedicated to improving and saving lives by developing innovative medicines and diagnostic solutions. Roche is at the forefront of personalized healthcare and strives to transform how healthcare is delivered to benefit individuals worldwide.
For more information, visit www.roche.com.