Roche has launched a groundbreaking diagnostic solution aimed at transforming liver fibrosis assessment in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The new Elecsys PRO-C3 test, developed in partnership with Nordic Bioscience, provides clinicians with a simple and efficient method to identify and evaluate liver fibrosis severity, enabling more targeted treatment approaches.
The test addresses a critical healthcare need as MASLD affects approximately 30% of the population and represents one of the most common causes of chronic liver disease in developed countries. Liver fibrosis associated with MASLD is responsible for approximately one in every 25 deaths globally but often remains undetected until advanced stages due to its asymptomatic nature.
"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."
Test Methodology and Clinical Utility
The Elecsys PRO-C3 test requires only a single assay that delivers results in 18 minutes on Roche's cobas analyzers, significantly streamlining the diagnostic process compared to currently available methods. When used with the ADAPT formula, which incorporates PRO-C3 levels, platelet count, age, and diabetes status, the test provides clear assessment of fibrosis severity.
Importantly, the test can distinguish between different fibrosis stages, including significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4). This differentiation is crucial for determining appropriate treatment pathways, particularly as new therapeutic options for liver fibrosis emerge.
Currently, the ADAPT score must be calculated manually, but Roche plans to launch software later this year that will automate this calculation, further streamlining the diagnostic process.
Disease Burden and Treatment Landscape
MASLD is primarily caused by diabetes, obesity, and other cardiometabolic risk factors. The rapidly growing prevalence represents a significant burden for both patients and healthcare systems worldwide. If left unmanaged, liver fibrosis can progress to severe complications including cirrhosis, liver cancer, and liver failure.
Until recently, management options for MASLD were limited to lifestyle interventions such as diet and exercise, with no specific pharmaceutical treatments available. However, new drug treatments for liver fibrosis are now emerging, giving clinicians the ability to improve liver function and slow disease progression for the first time.
Nordic Bioscience Collaboration
The PRO-C3 biomarker was originally developed by Nordic Bioscience, whose scientists have published more than 250 scientific papers on PRO-C3 over the past decade, establishing the company as a leader in fibrosis-related disease research.
"The Elecsys PRO-C3 test is the first test launched from the collaboration between Nordic Bioscience and Roche Diagnostics. We are proud that our technology becomes globally available to make a difference for patients," said Morten Karsdal, CEO of Nordic Bioscience.
The biomarker was previously available as a service performed in Nordic Bioscience's laboratory in Denmark using the nordicPRO-C3™ test. The Elecsys PRO-C3 test was developed under a license agreement between Nordic Bioscience and Roche Diagnostics.
Future Implications
The introduction of the Elecsys PRO-C3 test comes at a critical time as the prevalence of MASLD continues to rise globally. With 40% of deaths in Western countries associated with alterations of organs such as the liver, improved diagnostic tools are essential for early intervention and treatment.
As the first of Nordic Bioscience's biomarkers from their fibrosis panel to receive CE approval, the Elecsys PRO-C3 test represents an important advancement in modern clinical chemistry. The global availability of this technology through Roche's extensive diagnostic network has the potential to significantly impact patient care and outcomes in liver disease management worldwide.
