SHERIDAN, WYOMING – May 27, 2025 – Roche has introduced its Elecsys® PRO-C3 diagnostic test, marking a major step forward in the assessment of liver fibrosis severity, particularly in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). With the ability to deliver results in just 18 minutes, the new test is poised to streamline diagnostics and enable earlier, more accurate clinical decision-making.
Strategic Response to a Global Health Burden
MASLD, affecting approximately 30% of the global population, is increasingly prevalent due to rising rates of diabetes, obesity, and other cardiometabolic risk factors. While it contributes to around one in every 25 deaths globally, liver fibrosis associated with MASLD often progresses unnoticed until late stages, escalating risks of cirrhosis, liver failure, and cancer.
The Elecsys PRO-C3 test, developed with Nordic Bioscience, is designed to identify the presence and severity of fibrosis earlier in the disease lifecycle. This aligns with growing clinical demand for non-invasive, scalable diagnostics amid expanding treatment options.
“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.”
Fast, Reliable, and Cost-Effective Testing
The Elecsys PRO-C3 test integrates seamlessly with Roche’s cobas® analysers, requiring only a single assay to deliver reliable results in just 18 minutes. When used in combination with the ADAPT formula—incorporating PRO-C3 levels, platelet count, age, and diabetes status—the test enables a precise evaluation of liver fibrosis severity.
Key benefits include:
- Rapid turnaround: results in 18 minutes.
- Differentiation of fibrosis severity (≥F2, ≥F3, F4).
- Reduced need for invasive procedures like biopsies.
- Scalable use on existing cobas® platforms.
The ability to clearly distinguish between stages of fibrosis is crucial for identifying candidates for emerging pharmaceutical therapies, which have only recently become available for MASLD. Previously, treatment relied almost entirely on lifestyle interventions.
Digital Integration for Future-Ready Diagnostics
While the ADAPT score is currently calculated manually, Roche plans to launch software later in 2025 to automate this step—further streamlining workflows for healthcare providers. The integration of automated scoring tools into diagnostic systems reflects the industry trend toward digital health solutions that enhance efficiency and accuracy.
Supporting Innovation Through Scientific Leadership
Founded in 1896, Roche continues to lead global biotechnology and diagnostics innovation. The company’s commitment to sustainability and science-based healthcare is evident in its long-standing efforts to develop cutting-edge tools for early diagnosis and treatment.
With the introduction of the Elecsys PRO-C3 test, Roche not only reinforces its diagnostic leadership but also delivers on its mission to improve patient outcomes and ease the clinical burden associated with chronic liver disease.
Learn more at www.roche.com.