Roche has introduced the Elecsys PRO-C3 test, designed to assess the severity of liver fibrosis in individuals diagnosed with metabolic dysfunction–associated steatotic liver disease (MASLD).
The diagnostic solution was developed through a licensing partnership with Nordic Bioscience and will be available on Roche’s cobas analyser systems.
The PRO-C3 test offers clinicians a method for evaluating liver fibrosis severity using a single serum assay, delivering results within 18 minutes.
The test is intended for use in combination with the ADAPT score, a diagnostic formula incorporating the patient’s age, platelet count, PRO-C3 biomarker levels, and diabetes status. This approach enables differentiation between stages of fibrosis, including significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4).
Nordic Bioscience CEO Morten Karsdal said: “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.”
MASLD currently affects an estimated 30% of the global population and is closely linked to cardiometabolic risk factors such as obesity and type 2 diabetes.
Despite its widespread prevalence, liver fibrosis resulting from MASLD typically remains undetected until its later stages. The asymptomatic nature of the disease increases the risk of progression to cirrhosis, hepatocellular carcinoma, or liver failure.
Until recently, therapeutic options for MASLD were limited to non-pharmacological interventions such as dietary changes and physical activity. However, with new therapies under development targeting liver fibrosis, there is growing demand for diagnostic tools that can accurately stratify patients and monitor disease progression.
Roche Diagnostics CEO Matt Sause said: “The Elecsys PRO-C3 test addresses an urgent need in the diagnosis, staging and management of liver fibrosis.
“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.”
Roche’s Elecsys PRO-C3 test is being positioned as a cost-efficient alternative to existing fibrosis diagnostics by reducing procedural complexity and delivering rapid turnaround times. Initially, the ADAPT score will be calculated manually by clinicians. However, Roche has confirmed that it plans to launch software later this year that will automate the process, further optimising clinical workflows.
The test is underpinned by Nordic Bioscience’s PRO-C3 biomarker, which has been validated in its CAP-CLIA certified laboratory in Denmark. The PRO-C3 assay was previously offered as a laboratory service by Nordic Bioscience but will now be available on Roche’s automated testing platform under the Elecsys brand.
According to Nordic Bioscience, the PRO-C3 assay reflects structural changes in type III collagen, offering insights into active fibrogenesis. The inclusion of PRO-C3 in the ADAPT score allows a more precise assessment of disease staging, essential for determining patient eligibility for emerging treatments.
