Elecsys PRO-C3 Test Aims to Improve Precision Evaluation of Liver Fibrosis Severity

On May 5, 2025, Roche and Nordic Bioscience launched the Elecsys PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients with signs of metabolic dysfunction–associated steatotic liver disease (MASLD). The test provides health care professionals with a simple and efficient method of identifying patients with liver fibrosis of varying severity, aiding in timely intervention and appropriate disease management.¹

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MASLD affects approximately 30% of the population and is one of the most common causes of chronic liver disease in the developed world. Primarily caused by diabetes, obesity, and other cardiometabolic risk factors (eg, hypertension, hyperlipidemia), a rapidly growing number of people are living with MASLD. This increased prevalence represents a significant burden for both patients and health systems worldwide, noted a news release.^1,2

Although MASLD is known for being responsible for approximately 1 in every 25 deaths globally, the liver fibrosis associated with MASLD is often asymptomatic until advanced stages; therefore, the disease can go undetected for years. Unmanaged, MASLD can lead to severe consequences such as cirrhosis, liver cancer, and liver failure. Of note, the National Institutes of Health estimates that approximately 20% of MASLD cases can progress to metabolic dysfunction-associated steatohepatitis (MASH).^1,2

The Elecsys PRO-C3 test requires only a single assay that delivers results in only 18 minutes on cobas analyzers. In addition to reducing costs, this test streamlines the process compared with tests that are currently available.^1,3

When used in combination with the ADAPT formula—which includes PRO-C3 levels, platelet count, age, and diabetes status—the Elecsys PRO-C3 test provides a clear assessment of the severity of fibrosis. Additionally, it is able to distinguish between different severities, such as significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4). This is crucial for determining the appropriate treatment pathway for patients and identifying those who are eligible for new and emerging therapies.^1,3

Currently, the ADAPT score must be calculated manually; however, the manufacturers aim to launch software that will automatically calculate the score, further streamlining the diagnosis of liver fibrosis.¹

PRO-C3 increased with fibrosis stage (Rho 0.50; P < 0.0001) and was independently associated with advanced fibrosis (OR: 1.05 [95% CI 1.02-1.08]; P = 0.003), according to findings of a 2019 study published in Hepatology. For ≥F3, ADAPT demonstrated areas under the receiver operating characteristics curve of about 0.86 (95% CI 0.79-0.91) in a derivation cohort and 0.87 in a validation cohort (95% CI 0.83-0.91). These findings showed that PRO-C3 is an independent predictor of fibrosis stage in MASLD and identifies patients with MASLD and ≥F3. It was superior to aspartate aminotransferase to platelet ratio index, FIB-4, and nonalcoholic fatty liver disease fibrosis score.^1,4

"The Elecsys PRO-C3 test addresses an urgent need in the diagnosis, staging and management of liver fibrosis," Matt Sause, CEO of Roche Diagnostics, said in a news release. "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 health care services, providing a clear and rapid assessment while reducing the requirement for invasive biopsies."¹

REFERENCES

1. Roche. Roche introduces innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity. News release. May 5, 2025. Accessed May 29, 2025. https://www.roche.com/media/releases/med-cor-2025-05-06

2. Friedman SL. Fat, fibrosis, and the future: navigating the maze of MASLD/MASH. J Clin Invest. 2025;135(7):e186418. Published 2025 Apr 1. doi:10.1172/JCI186418.

3. Nordic Bioscience. Biomarker Portfolio. Accessed May 29, 2025.https://www.nordicbioscience.com/technology/biomarkers/pro-c3-nordicpro-c3

4. Daniels SJ, Leeming DJ, Eslam M, et al. ADAPT: An Algorithm Incorporating PRO-C3 Accurately Identifies Patients With NAFLD and Advanced Fibrosis. Hepatology. 2019;69(3):1075-1086. doi:10.1002/hep.30163