NordicPRO-C3™ predictor of liver disease

Liver fibrosis is a progressive condition characterized by the excessive accumulation of scar tissue in the liver, often resulting from chronic liver diseases. Fibroblast activity plays a critical role in the progression of fibrosis, leading to organ function loss and liver-related complications. Liver fibrosis accounts for approximately 2 million deaths worldwide, while alcohol-related liver disease (ArLD) causes over 330,000 cirrhosis deaths globally every year.

In two recent studies, we investigated the fibrogenesis biomarker nordicPRO-C3™ in the context of advanced liver disease and full-spectrum fibrosis in alcohol-related liver disease. Our goal was to assess the nordicPRO-C3™ biomarker’s potential prognostic value and clinical utility as a predictor of outcome, and our results are very promising.

The nordicPRO-C3™ biomarker is capable of identifying advanced liver fibrosis and alcohol-related liver disease, providing a new clinical utility tool

In the first paper, published in JHEP Reports, we conducted investigations using two distinct cohorts of patients with compensated cirrhosis of mixed etiologies. In both cohorts, a 2-fold increase in nordicPRO-C3™ at baseline was associated with a significant hazard increase for liver-related events. Notably, nordicPRO-C3™ exhibited prognostic significance.

The identification of nordicPRO-C3™ as an independent prognostic factor for liver-related clinical outcomes has important implications for both drug development and clinical practice. By understanding the dynamic range of nordicPRO-C3™, researchers can improve its utility as a predictive marker in drug trials, enabling the development of targeted therapies to mitigate fibrosis progression and improve patient outcomes.

In a clinical setting, the integration of nordicPRO-C3™ measurement alongside established markers such as fibrosis-4 index (FIB-4) or transient elastography (TE) may enhance risk stratification and inform treatment decisions. Early identification of patients at higher risk for liver-related events can facilitate timely interventions, such as disease monitoring, lifestyle modifications, and appropriate therapeutic interventions.

In the second paper, published in Liver International, we assessed nordicPRO-C3™ models to predict liver-related events in patients with a history of excessive alcohol use but without a confirmed diagnosis of chronic liver disease. Our findings our promising for improving risk stratification and clinical outcomes in alcohol-related liver disease.

A prospective cohort study involving patients with alcohol-related Liver Disease (ArLD), was conducted and divided into a derivation cohort of secondary care patients and a validation cohort of primary care patients. Baseline variables, including nordicPRO-C3™, were utilized to develop a prediction model known as the ALPACA score. The prognostic accuracy of the ALPACA score was compared to existing tools such as the enhanced liver fibrosis (ELF) test, FIB-4, TE, and the ADAPT score (developed for fatty liver disease).

The ALPACA score demonstrated excellent discriminative accuracy in both the derivation and validation cohorts, comparable to TE and the ELF test, and superior to FIB-4, nordicPRO-C3™ alone, and the ADAPT score. Importantly, the ALPACA score provided reliable prognostic performance independent of the baseline fibrosis stage. This breakthrough has the potential to revolutionize risk stratification and patient management in primary and secondary care settings.

NordicPRO-C3™ has recently become available on the Roche-COBAS high-precision platform, paving the way for its commercial availability worldwide in the near future. This accessibility will enable widespread adoption of nordicPRO-C3™-based scores, leading to improved risk prediction and better outcomes for individuals.