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Roche launches rapid liver fibrosis test to transform MASLD diagnosis

Roche has introduced the Elecsys PRO-C3 test, a breakthrough diagnostic solution that delivers liver fibrosis severity assessment results in just 18 minutes, addressing a critical gap in managing metabolic dysfunction-associated steatotic liver disease (MASLD) that affects approximately 30% of the global population.

Streamlined diagnostic approach transforms patient care

The innovative test, developed in partnership with Nordic Bioscience, utilises a single assay on Roche’s cobas analysers to provide rapid, reliable liver fibrosis evaluation. When combined with the ADAPT formula incorporating age, diabetes status, PRO-C3 levels, and platelet count, clinicians can distinguish between significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4).

“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 treat-
ments 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.”

Critical timing as therapeutic landscape evolves

The launch comes at a pivotal moment as liver fibrosis, responsible for approximately one in every 25 deaths globally, transitions from a condition with limited treatment options to one with emerging therapeutic interventions. Previously, MASLD management focused primarily on lifestyle modifications, but new drug treatments are now providing clinicians with tools to improve liver function and slow disease progression.

Enhanced clinical workflow integration planned

Initially, healthcare providers will calculate ADAPT scores manually, but https://clinlabint.com/wp-admin/post-new.php#save Roche plans to introduce automated calculation software later this year to further streamline the diagnostic workflow. This progression reflects the company’s commitment to reducing healthcare system burden whilst improving diagnostic precision.

The test’s rapid turnaround time represents a significant advancement over current diagnostic approaches, enabling earlier identification of patients with significant liver fibrosis. This early detection capability is particularly crucial given that MASLD-associated liver fibrosis often remains asymptomatic until advanced stages, with unmanaged disease potentially progressing to severe consequences including cirrhosis, liver cancer, and liver failure.

For more information, visit: www.roche.com

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