Roche Launches Innovative Blood Test for Liver Fibrosis Assessment

Roche has introduced a groundbreaking diagnostic tool aimed at revolutionizing the assessment of liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The Elecsys PRO-C3 blood test, designed to run on Roche's cobas e instruments, offers a rapid and non-invasive method for evaluating liver disease severity, potentially reducing the need for invasive biopsies.

A New Era in Liver Disease Diagnostics

The Elecsys PRO-C3 test measures the levels of PRO-C3, a biomarker released during the formation of fibrotic scarring in the liver. This 18-minute test is used in conjunction with a clinical formula that incorporates factors such as the patient's age, diabetes status, and platelet count to calculate an ADAPT score. This comprehensive approach provides healthcare providers with a clearer picture of liver health and fibrosis progression.

Matt Sause, CEO of Roche Diagnostics, emphasized the test's significance: "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."

Addressing a Global Health Concern

MASLD, formerly known as non-alcoholic fatty liver disease (NAFLD), affects approximately 30% of the world's population. The condition can progress to metabolic dysfunction-associated steatohepatitis (MASH), characterized by liver inflammation and scarring that can compromise organ function.

The PRO-C3 biomarker has demonstrated its utility in predicting disease progression in various liver conditions, including hepatitis C. Roche's new test can categorize patients by fibrosis severity, including moderate fibrosis, severe fibrosis, and late-stage cirrhosis. This capability is crucial, as liver fibrosis contributes to about one in every 25 deaths globally.

Implications for Treatment and Drug Development

The launch of the Elecsys PRO-C3 test comes at a pivotal time in liver disease treatment. In March of the previous year, the FDA approved Madrigal Pharmaceuticals' Rezdiffra (resmetirom) as the first drug specifically designed to treat MASH in patients with moderate to severe fibrosis. This approval has opened up a significant new market for treatments targeting this unmet medical need.

Roche's diagnostic innovation is poised to play a crucial role in identifying suitable candidates for emerging therapies and monitoring treatment efficacy. The company plans to release software later this year to automate the calculation of ADAPT scores, further streamlining the diagnostic process and enhancing its utility in clinical settings.