Roche introduces innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity

Rhea-AI Summary

Roche (RHHBY) has launched the innovative Elecsys PRO-C3 test for assessing liver fibrosis severity in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The test, developed with Nordic Bioscience, delivers results in just 18 minutes on Roche's cobas analysers. When used with the ADAPT formula, which considers age, diabetes status, PRO-C3 levels, and platelet count, it can distinguish between different fibrosis severities.

MASLD affects approximately 30% of the population and is responsible for about one in every 25 deaths globally. The new test addresses a critical need as liver fibrosis often remains asymptomatic until advanced stages. Roche plans to launch software later this year to automate the ADAPT score calculation, further streamlining the diagnostic process.

Positive

• Fast results delivery in just 18 minutes, improving diagnostic efficiency
• Simplifies diagnostic process with a single assay, reducing costs and need for invasive biopsies
• Addresses large market opportunity with MASLD affecting 30% of population
• Positions Roche to benefit from emerging liver fibrosis drug treatments market
• Planned software launch for automated calculations will further enhance the product offering

Negative

• Initial ADAPT score requires manual calculation until software launch
• Market adoption may depend on healthcare providers' willingness to switch from current testing methods

• Elecsys PRO-C3, used with the ADAPT formula (age, diabetes status, PRO-C3, platelets), assesses liver fibrosis severity – a disease responsible for approximately one in every 25 deaths worldwide¹
• The test delivers results in just 18 minutes on Roche’s cobas analysers, providing a fast and reliable diagnostic method.
• The test enables earlier identification of patients with significant liver fibrosis, potentially improving outcomes through timely management and access to emerging therapies.

Basel, 06 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its Elecsys® PRO-C3 test, a new diagnostic solution designed to assess the severity of liver fibrosis in patients showing signs of metabolic dysfunction–associated steatotic liver disease (MASLD). The test, developed in partnership with Nordic Bioscience, offers clinicians a simple and efficient method of identifying patients with liver fibrosis of varying severity, enabling timely intervention and appropriate management of the disease.

MASLD affects around 30% of the population,² and is one of the most common causes of chronic liver disease in the developed world.³  Caused mainly by diabetes, obesity and other cardiometabolic risk factors,³ a rapidly growing number of people are living with MASLD, representing a significant burden for patients and health systems worldwide. However, despite being responsible for approximately one in every 25 deaths globally,¹ the liver fibrosis associated with MASLD is often asymptomatic until the advanced stages and can go undetected for years. Unmanaged, it can lead to severe consequences such as cirrhosis, liver cancer, and liver failure.

"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 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."

Until recently, no medicines were available to treat MASLD, and disease management options were focused on lifestyle interventions such as diet and exercise. New drug treatments for liver fibrosis are now emerging, giving clinicians, for the first time, a means of improving liver function and slowing disease progression.

The Elecsys PRO-C3 test requires only a single assay, which delivers results in only 18 minutes on Roche’s cobas® analysers. This streamlines the process compared to currently available tests and reduces costs. Used in combination with the ADAPT formula,⁴ which includes PRO-C3 levels, platelet count, age and diabetes status, it provides a clear assessment of the severity of fibrosis, including distinguishing 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.

Initially, the ADAPT score will be calculated manually. Later this year, Roche is planning to launch software that will automate the calculation and further streamline liver fibrosis diagnosis.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science-Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Younossi ZM, Golabi P, Paik JM, Henry A, Van Dongen C, Henry L. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology. 2023 Apr 1;77(4)1335-1347.
[2] Riazi et al. 2022,The prevalence and incidence of NAFLD worldwide: a systematic review and meta-analysis, The Lancet Gastroenterology & Hepatology 2022 Sep;7(9):851-861. doi: 10.1016/S2468-1253(22)00165-0. Epub 2022 Jul 5. PMID: 35798021.
[3] EASL Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol 2024; 81(3): 492-542.
[4] Daniels SJ, et al. ADAPT: An Algorithm Incorporating PRO-C3 Accurately Identifies Patients With NAFLD and Advanced Fibrosis. Hepatology. 2019 Mar;69(3):1075-1086. doi: 10.1002/hep.30163. PMID: 30014517.

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FAQ

What is the new Elecsys PRO-C3 test by Roche (RHHBY) and how does it work?

The Elecsys PRO-C3 is a diagnostic test that assesses liver fibrosis severity in MASLD patients. It works in combination with the ADAPT formula, considering PRO-C3 levels, age, diabetes status, and platelet count, delivering results in 18 minutes on Roche's cobas analysers.

What are the advantages of Roche's new liver fibrosis test over existing methods?

The test provides faster results (18 minutes), requires only a single assay, reduces costs, and minimizes the need for invasive biopsies. It can also distinguish between different fibrosis severities, helping determine appropriate treatment pathways.

How significant is the market opportunity for Roche's Elecsys PRO-C3 test?

The market opportunity is substantial as MASLD affects around 30% of the population and causes approximately one in every 25 deaths globally, representing a significant burden for healthcare systems.

When will Roche launch the automated ADAPT score calculation software?

Roche plans to launch the software for automated ADAPT score calculation later in 2025, which will further streamline the liver fibrosis diagnosis process.

What conditions can Roche's Elecsys PRO-C3 test detect?

The test can identify different severities of liver fibrosis, including significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD).