Roche introduces innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity
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.
Roche (RHHBY) ha lanciato il innovativo test Elecsys PRO-C3 per valutare la gravità della fibrosi epatica nei pazienti con malattia epatica steatosica associata a disfunzione metabolica (MASLD). Il test, sviluppato in collaborazione con Nordic Bioscience, fornisce risultati in soli 18 minuti sugli analizzatori cobas di Roche. Utilizzato insieme alla formula ADAPT, che considera età, stato diabetico, livelli di PRO-C3 e conta piastrinica, è in grado di distinguere tra diversi gradi di fibrosi.
La MASLD colpisce circa il 30% della popolazione ed è responsabile di circa un decesso ogni 25 a livello globale. Il nuovo test risponde a un bisogno cruciale, poiché la fibrosi epatica spesso rimane asintomatica fino agli stadi avanzati. Roche prevede di lanciare entro quest’anno un software per automatizzare il calcolo del punteggio ADAPT, semplificando ulteriormente il processo diagnostico.
Roche (RHHBY) ha lanzado la innovadora prueba Elecsys PRO-C3 para evaluar la gravedad de la fibrosis hepática en pacientes con enfermedad hepática esteatósica asociada a disfunción metabólica (MASLD). La prueba, desarrollada junto con Nordic Bioscience, ofrece resultados en solo 18 minutos en los analizadores cobas de Roche. Usada con la fórmula ADAPT, que considera la edad, el estado diabético, los niveles de PRO-C3 y el recuento de plaquetas, puede distinguir entre diferentes grados de fibrosis.
La MASLD afecta aproximadamente al 30% de la población y es responsable de aproximadamente una de cada 25 muertes a nivel mundial. La nueva prueba cubre una necesidad crítica, ya que la fibrosis hepática a menudo permanece asintomática hasta etapas avanzadas. Roche planea lanzar software a finales de este año para automatizar el cálculo del puntaje ADAPT, facilitando aún más el proceso diagnóstico.
로슈(RHHBY)는 대사 기능 장애와 관련된 지방간 질환(MASLD) 환자의 간 섬유증 중증도를 평가하는 혁신적인 Elecsys PRO-C3 검사를 출시했습니다. Nordic Bioscience와 공동 개발한 이 검사는 로슈의 cobas 분석기에서 단 18분 만에 결과를 제공합니다. 나이, 당뇨병 상태, PRO-C3 수치, 혈소판 수를 고려하는 ADAPT 공식과 함께 사용하면 다양한 섬유증 중증도를 구별할 수 있습니다.
MASLD는 전 세계 인구의 약 30%에 영향을 미치며, 전 세계 사망 원인 중 25건 중 1건에 해당합니다. 이 새로운 검사는 간 섬유증이 종종 증상이 없을 때까지 진행된다는 점에서 중요한 필요를 충족합니다. 로슈는 올해 말 ADAPT 점수 계산을 자동화하는 소프트웨어를 출시해 진단 과정을 더욱 간소화할 계획입니다.
Roche (RHHBY) a lancé le test innovant Elecsys PRO-C3 pour évaluer la gravité de la fibrose hépatique chez les patients atteints de maladie hépatique stéatosique associée à une dysfonction métabolique (MASLD). Ce test, développé avec Nordic Bioscience, fournit des résultats en seulement 18 minutes sur les analyseurs cobas de Roche. Utilisé avec la formule ADAPT, qui prend en compte l’âge, le statut diabétique, les niveaux de PRO-C3 et le nombre de plaquettes, il permet de distinguer différents degrés de fibrose.
La MASLD touche environ 30 % de la population et est responsable d’environ un décès sur 25 dans le monde. Ce nouveau test répond à un besoin crucial, car la fibrose hépatique reste souvent asymptomatique jusqu’aux stades avancés. Roche prévoit de lancer un logiciel d’ici la fin de l’année pour automatiser le calcul du score ADAPT, simplifiant ainsi davantage le processus diagnostique.
Roche (RHHBY) hat den innovativen Elecsys PRO-C3 Test zur Beurteilung des Schweregrads der Leberfibrose bei Patienten mit metabolisch bedingter Steatose-Lebererkrankung (MASLD) eingeführt. Der Test, entwickelt in Zusammenarbeit mit Nordic Bioscience, liefert Ergebnisse in nur 18 Minuten auf den cobas-Analysatoren von Roche. In Kombination mit der ADAPT-Formel, die Alter, Diabetesstatus, PRO-C3-Spiegel und Thrombozytenzahl berücksichtigt, kann er verschiedene Fibrosegrade unterscheiden.
MASLD betrifft etwa 30 % der Bevölkerung und ist weltweit für etwa einen von 25 Todesfällen verantwortlich. Der neue Test deckt einen dringenden Bedarf ab, da Leberfibrose oft bis zu fortgeschrittenen Stadien asymptomatisch bleibt. Roche plant, noch in diesem Jahr eine Software zur Automatisierung der ADAPT-Score-Berechnung einzuführen, die den Diagnoseprozess weiter vereinfacht.
- 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
- 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
"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.
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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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