Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer
Roche has achieved a significant milestone as the FDA grants Breakthrough Device Designation for its VENTANA TROP2 RxDx Device, marking the first AI-driven companion diagnostic for non-small cell lung cancer (NSCLC).
The innovative device combines immunohistochemistry assay with digital pathology algorithms to analyze NSCLC tissue samples and compute quantitative TROP2 scores. It integrates AstraZeneca's Quantitative Continuous Scoring platform, enabling unprecedented diagnostic precision compared to traditional manual methods.
This breakthrough could accelerate the availability of TROP2 CDx AI-driven system, helping identify NSCLC patients who may benefit from treatment with DATROWAY, a TROP2-directed antibody drug conjugate jointly developed by AstraZeneca and Daiichi Sankyo.
The system includes:
- TROP2 algorithm
- navify Digital Pathology Image Management System
- Roche Digital Pathology scanners
- VENTANA TROP2 RxDx Assay with OptiView DAB Detection Kit
Roche ha raggiunto un traguardo importante con l'assegnazione da parte della FDA della Designazione di Dispositivo Innovativo per il suo dispositivo VENTANA TROP2 RxDx, il primo diagnostico complementare basato su intelligenza artificiale per il carcinoma polmonare non a piccole cellule (NSCLC).
Il dispositivo innovativo combina un test di immunoistochimica con algoritmi di patologia digitale per analizzare i campioni di tessuto NSCLC e calcolare punteggi quantitativi TROP2. Integra la piattaforma di punteggio continuo quantitativo di AstraZeneca, offrendo una precisione diagnostica senza precedenti rispetto ai metodi manuali tradizionali.
Questa innovazione potrebbe accelerare la disponibilità del sistema CDx TROP2 basato su AI, aiutando a identificare i pazienti con NSCLC che potrebbero beneficiare del trattamento con DATROWAY, un coniugato anticorpo-farmaco diretto contro TROP2 sviluppato congiuntamente da AstraZeneca e Daiichi Sankyo.
Il sistema comprende:
- Algoritmo TROP2
- Sistema di gestione delle immagini di patologia digitale navify
- Scanner di patologia digitale Roche
- Test VENTANA TROP2 RxDx con kit di rilevamento OptiView DAB
Roche ha alcanzado un hito importante con la concesión por parte de la FDA de la Designación de Dispositivo Innovador para su dispositivo VENTANA TROP2 RxDx, marcando el primer diagnóstico complementario impulsado por IA para el cáncer de pulmón no microcítico (NSCLC).
El dispositivo innovador combina un ensayo de inmunohistoquímica con algoritmos de patología digital para analizar muestras de tejido de NSCLC y calcular puntuaciones cuantitativas de TROP2. Integra la plataforma de puntuación continua cuantitativa de AstraZeneca, permitiendo una precisión diagnóstica sin precedentes en comparación con métodos manuales tradicionales.
Este avance podría acelerar la disponibilidad del sistema CDx TROP2 impulsado por IA, ayudando a identificar a los pacientes con NSCLC que podrían beneficiarse del tratamiento con DATROWAY, un conjugado anticuerpo-fármaco dirigido a TROP2 desarrollado conjuntamente por AstraZeneca y Daiichi Sankyo.
El sistema incluye:
- Algoritmo TROP2
- Sistema de gestión de imágenes de patología digital navify
- Escáneres de patología digital Roche
- Ensayo VENTANA TROP2 RxDx con kit de detección OptiView DAB
로슈가 FDA로부터 혁신 의료기기 지정(Breakthrough Device Designation)을 획득하며, 비소세포폐암(NSCLC) 최초의 AI 기반 동반진단기기인 VENTANA TROP2 RxDx 디바이스를 선보였습니다.
이 혁신적인 기기는 면역조직화학 검사와 디지털 병리 알고리즘을 결합하여 NSCLC 조직 샘플을 분석하고 정량적 TROP2 점수를 산출합니다. 또한 AstraZeneca의 정량적 연속 점수 플랫폼을 통합하여 기존 수동 방식에 비해 전례 없는 진단 정밀도를 제공합니다.
이번 혁신은 AI 기반 TROP2 CDx 시스템의 조기 상용화를 앞당길 수 있으며, AstraZeneca와 Daiichi Sankyo가 공동 개발한 TROP2 표적 항체약물접합체 DATROWAY 치료가 필요한 NSCLC 환자 선별에 도움을 줄 것으로 기대됩니다.
시스템 구성요소는 다음과 같습니다:
- TROP2 알고리즘
- navify 디지털 병리 이미지 관리 시스템
- 로슈 디지털 병리 스캐너
- VENTANA TROP2 RxDx 분석법과 OptiView DAB 검출 키트
Roche a franchi une étape importante avec l'obtention par la FDA de la désignation de dispositif révolutionnaire pour son dispositif VENTANA TROP2 RxDx, marquant le premier diagnostic compagnon piloté par IA pour le cancer du poumon non à petites cellules (NSCLC).
Ce dispositif innovant combine un test d'immunohistochimie avec des algorithmes de pathologie numérique pour analyser les échantillons de tissu NSCLC et calculer des scores quantitatifs TROP2. Il intègre la plateforme de notation continue quantitative d'AstraZeneca, offrant une précision diagnostique sans précédent par rapport aux méthodes manuelles traditionnelles.
Cette avancée pourrait accélérer la disponibilité du système CDx TROP2 piloté par IA, aidant à identifier les patients atteints de NSCLC susceptibles de bénéficier d'un traitement par DATROWAY, un conjugué anticorps-médicament dirigé contre TROP2 développé conjointement par AstraZeneca et Daiichi Sankyo.
Le système comprend :
- Algorithme TROP2
- Système de gestion d’images de pathologie numérique navify
- Scanners de pathologie numérique Roche
- Test VENTANA TROP2 RxDx avec kit de détection OptiView DAB
Roche hat einen bedeutenden Meilenstein erreicht, indem die FDA die Breakthrough Device Designation für das VENTANA TROP2 RxDx-Gerät erteilt hat – das erste KI-gesteuerte Begleitdiagnostikum für nicht-kleinzelligen Lungenkrebs (NSCLC).
Das innovative Gerät kombiniert einen Immunhistochemie-Test mit digitalen Pathologie-Algorithmen, um NSCLC-Gewebeproben zu analysieren und quantitative TROP2-Werte zu berechnen. Es integriert die Quantitative Continuous Scoring-Plattform von AstraZeneca und ermöglicht dadurch eine bisher unerreichte diagnostische Genauigkeit im Vergleich zu herkömmlichen manuellen Methoden.
Dieser Durchbruch könnte die Verfügbarkeit des KI-gesteuerten TROP2 CDx-Systems beschleunigen und dabei helfen, NSCLC-Patienten zu identifizieren, die von einer Behandlung mit DATROWAY profitieren könnten – einem TROP2-gerichteten Antikörper-Wirkstoff-Konjugat, das gemeinsam von AstraZeneca und Daiichi Sankyo entwickelt wurde.
Das System umfasst:
- TROP2-Algorithmus
- navify Digital Pathology Image Management System
- Roche Digital Pathology Scanner
- VENTANA TROP2 RxDx-Assay mit OptiView DAB Detection Kit
- First AI-driven companion diagnostic device to receive FDA Breakthrough Device Designation for NSCLC
- Partnership with major pharmaceutical companies AstraZeneca and Daiichi Sankyo strengthens market position
- AI technology enables more precise diagnosis than traditional manual scoring methods
- Breakthrough designation could accelerate market availability and adoption
- Expands Roche's leadership in companion diagnostics and digital pathology
- None.
- The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment.
- The device uses artificial intelligence-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods.
- This Breakthrough Device Designation (BDD) demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology.
Basel, 29 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the VENTANA® TROP2 (EPR20043) RxDx Device. This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.
“This FDA Breakthrough Device Designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology,” said Matt Sause, CEO of Roche Diagnostics. “This solution, which leverages our industry-leading expertise in companion diagnostics development, uses artificial intelligence for a greater depth of sample analysis, helping to deliver truly personalised treatment.”
The VENTANA TROP2 (EPR20043) RxDx Device is a computational pathology device, consisting of the TROP2 algorithm, navify® Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200, DP 600) and the VENTANA TROP2 (EPR20043) RxDx Assay used with OptiView DAB Detection Kit for staining on a BenchMark ULTRA IHC/ISH staining instrument. The VENTANA TROP2 (EPR20043) RxDx Device analyses whole slide images of non-small cell lung cancer (NSCLC) tissue stained with TROP2 to compute a quantitative TROP2 score.
The algorithm incorporates AstraZeneca’s proprietary computational pathology platform, Quantitative Continuous Scoring (QCS), which enables a level of diagnostic precision not possible with traditional manual scoring methods.
“This FDA Breakthrough Device Designation underscores the potential of our computational pathology platform to enable more personalised treatment decisions for people with cancer,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.
The FDA granting Breakthrough Device Designation has the potential to make a TROP2 CDx AI-driven system available sooner, which could aid in identifying patients with NSCLC most likely to benefit from treatment with Daiichi Sankyo and AstraZeneca’s DATROWAY® (datopotamab deruxtecan-dlnk). DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.
About the VENTANA TROP2 (EPR20043) RxDx Device
The VENTANA TROP2 (EPR20043) RxDx Device is indicated as an aid in identifying patients with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alteration (AGA) most likely to benefit from treatment with Daiichi Sanko and AstraZeneca’s DATROWAY (datopotamab deruxtecan-dlnk). A qualified pathologist is responsible for reviewing staining and image quality, as well as ensuring adequate tumor detection sensitivity and precision, in conjunction with histological examination, relevant clinical information, and proper controls.
Following the pathologist assessment, the nDP TROP2 algorithm independently detects tumor cells and generates associated measures of TROP2 IHC staining intensity in both membrane and cytoplasm to compute the Normalised Membrane Ratio (NMR) score. The algorithm then classifies the TROP2 status as positive or negative based upon the pre-defined NMR cutoff.
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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