Burning Rock's OncoGuide™ OncoScreen™ Plus CDx System Now Approved in Japan as a Companion Diagnostic for Capivasertib in Breast Cancer
Burning Rock Biotech (NASDAQ: BNR) and Riken Genesis have received approval from Japan's MHLW for their OncoGuide™ OncoScreen™ Plus CDx System as a companion diagnostic for AstraZeneca's capivasertib in breast cancer treatment.
The CDx System is designed to detect PIK3CA, AKT1, and PTEN alterations in a single test, supporting treatment decisions for adult patients with unresectable or recurrent HR-positive, HER2-negative breast cancer who have progressed after endocrine therapy. The diagnostic will be used for patient selection for capivasertib in combination with fulvestrant.
Riken Genesis will proceed with insurance coverage preparations to ensure patient access, while Burning Rock is advancing the product's registration in China.
Burning Rock Biotech (NASDAQ: BNR) e Riken Genesis hanno ottenuto l'approvazione dal MHLW del Giappone per il loro OncoGuide™ OncoScreen™ Plus CDx System come diagnostico di accompagnamento per il capivasertib di AstraZeneca nel trattamento del cancro al seno. Il CDx System è progettato per rilevare alterazioni di PIK3CA, AKT1 e PTEN in un unico test, supportando le decisioni terapeutiche per pazienti adulti con cancro al seno HR-positivo, HER2-negativo non resecabile o recidivo che hanno progredito dopo la terapia endocrina. Il diagnostico sarà utilizzato per la selezione dei pazienti per capivasertib in associazione con fulvestrant. Riken Genesis procederà con le preparazioni per la copertura assicurativa per garantire l’accesso dei pazienti, mentre Burning Rock sta avanzando con la registrazione del prodotto in Cina.
Burning Rock Biotech (NASDAQ: BNR) y Riken Genesis han obtenido la aprobación del MHLW de Japón para su OncoGuide™ OncoScreen™ Plus CDx System como diagnóstico complementario para el capivasertib de AstraZeneca en el tratamiento del cáncer de mama. El CDx System está diseñado para detectar alteraciones de PIK3CA, AKT1 y PTEN en una sola prueba, apoyando las decisiones de tratamiento para pacientes adultos con cáncer de mama HR-positivo, HER2-negativo no resecable o recurrente que han progresado tras la terapia hormonal. El diagnóstico se utilizará para la selección de pacientes para capivasertib en combinación con fulvestrant. Riken Genesis procederá con los preparativos de cobertura de seguro para garantizar el acceso de los pacientes, mientras Burning Rock avanza con el registro del producto en China.
Burning Rock Biotech (NASDAQ: BNR) 와 Riken Genesis 는 일본 MHLW 의 승인을 받아 AstraZeneca 의 capivasertib 를 유방암 치료에 사용하는 동반 진단제인 OncoGuide™ OncoScreen™ Plus CDx System 을 받았습니다. CDx 시스템은 단일 검사로 PIK3CA, AKT1 및 PTEN 변이 를 감지하도록 설계되어, 내분비 치료 후 진행된 HR 양성, HER2 음성의 비절제 가능 혹은 재발 유방암 환자들의 치료 결정을 지원합니다. 이 진단은 fulvestrant 와의 병용에서 capivasertib 를 위한 환자 선별에 사용될 것입니다. Riken Genesis 는 환자 접근성을 보장하기 위한 보험 적용 준비를 진행하고, Burning Rock 은 중국 내 제품 등록을 진행 중입니다.
Burning Rock Biotech (NASDAQ: BNR) et Riken Genesis ont obtenu l’approbation du MHLW du Japon pour leur OncoGuide™ OncoScreen™ Plus CDx System en tant que diagnostic compagnon pour le capivasertib d’AstraZeneca dans le traitement du cancer du sein. Le système CDx est conçu pour détecter des altérations de PIK3CA, AKT1 et PTEN en un seul test, afin d’éclairer les décisions de traitement pour les patientes adultes atteintes d’un cancer du sein HR positif, HER2 négatif non résécable ou récurrent qui ont progressé après une thérapie endocrinienne. Le diagnostic sera utilisé pour la sélection des patientes pour le capivasertib en association avec le fulvestrant. Riken Genesis poursuivra les préparatifs de couverture d’assurance pour garantir l’accès des patientes, tandis que Burning Rock fait progresser l’enregistrement du produit en Chine.
Burning Rock Biotech (NASDAQ: BNR) und Riken Genesis haben die Genehmigung des japanischen MHLW für ihr OncoGuide™ OncoScreen™ Plus CDx System als Companion Diagnostics für Capivasertib von AstraZeneca in der Behandlung von Brustkrebs erhalten. Das CDx-System soll Alterationen von PIK3CA, AKT1 und PTEN in einem Test erkennen und Behandlungsempfehlungen für erwachsene Patientinnen und Patienten mit unresectablem oder rezidivem HR-positivem, HER2-negativem Brustkrebs unterstützen, die nach einer endokrinen Therapie fortgeschritten sind. Die Diagnostik wird zur Patientenauswahl für Capivasertib in Kombination mit Fulvestrant verwendet. Riken Genesis wird mit Vorbereitungen zur Krankenversicherungsdeckung fortfahren, um den Zugang der Patienten zu gewährleisten, während Burning Rock die Registrierung des Produkts in China vorantreibt.
Burning Rock Biotech (NASDAQ: BNR) و Riken Genesis حاصلا على موافقة وزارة الصحة والعمل اليابانية (MHLW) على نظام OncoGuide™ OncoScreen™ Plus CDx System كاختبار تشخيص مرافق للاستخدام مع capivasertib من أسترازينيكا في معالجة سرطان الثدي. يهدف النظام CDx إلى كشف تغيرات PIK3CA وAKT1 وPTEN في اختبار واحد، بما يدعم قرارات العلاج للمرضى البالغين المصابين بسرطان الثدي HR-إيجابي، HER2 سلبي غير قابل للإزالة أو متكرر الذي تقدم بعد العلاج الهرموني. سيستخدم التشخيص في اختيار المرضى للاستخدامCapivasertib مع fulvestrant. ستتابع Riken Genesis إجراءات تغطية التأمين لضمان وصول المرضى، بينما تتقدم Burning Rock في تسجيل المنتج في الصين.
Burning Rock Biotech（纳斯达克股票代码：BNR）与 Riken Genesis 已获得日本厚生劳动省（MHLW）批准，将其 OncoGuide™ OncoScreen™ Plus CDx System 作为阿斯利康 Capivasertib 在乳腺癌治疗中的伴随诊断。该 CDx 系统设计用于在单次检测中检测 PIK3CA、AKT1 和 PTEN 的改变，为已接受内分泌治疗后进展的成人 HR 阳性、HER2 阴性不能手术切除或复发的乳腺癌患者的治疗决策提供支持。该诊断将用于 Capivasertib 与 Fulvestrant 联合治疗的患者筛选。Riken Genesis 将推进保险覆盖的准备工作以确保患者获取，而 Burning Rock 正在推进该产品在中国的注册工作。
- Regulatory approval in Japan expands market presence for Burning Rock's diagnostic system
- CDx System enables detection of multiple gene alterations in a single test, improving efficiency
- Product registration process underway in China, indicating potential market expansion
- Partnership with established Japanese company Riken Genesis enhances market access
- None.
Insights
Burning Rock's companion diagnostic approval in Japan strengthens their international presence and creates new revenue opportunities in precision oncology.
The approval of Burning Rock's OncoGuide™ OncoScreen™ Plus CDx System in Japan represents a significant milestone for the company's global expansion strategy. This companion diagnostic (CDx) system is designed to identify specific genetic alterations (PIK3CA, AKT1, and PTEN) in breast cancer patients, helping clinicians select appropriate candidates for treatment with AstraZeneca's capivasertib in combination with fulvestrant.
What makes this approval particularly valuable is that it addresses an important clinical need in HR-positive, HER2-negative breast cancer patients who have progressed after endocrine therapy. The PI3K/AKT/PTEN pathway is frequently altered in this cancer subtype, and identifying these mutations in a single test can streamline the diagnostic process and expand treatment options.
From a market perspective, this approval gives Burning Rock entry into Japan's advanced healthcare market through their partnership with Riken Genesis. The companion diagnostic status creates a direct link to a specific therapy, which typically ensures more predictable adoption rates and reimbursement pathways compared to general diagnostic tools. The partnership with an established local company (Riken Genesis) and the connection to AstraZeneca's therapy suggests a well-structured commercialization strategy.
The mention of concurrent registration efforts in China indicates Burning Rock is pursuing a coordinated multi-market strategy for this diagnostic platform, potentially amplifying revenue opportunities across Asia's largest healthcare markets. This approval establishes Burning Rock as a player in the international precision oncology diagnostic space, moving beyond their home market.
TOKYO and GUANGZHOU, China, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Riken Genesis Co., Ltd. (Riken Genesis) and Burning Rock Biotech Limited (NASDAQ: BNR, “Burning Rock”) today announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca’s capivasertib has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW).
The CDx System is a combination medical device consisting of the OncoGuide™ OncoScreen™ Plus CDx Kit and the OncoGuide™ OncoScreen™ Plus CDx Analysis Program, designed to be used with a next-generation sequencer. It enables the detection of PIK3CA, AKT1, and PTEN alterations in a single test. This diagnostic tool is intended to guide treatment decisions for adult patients with unresectable or recurrent hormone-receptor (HR)-positive, HER2-negative breast cancer who have progressed following endocrine therapy and whose tumors carry one or more PIK3CA, AKT1, or PTEN gene alterations.
The approval of this CDx system supports the use for patient selection for capivasertib in combination with fulvestrant.
With the introduction of this CDx System into clinical practice, access to precision diagnostics for breast cancer patients in Japan is expected to improve, ultimately expanding therapeutic opportunities. Riken Genesis will begin preparations for insurance coverage, aiming to ensure timely and equitable access for all eligible patients.
Yusheng Han, Founder and CEO of Burning Rock, commented:
"We are delighted to collaborate with Riken Genesis to achieve the approval of the CDx System in Japan. This is a significant milestone in Burning Rock's global strategy. Research shows that this CDx System can assist in guiding clinical treatment for breast cancer, optimizing treatment plans, and enhancing patient outcomes. We are concurrently advancing the product's registration application in China, hoping that its approval there will benefit more breast cancer patients."
Yuko Oi, President and CEO of Riken Genesis, commented:
"We are honored to receive our first approval for a combination medical device product in partnership with Burning Rock. This achievement represents a promising step toward expanding treatment options for breast cancer patients in Japan. We are committed to delivering this innovative diagnostic tool to patients as quickly as possible."
Notes
1 Combination Medical Device:
A combination of two or more types of items (pharmaceuticals, medical devices or regenerative medicines) constituting a medical device to be manufactured and marketed.
2 Companion diagnostics:
Clinical testing performed to predict the efficacy and side effects of drugs before using them for treatment, particularly testing that is performed at the same time as pharmaceutical development.
About OncoGuide™ OncoScreen™ Plus CDx System
| (1) Product name | OncoGuide™ OncoScreen™ Plus CDx System | ||
| (2) Approval No. | 30700BZX00235000 | ||
| (3) Components | a combination medical device | ||
| OncoGuide™ OncoScreen™ Plus CDx Kit | |||
| OncoGuide™ OncoScreen™ Plus CDx Analysis Program | |||
| (4) Testing method | Next-Generation Sequencing (NGS) | ||
| (5) Specimen | DNA extracted from FFPE tumor tissue | ||
| (6) Purpose of use | This CDx System is intended to detect relevant genetic alterations to assist in determining the indications for the pharmaceutical products listed below. | ||
| Gene | Indication | Drug Trade Name (Generic) | |
| AKT1 | Breast Cancer | Truqap® (Capivasertib) | |
| PIK3CA | |||
| PTEN | |||
| (7) Marketing Authorization Holder | Riken Genesis Co., Ltd. | ||
| (8) Manufacturer | Guangzhou Burning Rock Dx Co., Ltd.* | ||
* Guangzhou Burning Rock Dx Co., Ltd is a variable interest entity’s subsidiary of Burning Rock.
About Riken Genesis Co., Ltd.
RIKEN GENESIS, founded in October 2007, provides lab-assay services as well as products for genetic testing based on cutting-edge gene analysis technologies and bioinformatics, and has experience in the field of personalized medicine. The company provides highly reliable tests based on international quality standards, as demonstrated by its CLIA certification, being the first organization in Japan to meet this U.S. quality control standard for clinical laboratories.
For more information, please visit: https://www.rikengenesis.jp
About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of 1) NGS-based therapy selection testing for late-stage cancer patients, 2) Global pharmaceutical services on biomarker detection and companion diagnostics development, and 3) Early cancer detection which has moved beyond proof-of-concept R&D into the clinical validation stage. Burning Rock provides dedicated services to pharmaceutical partners, encompassing genomic data solutions, clinical trial solutions, precision patient recruitment, and companion diagnostics development and commercialization. Burning Rock has achieved two NMPA-approved IVD kits, four assays with CE marking, and a breakthrough device designation (BDD) received from both US FDA and China NMPA for multi-cancer detection blood test.
For more information about Burning Rock, please visit: https://www.brbiotech.com
Contact:
Tatsuro Saito
General Manager, Marketing department
Tel: +81-3-5759-6042
info2@rikengenesis.jp
Contact:
PBD@brbiotech.com
IR@brbiotech.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cb8b2cfa-f5fa-4dc5-b585-f3539f41af76
FAQ
What is the OncoGuide™ OncoScreen™ Plus CDx System approved for in Japan?
Which breast cancer patients are eligible for testing with Burning Rock's (BNR) diagnostic system?
What genetic alterations does the BNR OncoScreen Plus CDx System detect?
When will Burning Rock's OncoScreen Plus CDx System be available in Japan?
Is Burning Rock (BNR) planning to launch the OncoScreen Plus CDx System in other markets?
