Riken Genesis and Burning Rock's OncoGuide™ OncoScreen™ Plus CDx System receives approval in Japan for breast cancer treatment diagnostics.
Quiver AI Summary
Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that their OncoGuide™ OncoScreen™ Plus CDx System has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare. This diagnostic tool, which involves a kit and an analysis program for next-generation sequencing, is designed to identify PIK3CA, AKT1, and PTEN gene alterations in patients with unresectable or recurrent hormone-receptor positive, HER2-negative breast cancer. The system supports treatment decisions for patients who have not responded to endocrine therapy and will be used with AstraZeneca's capivasertib. The approval is expected to enhance access to precision diagnostics for breast cancer patients in Japan, with Riken Genesis working on insurance coverage to ensure accessibility. Both companies emphasized the significance of this approval for patient outcomes and ongoing efforts to expand the product's availability in China.
Potential Positives
- The OncoGuide™ OncoScreen™ Plus CDx System has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare, marking a significant regulatory milestone for Riken Genesis and enhancing its product portfolio.
- This CDx System is expected to improve access to precision diagnostics for breast cancer patients in Japan, ultimately expanding therapeutic opportunities.
- The collaboration with Burning Rock Biotech demonstrates Riken Genesis's commitment to innovation and partnership in the healthcare sector, which may strengthen its market position.
- Preparations for insurance coverage to ensure timely access for eligible patients highlight the company's dedication to patient care and accessibility in healthcare services.
Potential Negatives
- The press release does not provide specific information about the expected timeline for the product's market launch or insurance coverage preparation, leading to uncertainty regarding when patients can actually access the diagnostic tool.
- It mentions concurrent advancement of the product's registration application in China, but does not address potential regulatory hurdles or delays in that market, which could impact global strategy and timelines.
- There is a lack of detailed data regarding the clinical efficacy and safety of the OncoGuide™ OncoScreen™ Plus CDx System, which might raise concerns among healthcare providers about integrating it into clinical practice.
FAQ
What is the OncoGuide™ OncoScreen™ Plus CDx System?
The OncoGuide™ OncoScreen™ Plus CDx System is a diagnostic tool for detecting genetic alterations in breast cancer patients.
Who developed the OncoGuide™ OncoScreen™ Plus CDx System?
The system was developed through collaboration between Riken Genesis Co., Ltd. and Burning Rock Biotech Limited.
What is the purpose of this CDx System?
This CDx System assists in treatment decisions for breast cancer patients who have specific gene alterations after endocrine therapy.
What does the approval from Japan's MHLW mean?
The approval allows the OncoGuide™ OncoScreen™ Plus CDx System to be manufactured and marketed in Japan.
When will the CDx System be available for patients?
Riken Genesis is preparing for insurance coverage to ensure equitable access for eligible patients as soon as possible.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
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
[email protected]
Contact:
[email protected]
[email protected]
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cb8b2cfa-f5fa-4dc5-b585-f3539f41af76
