Riken Genesis Co., Ltd. and Burning Rock Biotech Limited (NASDAQ: BNR) announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted Manufacturing and Marketing Approval for the OncoGuide™ OncoScreen™ Plus CDx System as a companion diagnostic for AstraZeneca's capivasertib. The approval represents a significant milestone in precision oncology diagnostics for breast cancer treatment in Japan.
Next-Generation Sequencing Technology for Precision Medicine
The OncoGuide™ OncoScreen™ Plus CDx System is a combination medical device comprising the OncoGuide™ OncoScreen™ Plus CDx Kit and the OncoGuide™ OncoScreen™ Plus CDx Analysis Program, designed for use with next-generation sequencing technology. The system enables detection of PIK3CA, AKT1, and PTEN alterations in a single test using DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue.
The diagnostic tool is specifically 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 supports patient selection for capivasertib in combination with fulvestrant therapy.
Clinical Impact and Market Access
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.
"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," said Yusheng Han, Founder and CEO of Burning Rock. "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."
Strategic Partnership and Future Expansion
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."
The approval marks Riken Genesis's first combination medical device approval and represents an important expansion of Burning Rock's global footprint. Burning Rock has previously achieved two NMPA-approved IVD kits, four assays with CE marking, and breakthrough device designations from both the US FDA and China NMPA for multi-cancer detection blood tests.
Company Backgrounds
Riken Genesis, founded in October 2007, provides lab-assay services and genetic testing products based on cutting-edge gene analysis technologies and bioinformatics. The company maintains international quality standards, demonstrated by its CLIA certification as the first organization in Japan to meet this U.S. quality control standard for clinical laboratories.
Burning Rock Biotech Limited focuses on applying next-generation sequencing technology in precision oncology, with business segments including NGS-based therapy selection testing for late-stage cancer patients, global pharmaceutical services on biomarker detection and companion diagnostics development, and early cancer detection moving from proof-of-concept research into clinical validation.
