Burning Rock Receives Japanese Approval for New Cancer Diagnostic
Innovative Developments in Cancer Diagnostics
Burning Rock Biotech Limited (NASDAQ: BNR) has recently achieved a significant milestone by receiving approval for its OncoGuide™ OncoScreen™ Plus CDx System in Japan. This innovative system is set to serve as a companion diagnostic for AstraZeneca’s capivasertib, marking a pivotal step forward in precision medicine for breast cancer.
Understanding the OncoGuide™ OncoScreen™ Plus CDx System
This advanced CDx System combines a sophisticated diagnostic kit and a specialized analysis program, tailored for next-generation sequencing (NGS). It facilitates the detection of critical genetic alterations, specifically targeting the PIK3CA, AKT1, and PTEN genes in a single test. Such capabilities are crucial for informing treatment decisions for adult patients struggling with unresectable or recurrent hormone-receptor (HR)-positive, HER2-negative breast cancer.
Impact on Breast Cancer Treatment
The approval of the OncoGuide™ OncoScreen™ Plus CDx System is especially significant as it supports the selection of patients eligible for capivasertib in combination with fulvestrant. With this system, the landscape of breast cancer treatment in Japan is poised to change dramatically, enhancing access to precise diagnostics for patients.
Future of Cancer Care in Japan
With the launch of this diagnostic tool, Riken Genesis Co., Ltd. is taking proactive steps to secure insurance coverage, ensuring that all eligible patients can benefit from timely and equitable access to this promising technology. The implications for breast cancer treatment are profound, with the potential to optimize therapeutic strategies and improve patient outcomes.
Leadership Commentary
Yusheng Han, the Founder and CEO of Burning Rock, expressed enthusiasm about the approval, highlighting it as a significant achievement in the company's global strategy. He noted that the capabilities of the OncoGuide™ System are designed to improve clinical treatment pathways and ultimately enhance patient care. Additionally, he mentioned that efforts are underway to secure registration for the product in China, aiming to broaden its reach to more breast cancer patients.
Achievements of Riken Genesis and Burning Rock
Yuko Oi, President and CEO of Riken Genesis, reflected on the partnership with Burning Rock, describing the approval as an exciting advancement in their joint mission to expand treatment options for breast cancer patients in Japan. Their commitment to delivering innovative diagnostic solutions underscores the potential for improving patient care through scientific collaboration.
About Riken Genesis Co., Ltd.
Founded in 2007, Riken Genesis is at the forefront of genetic testing and personalized medicine, utilizing cutting-edge gene analysis technologies. They hold CLIA certification, setting high standards in the provision of reliable testing services.
Burning Rock's Comprehensive Approach to Precision Oncology
As a leader in the field, Burning Rock Biotech Limited specializes in the application of NGS technology in precision oncology. Their service offerings span NGS-based therapy selection, global pharmaceutical services for biomarker detection, and early cancer detection innovations. Their commitment to patient care is reflected in their numerous successful developments, including NMPA-approved kits and breakthrough device designations from both US FDA and China NMPA.
Contact Information
For more information on Riken Genesis, you can reach out to Tatsuro Saito, General Manager in the Marketing Department, at +81-3-5759-6042 or via email at info2@rikengenesis.jp. For inquiries related to Burning Rock, customers can contact PBD@brbiotech.com.
Frequently Asked Questions
What is the OncoGuide™ OncoScreen™ Plus CDx System?
The OncoGuide™ OncoScreen™ Plus CDx System is a diagnostic tool that detects specific genetic alterations relevant for treating breast cancer.
What are its primary applications?
This system assists in identifying patients who are candidates for capivasertib, a targeted therapy for certain breast cancer types.
What does the approval signify for breast cancer patients?
This approval signifies better access to precision diagnostics and potential for enhanced treatment options, ultimately leading to improved patient outcomes.
Who is the manufacturer of this system?
The system is manufactured by Guangzhou Burning Rock Dx Co., Ltd., a subsidiary of Burning Rock.
How does Burning Rock contribute to cancer research?
Burning Rock is dedicated to advancing precision oncology through innovative testing, global pharmaceutical services, and early cancer detection initiatives.
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