Burning Rock's OncoGuide™ OncoScreen™ Plus CDx System Now Approved in Japan as a Companion Diagnostic for Capivasertib in Breast Cancer

Core Viewpoint - Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced the approval of the OncoGuide™ OncoScreen™ Plus CDx System in Japan, which will serve as a companion diagnostic for AstraZeneca's capivasertib, enhancing precision diagnostics for breast cancer patients [1][4][5]. Group 1: Product Details - The OncoGuide™ OncoScreen™ Plus CDx System is a combination medical device that includes the OncoGuide™ OncoScreen™ Plus CDx Kit and the OncoGuide™ OncoScreen™ Plus CDx Analysis Program, designed for use with next-generation sequencing [3][8]. - This diagnostic tool detects PIK3CA, AKT1, and PTEN alterations in a single test, aimed at guiding treatment decisions for adult patients with unresectable or recurrent hormone-receptor-positive, HER2-negative breast cancer [3][4]. Group 2: Market Impact - The approval of the CDx system is expected to improve access to precision diagnostics for breast cancer patients in Japan, ultimately expanding therapeutic opportunities [4]. - Riken Genesis plans to prepare for insurance coverage to ensure timely and equitable access for all eligible patients [4]. Group 3: Company Insights - Burning Rock's CEO highlighted that the approval is a significant milestone in the company's global strategy, emphasizing the system's role in optimizing treatment plans and enhancing patient outcomes [5]. - Riken Genesis expressed commitment to delivering the innovative diagnostic tool to patients as quickly as possible, marking their first approval for a combination medical device product [5][9].