Burning Rock's OncoGuide™ OncoScreen™ Plus CDx System Receives Approval in Japan as a Companion Diagnostic for Capivasertib in Breast Cancer Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 23 2025
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Source: Globenewswire
Approval Announcement: 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 for use as a companion diagnostic for AstraZeneca’s capivasertib in breast cancer treatment.
Diagnostic Capabilities: The CDx System detects genetic alterations in PIK3CA, AKT1, and PTEN, aiding treatment decisions for patients with unresectable or recurrent hormone-receptor-positive, HER2-negative breast cancer who have progressed after endocrine therapy.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
