Burning Rock Biotech Ltd. and Riken Genesis Secure Japan's Approval for OncoScreen™ Plus CDx System as Companion Diagnostic for Breast Cancer Treatment

Reuters

09/24

<a href="https://laohu8.com/S/BNR">Burning Rock Biotech</a> Ltd. and Riken Genesis Secure Japan's Approval for OncoScreen™ Plus CDx System as Companion Diagnostic for Breast <a href="https://laohu8.com/S/CTHZ">Cancer Treatment</a>

Burning Rock Biotech Ltd. has announced that its OncoGuide™ OncoScreen™ Plus CDx System has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW) as a companion diagnostic for AstraZeneca's capivasertib in breast cancer. This approval, achieved in partnership with Riken Genesis, marks the first for a combination medical device product by the two companies. The CDx System is designed to guide treatment decisions for adult patients with unresectable or recurrent hormone-receptor $(HR)$-positive, HER2-negative breast cancer by detecting PIK3CA, AKT1, and PTEN gene alterations. The system's approval supports patient selection for capivasertib in combination with fulvestrant, aiming to improve precision diagnostics and expand therapeutic opportunities for breast cancer patients in Japan.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Burning Rock Biotech Ltd. published the original content used to generate this news brief on September 24, 2025, and is solely responsible for the information contained therein.

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This approval, achieved in partnership with Riken Genesis, marks the first for a combination medical device product by the two companies. The CDx System is designed to guide treatment decisions for adult patients with unresectable or recurrent hormone-receptor <a href=\"https://laohu8.com/S/HR\">$(HR)$</a>-positive, HER2-negative breast cancer by detecting PIK3CA, AKT1, and PTEN gene alterations. The system's approval supports patient selection for capivasertib in combination with fulvestrant, aiming to improve precision diagnostics and expand therapeutic opportunities for breast cancer patients in Japan.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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This approval, achieved in partnership with Riken Genesis, marks the first for a combination medical device product by the two companies. The CDx System is designed to guide treatment decisions for adult patients with unresectable or recurrent hormone-receptor <a href=\"https://laohu8.com/S/HR\">$(HR)$</a>-positive, HER2-negative breast cancer by detecting PIK3CA, AKT1, and PTEN gene alterations. The system's approval supports patient selection for capivasertib in combination with fulvestrant, aiming to improve precision diagnostics and expand therapeutic opportunities for breast cancer patients in Japan.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Burning Rock Biotech Ltd. published the original content used to generate this news brief on September 24, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0496365809.HKD","symbol_name":"TEMPLETON GLOBAL INCOME \"A\" (HKD) INC (Q)","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250924:nNDL7sXyDh:1","article_id":"2569472791","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2569472791","pubTimestamp":1758693439,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Burning Rock Biotech Ltd. and Riken Genesis Secure Japan's Approval for OncoScreen Plus CDx System as Companion Diagnostic for Breast Cancer Treatment. 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