Roche Holding AG Receives CE IVDR Approval for Expanded Use of VENTANA HER2 (4B5) Diagnostic Test in Breast and Biliary Tract Cancer

Reuters

Sep 05

Roche Holding AG Receives CE IVDR Approval for Expanded Use of VENTANA HER2 (4B5) Diagnostic Test in Breast and Biliary Tract Cancer

Roche Holding AG has announced that it has received CE IVDR approval for two label expansions of its VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* assay. This test is now approved to assist in the identification of metastatic breast cancer patients with HER2-ultralow status, making them potentially eligible for treatment with ENHERTU® (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca. Additionally, the test is approved for identifying patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer who may be eligible for treatment with ZIIHERA® (zanidatamab-hrii) by Jazz Pharmaceuticals. Roche's expanded approval aims to enhance personalized treatment options for patients facing challenging cancers.

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. Roche Holding AG published the original content used to generate this news brief via PR Newswire (Ref. ID: SF65914) on September 05, 2025, and is solely responsible for the information contained therein.

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This test is now approved to assist in the identification of metastatic breast cancer patients with HER2-ultralow status, making them potentially eligible for treatment with ENHERTU® (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate developed by <a href=\"https://laohu8.com/S/DSKY\">Daiichi Sankyo</a> and AstraZeneca. Additionally, the test is approved for identifying patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer who may be eligible for treatment with ZIIHERA® (zanidatamab-hrii) by Jazz Pharmaceuticals. Roche's expanded approval aims to enhance personalized treatment options for patients facing challenging cancers.\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. Roche Holding AG published the original content used to generate this news brief via PR Newswire (Ref. ID: SF65914) on September 05, 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":"LU0976567544.SGD","symbol_name":"FTIF - Templeton Global Income A Mdis SGD-H1","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250905:nNDL5m38ZQ:1","article_id":"2565395015","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2565395015","pubTimestamp":1757048424,"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":"Roche Holding AG Receives CE IVDR Approval for Expanded Use of VENTANA HER2  Diagnostic Test in Breast and Biliary Tract Cancer. Roche Holding AG has announced that it has received CE IVDR approval for two label expansions of its VENTANA HER2  Rabbit Monoclonal Primary Antibody RxDx* assay. This test is now approved to assist in the identification of metastatic breast cancer patients with HER2-ultralow status, making them potentially eligible for treatment with ENHERTU , a HER2-directed antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca. Additionally, the test is approved for identifying patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer who may be eligible for treatment with ZIIHERA  by Jazz Pharmaceuticals. Roche's expanded approval aims to enhance personalized treatment options for patients facing challenging cancers.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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This test is now approved to assist in the identification of metastatic breast cancer patients with HER2-ultralow status, making them potentially eligible for treatment with ENHERTU® (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca. Additionally, the test is approved for identifying patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer who may be eligible for treatment with ZIIHERA® (zanidatamab-hrii) by Jazz Pharmaceuticals. Roche's expanded approval aims to enhance personalized treatment options for patients facing challenging cancers.\n      \n\nDisclaimer: 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. Roche Holding AG published the original content used to generate this news brief via PR Newswire (Ref. ID: SF65914) on September 05, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}