<div id="readability-page-1"><div><p>By Elias Schisgall</p><p>   Roche received expanded approval from the Food and Drug Administration for a test to diagnose breast cancer. </p><p>    The pharmaceutical company said Monday that the FDA approved the PATHWAY HER2 (4B5) test for all patients. It had previously been approved only for patients with low or ultralow HER2 expression. </p><p>    The company said its test is now the only diagnostic approved for patients with all levels of HER2 expression. </p><p>    The test is used to identify patients which could be eligible for Enhertu, an antibody treatment currently being developed and commercialized by Daiichi Sankyo and AstraZeneca. </p><p>   Write to Elias Schisgall at elias.schisgall@wsj.com </p><p>   (END) Dow Jones Newswires</p><p>12-15-25 1533ET</p></div></div>

羅氏(ADR)

<p>羅氏獲得了美國 FDA 對其 PATHWAY HER2 (4B5) 檢測的擴展批准，現在該檢測適用於所有乳腺癌患者，無論 HER2 表達水平如何。此前，該檢測僅被批准用於低或超低 HER2 表達的患者。該檢測可以識別出符合使用 Daiichi Sankyo 和阿斯利康的抗體治療 Enhertu 的患者</p>

羅氏獲得 FDA 對乳腺癌檢測的擴展批准