<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>

罗氏(ADR)

<p>罗氏获得了美国 FDA 对其 PATHWAY HER2 (4B5) 检测的扩展批准，现在该检测适用于所有乳腺癌患者，无论 HER2 表达水平如何。此前，该检测仅被批准用于低或超低 HER2 表达的患者。该检测可以识别出符合使用 Daiichi Sankyo 和阿斯利康的抗体治疗 Enhertu 的患者</p>

罗氏获得 FDA 对乳腺癌检测的扩展批准