<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>

RHHBY

<p>Roche has received expanded FDA approval for its PATHWAY HER2 (4B5) test, now approved for all breast cancer patients regardless of HER2 expression levels. Previously, it was only approved for low or ultralow HER2 expression. This test identifies patients eligible for Enhertu, an antibody treatment by Daiichi Sankyo and AstraZeneca.</p>

Roche Gets Expanded FDA Approval for Breast-Cancer Test