Roche Gets Expanded FDA Approval for Breast-Cancer Test

Dow Jones12-16

By Elias Schisgall

Roche received expanded approval from the Food and Drug Administration for a test to diagnose breast cancer.

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.

The company said its test is now the only diagnostic approved for patients with all levels of HER2 expression.

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.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

December 15, 2025 15:18 ET (20:18 GMT)

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