The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...

Breast Tumor Section showing nonamplified HER-2/neu (<4 signals/nucleus). Cells are stained with DAPI. Probe is detected with flurorescein. There is perhaps nothing more disturbing to a woman than a ...

Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...

The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer are eligible for T-DXd treatment.

The FDA has specified use of the Ventana Pathway anti-HER2/neu (4B5) antibody assay. Additionally, the American Society for Clinical Pathology has guidelines for testing for HER2. Support for the ...

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The tissue-based test is approved to identify a new classification in HER2 expression designated as HER2-ultralow.