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

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 ...

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

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 ...

Background: Variable rates of HER2 protein overexpression and gene amplification have been reported in advanced ovarian cancers (AOC). Trastuzumab, tested only as a single agent, has been shown to ...

Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY ...

As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be ...

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