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

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for ...

FDA approval of PATHWAY HER2 (4B5) test expands diagnostic capabilities for HER2-ultralow metastatic breast cancer, enabling targeted treatment with trastuzumab deruxtecan. HER2-ultralow ...

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...

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

Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...

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

The Swiss pharmaceutical company said the FDA backed a label expansion for the Pathway HER2 (4B5) test to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who could be ...

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