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

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

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 ...

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

Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...

The PATHWAY HER2 ... neu (4B5) Rabbit Monoclonal Primary Antibody* to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHERTU®.

Basel, 31 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY® anti-HER2/neu (4B5 ...

HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low ... neu (4B5) Rabbit Monoclonal Primary Antibody* to identify patients with HR-positive, HER2-ultralow metastatic ...