'Roche wins FDA nod for broader breast cancer tests'

 Roche said on Monday the US Food and Drug Administration has cleared new uses for two of its breast cancer tests, allowing doctors to better identify patients with HER2-positive metastatic breast cancer who may be eligible for ENHERTU. The company said the decision expands the labels for the PATHWAY HER2 (4B5) test and the VENTANA HER2 Dual ISH DNA Probe Cocktail.

With the update, the tests can now detect HER2 expression across its full range, rather than only lower levels. Roche said PATHWAY HER2 (4B5) is now the only approved test that can identify all levels of HER2 expression.

Roche said the expanded approval strengthens its breast cancer diagnostics portfolio and helps clinicians make more precise treatment choices for a disease it described as "a significant challenge," especially in advanced stages.

https://breakingthenews.net/Article/Roche-wins-FDA-nod-for-broader-breast-cancer-tests/65356803