The EC based its decision on data from the DESTINY-Breast06 trial, which included patients whose tumors had very low levels of HER2 expression.

The approval introduces the first immunohistochemistry (IHC) companion diagnostic test to determine Claudin 18 (CLDN18) ...

When used in conjunction with the PD-L1 IHC 28-8 pharmDx as a companion test, in the European Union: (a) resectable NSCLC patients with PD-L1 expression ≥1% and at high risk of recurrence may be ...

The availability of a simple immunohistochemical (IHC) test for HER2-low status is seen as critical to the successful rollout of Enhertu (trastuzumab deruxtecan) in this category of breast cancer ...

AZ's head of oncology and haematology, Dave Fredrickson, said the approval "highlights the importance of testing metastatic breast cancer tumours for detectable staining with a standard IHC test ...

Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications Agilent Technologies Inc. (NYSE: A) today ...