IHC
FDA Approves Roche CDx Test for Use With Jazz Pharmaceuticals Drug in Biliary Tract Cancer
The approval is for a new indication for Roche's existing Pathway HER2 (4B5) test and is intended to identify patients with HER2-positive biliary tract cancer.
Roche IHC Assay Nabs CE Mark as Companion Diagnostic for Abbvie's Elahere in Ovarian Cancer
The immunohistochemistry test detects the folate receptor 1 protein, which is over-expressed in most ovarian cancers.
Roche CDx Test Receives CE Marking for Use in Gastric Cancer Patients
The IHC companion diagnostic test determines CLDN18 protein expression and may help identify patients who are eligible for treatment with Vyloy.
Roche PD-L1 Assay Nabs Expanded CE Mark as CDx for Libtayo, Chemotherapy Combo
The Ventana assay previously received CE marking for identifying patients with lung cancer who may benefit from treatment with Libtayo.
Roche CDx for Enhertu in Breast Cancer Nabs CE Mark
The test is intended to identify metastatic breast cancer patients with low HER2 expression who may be eligible for Enhertu as a targeted treatment.
Nov 2, 2023
Aug 8, 2022