CE mark
Roche Receives CE Mark for B-Cell Lymphoma Test
The Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail test helps differentiate a B-cell cancer from a normal, reactive immune response.
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.
Agilent CDx Assay IVDR Certified to ID Cancer Patients for Keytruda, Libtayo Treatment
The clearance applies to use of the companion diagnostic to identify patients with multiple cancer types for treatment with Merck's Keytruda and Regeneron's Libtayo.
Geneseeq Nabs CE Marks for Cancer Test Kits
The Toronto-based firm gained marketing clearance in Europe for two kits for profiling solid tumors and one kit for hematological cancer genomic profiling.
Jun 20, 2022
Biocartis Nabs CE Mark for Lung Cancer Test
Jun 17, 2022