Daiichi Sankyo
FDA Approves Roche Antibody Test as CDx for Enhertu in HER2-Ultralow Breast Cancer Patients
The tissue-based test is approved to identify a new classification in HER2 expression designated as HER2-ultralow.
Invivoscribe LeukoStrat CDx Gets CE Mark, EMA Approval
The PCR-based test is designed to help in the selection of acute myelogenous leukemia patients eligible for certain treatments.
Invivoscribe Gets FDA Approval for LeukoStrat CDx for Daiichi Sankyo Leukemia Drug
The PCR-based test detects internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
FDA Approves Roche Antibody Test as CDx for Enhertu in HER2-Low Breast Cancer Patients
The test is intended to identify metastatic breast cancer patients with low HER2 expression who could benefit from treatment with Enhertu.
Consortium Aims to Standardize IHC Biomarker Tests for Precision Medicine, Starting With HER2
Premium
The Consortium for Analytic Standardization hopes to bring an archaic technology into the 21st century by producing calibrated standards for the most utilized IHC-based biomarker tests.
Nov 27, 2018
Invivoscribe Submits FLT3 Mutation CDx Assay to FDA
Nov 27, 2018