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
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.
Thermo Fisher Scientific, Daiichi Sankyo Partner to Develop Non-Small Cell Lung Cancer CDx
The assay will identify patients with mutations in HER2 who may be eligible for treatment with a HER2-directed antibody-drug-conjugate developed by Daiichi.
Japanese Regulators Approve Invivoscribe Assay as CDx for Daiichi Sankyo AML Drug
The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.
Invivoscribe Submits FLT3 Mutation CDx Assay to FDA
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.