Companion Diagnostics
News on companion diagnostics and drug/test co-development.
FoundationOne Test Nabs FDA Approval as CDx for AstraZeneca Breast Cancer Combination Therapy
The drug combination has been approved to treat patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with certain alterations.
Foundation Medicine, Pierre Fabre Laboratories to Collaborate on CDx for Lung Cancer
The companies will seek approval for Foundation Medicine's assays identifying patients for treatment with Pierre Fabre's BRAF/MEK inhibitor combination regimen.
Agilent Gets FDA Approval of Expanded Use of CDx Assay for Keytruda
The firm said it secured agency approval for its PD-L1 IHC 22C3 PharmDx test to guide treatment of patients with gastric or GEJ adenocarcinoma.
ARUP Laboratories Gains IVDR-CE Mark for Hemophilia Gene Therapy CDx
The Salt Lake City-based firm's test is used to identify hemophilia A patients eligible for treatment with BioMarin's Roctavian gene therapy.
The firm is expanding its lab capabilities and leveraging its test development reputation to form partnerships early in the drug development process.