Companion Diagnostics
News on companion diagnostics and drug/test co-development.
Agilent Technologies Gains Expanded IVDR Certification for PD-L1 CDx
The test has been certified for use in the EU to help guide the treatment of early-stage non-small cell lung cancer and previously untreated advanced melanoma.
Foundation Medicine, Sumitomo Pharma to Develop CDx for Acute Leukemia Treatment
The companies will use the FoundationOne Heme platform to identify patients with acute leukemia who have a KMT2A rearrangement or NPM1 mutations.
In Brief This Week: FDA, Tempus AI, Myriad Genetics, More
News items for the week of Feb.3, 2025.
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.
Foundation Medicine Assay Nabs FDA Approval as CDx for Ojemda in Pediatric Patients
The FoundationOne test can be used to identify patients with relapsed or refractory BRAF-altered pediatric low-grade glioma who may be eligible for therapeutic options.