Companion Diagnostics
News on companion diagnostics and drug/test co-development.
Amgen's Lumakras, Vectibix Net FDA Approval in KRAS G12C-Mutant Colorectal Cancer
The FDA also approved Qiagen's Therascreen KRAS RGQ PCR kit as a companion diagnostic to identify KRAS G12C-mutant patients.
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.
Agilent Technologies Nabs IVDR Certification for PD-L1 CDx
The PD-L1 IHC 28-8 PharmDx test is used to provide information on PD-L1 expression as a biomarker for patient response to therapies containing anti-PD-1 antibodies.
HER2 Biomarker Evolving as Enhertu Shows Activity in Breast Cancers With Ultralow Expression
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The new HER2-low category is exposing the limitations of IHC testing, challenging pathologists, and has oncologists revisiting patients' old test results.
The firm presented early data for a blood-based approach to screen prostate cancer patients for PSMA, which it believes has advantages over PET imaging.