Merck
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.
The firm is expanding its lab capabilities and leveraging its test development reputation to form partnerships early in the drug development process.
Agilent CDx Assay IVDR Certified to ID Cancer Patients for Keytruda, Libtayo Treatment
The clearance applies to use of the companion diagnostic to identify patients with multiple cancer types for treatment with Merck's Keytruda and Regeneron's Libtayo.
Industry Groups Form European Coalition to Push for Better Comprehensive Genomic Profiling Access
A coalition of a trade group and drugmakers and diagnostics firms aims to share best practices and recommendations for better test reimbursement and uptake.
Agendia Building Validation Data on ImPrint for Guiding Neoadjuvant Immunotherapy in Breast Cancer
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The firm envisions marketing the 53-gene signature with its existing MammaPrint and BluePrint tests as a comprehensive platform for breast cancer treatment selection.