PD-L1 Biomarkers
News and reporting on PD-L1 biomarkers.
CAP Releases Testing Guidelines for Immunotherapy Biomarkers in NSCLC
The guidelines focus on how pathologists use approved assays or LDTs, how the results are reported, and which patients should be tested.
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.
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.
Guardant Health to Integrate Lunit's AI PD-L1 Scoring Algorithm Into Tissue Test Offering
The companies have been working together since 2021 following a strategic investment by Guardant in the South Korean AI firm.
Roche Gains IVDR Certificate for Cancer Treatment Companion Dx
TÜV SÜD, a European notified body, claimed it to be the first such certification of its kind.