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News and reporting on PD-L1 biomarkers.
The agency approved Agilent/Dako's PD-L1 IHC test for identifying TNBC patients who are most likely to respond to Keytruda and chemo.
The deal provides clinicians with digital access to Flagship Bio's TissueInsight via Inspirata's Dynamyx digital pathology product.
The serum-based proteomic test gauges a pre-treatment immune profile that has shown in retrospective studies to identify patients who are likely to respond well to anti-PD-1 therapy.
The algorithm provides automated assessments of objective and reproducible scanned slide images that can help with diagnosis and targeted treatment options.
The latest approval is immunotherapy Tecentriq's fourth indication in non-small cell lung cancer and fifth indication in lung cancer.
Clinicians can use the PD-L1 IHC 22C3 pharmDx assay to help identify head and neck squamous cell carcinoma patients for treatment with Merck's Keytruda in Europe.
The results are of interest to drugmakers looking for scalable technology solutions for assessment of PD-L1 for predicting immunotherapy response.
Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.
The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.