The diagnostic can now be used to identify a wider range of patients with stage III or metastatic NSCLC who may benefit from first-line treatment with Keytruda.
The test will be used to identify men with metastatic, castrate-resistant prostate cancer and germline BRCA mutations who are enrolled in a study for olaparib.
The test uses multiplex PCR fragment analysis with Promega-designed five-mononucleotide repeat markers to detect the MSI-high phenotype within tumor tissues.
PGDx and KingMed plan to provide tumor mutational burden testing to pharmaceutical companies for clinical trials in China and Hong Kong.
The immunohistochemistry-based CDx will operate on the Roche BenchMark ULTRA instrument.
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify cervical cancer patients who may benefit from the anti-PD1 immunotherapy.
The companies plan to develop a pan-cancer CDx to measure microsatellite instability and CDx tests for tumor mutational burden and other novel biomarkers of response.
Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.
With multiple independent biomarkers, and potential combinations that may require even more subtyping, diagnostics to guide immunotherapy appears to be getting more complicated.