The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.
The diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
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.