In data presented at the ESMO annual meeting, the test showed some ability to distinguish between patients who responded to nivolumab and those who did not.
The test will be based on MRM Proteomics' immunoMALDI approach, which uses antibody enrichment of target proteins followed by analysis via MALDI mass spec.
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.
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.
The company is eyeing a launch for its IVD kits at the beginning of next year, as evidence grows for the integration of TMB analysis into the clinical care of cancer patients.
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.
