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.
The companies plan to develop a broad NGS panel to analyze all known biomarkers for cancer drugs, including tumor mutation burden and microsatellite instability.
The companies are aiming to develop and establish clinical operation for the assays in Japan, where Hitachi said there is growing demand for such tests.
With multiple independent biomarkers, and potential combinations that may require even more subtyping, diagnostics to guide immunotherapy appears to be getting more complicated.
