The deal will focus on Biocartis' Idylla MSI test, which provides information on a tumor's microsatellite instability status of a tumor from a single FFPE slice.
The trial will test two Bristol-Myers Squibb cancer drugs in patients with metastatic or unresectable tumors harboring mutations in the genes POLE and POLD1.
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.
With multiple independent biomarkers, and potential combinations that may require even more subtyping, diagnostics to guide immunotherapy appears to be getting more complicated.
BMS amended an ongoing Phase III study of Opdivo and Yervoy to evaluate outcomes based on tumor mutational burden using Foundation Medicine's NGS companion diagnostic.
The partners will develop biomarkers and assays to evaluate non-alcoholic steatohepatitis, a disease characterized by liver scarring due to inflammation.
At the Personalized Medicine World Conference, stakeholders and the former FDA commissioner discussed how regulation can advance personalized medicine amid political uncertainty.
