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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 company's PD-L1 IHC 28-8 pharmDx diagnostic can now be used in cases of urothelial carcinoma and squamous cell carcinoma of the head and neck.
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.
The recent failure of Bristol-Myers Squibb's lung cancer immunotherapy to meet its primary endpoint demonstrates the challenge of working with imperfect biomarkers.