A scalable solution for tumor mutational burden from formalinfixed, paraffin-embedded samples using the Oncomine Tumor Mutation Load Assay

Therapeutic antibodies targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and programmed cell death protein 1 (PD-1) immune checkpoints result in increased activation of the immune response and have shown remarkable clinical benefit in patients with diverse cancer types (1-7). However, although these approaches have transformed treatment strategies in certain cancer types, most cancer patients are not yet effectively treated with these approaches and a minority experience serious adverse events due to sustained immune activation (8,9)