2020 AMP: An exome and transcriptome based NeXT Dx™ test enables therapy selection for cancer patients and offers insight into emerging composite biomarkers for immunotherapy

The emergence of immune checkpoint inhibitors has highlighted the potential of immuno-oncology therapeutics to produce unprecedented beneficial responses in cancer patients. However, diagnostic biomarkers that consistently predict patient response to immunotherapies have remained elusive in spite of increased use of these treatments.

There is an unmet need for the development of integrative, composite biomarkers that can model the complex biology driving response and/or resistance to immunotherapy more effectively than existing single-analyte approaches. However, current cancer diagnostic panels, with their focus on a small set of genes, have limited scope and variability in Tumor Mutational Burden (TMB) assessments for certain cancer types, and limited utility to support emerging composite biomarkers that can predict the immune response. To address these limitations, we developed and validated NeXT Dx™, a comprehensive whole-exome and transcriptome based diagnostic test designed to simultaneously characterize tumor and immune microenvironment from a single limited FFPE sample.