2020 AACR: A diagnostic platform for precision cancer therapy enabling composite biomarkers by combining tumor and immune features from an enhanced exome and transcriptome

While the success of immune checkpoint blockade (ICB) has been hugely promising, it’s increasingly apparent that predicting response to immunotherapies requires a more comprehensive approach to tumor immunogenomic profiling. There is a need for the development of more advanced, composite biomarkers that can model the complex systems biology driving response and resistance to modern cancer therapies. Existing targeted diagnostic cancer panels provide limited data which is not sufficient to support the discovery and development of integrative, composite biomarkers; multivariable models that may better predict immuno- and combination therapy response than single analyte alternatives.

To address this need, we developed the ImmunoID NeXT Platform®, an enhanced exome/transcriptome-based platform that can simultaneously profile the tumor and its immune microenvironment from a single FFPE sample. We CLIA-validated this platform, demonstrating high sensitivity and specificity to somatic alterations across ~20,000 genes. As part of our NeXT Dx Test, we provide clinical diagnostic reporting on actionable mutations (SNVs, indels, CNAs, fusions) in 248 cancer-driver genes – genes that benefit from boosted coverage to >1,000X for enhanced performance – as well as the immunotherapy biomarkers, TMB (exome-derived) and MSI.