With ImmunoID NeXT, oncology translational and clinical researchers can, for the first time, comprehensively analyze both a tumor and its microenvironment from a single tumor sample. It enables customers to maximize the data generated from each sample while also decreasing the complexity of data interpretation by eliminating the need to integrate multiple assay technologies and reporting formats from several sources. Specifically built for immuno-oncology and all precision oncology applications, the ImmunoID NeXT Platform can be used to investigate key areas of tumor biology; from elucidating mechanisms of tumor escape and detecting neoantigens, to identifying novel gene expression signatures and characterizing the immune repertoire. With these extensive capabilities, ImmunoID NeXT effectively consolidates multiple biomarker assays into one.

The unique, innovative design of the assay and analytical algorithms enables the delivery of critical tumor and microenvironment-related information such as:

• T-cell receptor (TCR) alpha and beta repertoire composition
• Neoantigen detection and neoantigen load
• Human leukocyte antigens (HLA) analytics
  • HLA Class I and II typing
  • HLA LOH and somatic mutations
• Tumor mutational burden (TMB)
• Microsatellite instability (MSI) characterization
• Tumor escape and resistance mechanisms
• Oncoviral detection
• Somatic single nucleotide variation (SNV), insertion/deletion (indel), gene fusion, and copy number alteration (CNV) detection
• Germline variant detection

ImmunoID NeXT analytics leverage the accurate, raw data to evaluate the status of the most relevant oncology biomarkers, as have been identified and investigated in the literature.

RepertoireID enables the analysis of the TCRα and TCRβ repertoire clonotypes in patients’ tumor FFPE (as well as fresh frozen) samples. The ultra-deep, TCR-specific RNA sequencing data derived from the NeXT assay is processed by our TCR Analytics Engine, and a report is generated providing key metrics such as expressed clonality; CDR3 nucleotide and amino acid sequences; clonotype quantitation, distribution, and frequency; V, D, and J gene segments usage and overlap; and CDR3 nucleotide sequence length. These deliverables enable researchers to investigate the TCR repertoire’s potential as a predictive biomarker of response to immunotherapies and combination therapies.

ImmunoID NeXT is the first commercial platform that enables the comprehensive characterization of the immune repertoire using data derived from an augmented, exome-scale platform, designed specifically to explore multidimensional oncology biomarkers.

ImmunogenomicsID provides an overview of TME-related biomarkers and critical genes that are involved in – or highly impact – key oncology functional groups including antigen presenting machinery (APM), HLA (including genotyping for HLA Class I and II loci as well as Class I LOH and somatic mutation detection, DNA repair and replication, immune checkpoint modulation, tumor associated antigens (TAAs), adaptive and innate immune response, cytokines and chemokines, and cytotoxicity, while also providing a readout on the MSI status of the tumor and the presence (or absence) of seven of the most common oncogenic viruses.

Deep and uniform coverage (of both DNA and RNA) is critical for both comprehensive neoantigen identification and the accurate assessment of neoantigen load. ImmunoID NeXT ensures highly-sensitive variant detection via both the depth of sequencing (~300X mean coverage) and the augmented coverage of difficult-to-sequence regions across the entire >20,000 gene footprint. Combined, these features reduce the chances of neoantigen-producing variants (SNVs, indels, and fusions) going undetected.

NeoantigenID utilizes the tumor and matched normal ImmunoID NeXT configuration to accurately differentiate between somatic and germline mutations and to generate analytics for the identification of potentially immunogenic neoantigens, incorporating information such as HLA typing, MHC-binding prediction (for Class I and Class II), similarity-to-self, similarity-to-known antigens, and immunogenicity.

In addition to the identification of putative neoantigens for personalized therapeutic development, NeoantigenID also provides an evaluation of the mutational landscape of the tumor, delivering both the neoantigen load and TMB for biomarker discovery applications.