OncoGxOne™ includes fragment analysis of five well-validated satellite regions recognized by national guidelines. MSI is the result of a deficient mismatch repair system. Tumors with MSI-High tend to have an increased neoantigen burden, an indication that the patient may benefit from cancer immunotherapy. If two of more sites are detected as unstable the sample will be classified as MSI-High.
TMB is a quantitative and genomic-based biomarker for cancer immunotherapy selection. OncoGxOne™ measures the total number of somatic mutations per mega base (MB), classifying TMB as:
TMB-High with mutations > 10 per MB
TMB-Low with mutations 10 per MB
Tumors with TMB-High tend to have an increased neoantigen burden, an indication that the patient may benefit from cancer immunotherapy.
Not all tumors determined to be MSI-High or TMB-High respond to tumor checkpoint inhibitors. It has been hypothesized that tumors with high HLA heterozygosity will have a strong antitumor immune response. OncoGxOne™ genotypes 14 HLA alleles to determine both homozygosity and heterozygosity which can be used to further stratify potential responders to cancer immunotherapy.