At OncoDNA we have developed a 5 parameters immunogram, combining the testing of:
- The level of expression of PD-L1
- The level of expression of CD8 in Lymphocytes
- The tumor mutational burden (TMB)
- The microsatellite instability (MSI)
- The presence of mutations associated with resistance or sensitivity to ICP inhibitors.
5 parameters immunogram
Expression of PD-L1
This is the first FDA approved biomarker. If several antibodies exist to detect PD-L1 expression, only PD-L1 IHC 22C3 pharmDx (Dako) is approved as a companion diagnostic for pembrolizumab. Dako’s PD-L1 IHC 28-8 pharmDx is approved as a complementary diagnostic for nivolumab. These two antibodies and others are available at OncoDNA.
CD8 T-cell infiltrate as detected by IHC
The presence of CD8+ lymphocytes has been associated with better clinical outcomes for patients treated with ICP inhibitors.
The tumor mutational burden (TMB)
TMB is a measurement of the mutations carried by tumor cells (number of mutation by units of coding area) and it correlates with higher level of neoantigens. High TMB has been associated to better response and increased survival rate for patients treated with ICP inhibitors.
The microsatellite instability (MSI)
MSI, a type of genomic instability, is characterized by gains or losses of nucleotides from microsatellite tracts. It results from impaired DNA mismatch repair (MMR) and MSI-H(igh) status has been associated with high response rates and survival benefit for patients treated with checkpoint inhibitors.
Mutations associated with sensitivity or resistance to ICP inhibitors
Mutations associated with sensitivity (e.g. POLE inactivating mutations) or resistance (e.g. STK11 inactivating mutations) to ICP inhibitors. We can test this continuously growing number of variants associated with an impact on immunotherapy.
The Most Comprehensive Genomic and protein based solution
This immunogram is the most comprehensive genomic and protein based solution on the market. But it can of course be tailored according to our biopharma customers’ specific needs, including any other molecular characterization parameters such as IHC tested CD3 or PD-L2 expression, RNA-Seq or Whole Exome Sequencing.
In the case of combination studies, in addition to the Immunogram, we can also provide comprehensive molecular characterization of patients using DNA/NGS (for targeted therapies) or IHCs (for chemotherapies) characterization.