Research Assays

Learn more about our assays for clinical research

 

Our assays for clinical research can be used as part of the NEOonsite technology platform. They can be performed on a single DNA sample, additional RNA analyses are no longer necessary.

Please contact us if you are interested in using our technology for specific questions as part of your research project.


Assays for clinical research


As part of our NEOonsite platform for research, the NEOplus v2 RUO assay for the assessment of complex biomarker and driver mutations as well as the NEOmyeloid RUO test for the analysis of hematological malignancies are based exclusively on DNA, therefore parallel RNA analyses are not necessary.

Complex biomarkers such as tumor mutational burden (TMB) and microsatellite instability (MSI) are emerging as promising predictive markers, in addition to PD-1/PD-L1 status, for immunotherapy response in cancer patients. Lately, the FDA granted approval to a therapeutic for the treatment of patients with TMB-high solid tumors1.


The NEOplus v2 RUO Hybrid Capture NGS-based assay enables clinical and translational researchers to implement tumor mutational load assessment in their labs. TMB can be defined as the total number of somatic mutations per coding region of the tumor genome. Instead of using whole exome sequencing (WES) for TMB analysis, laboratories can choose smaller, cost-effective, panel-based tests. However, these calculate TMB differently. The challenge of standardization and harmonization of TMB calculation has been assessed by the German Quality Assurance Initiative Pathology (QuIP). Within this study, the NEOplus v2 RUO panel showed excellent correlation to WES data2.


Read this recent publication on implementation of TMB testing in a routine laboratory setting using NEOplus v2 RUO.


Assay overview

  • The assay analyzes up to 340 genes, including immunotherapy-related genes (e.g. ARID1A, POLE, KEAP1 and STK11)3
  • Parallel analysis of TMB, MSI and relevant driver mutations in a single test
  • For TMB assessment NEOplus v2 RUO covers an exonic territory > 1.1 Mb
  • Selection of further analyzed driver gene alterations: point mutations (e.g. KRAS, BRAF, EGFR), InDels (e.g. EGFR, BRCA1/2, MET), gene fusions (e.g. ALK, ROS, FGFR1/2/3, NRG1) and copy number alterations (e.g. MET, ERBB2)


NEOplus v2 RUO: For research use only. Not for use in diagnostic procedures.


1www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors
2 Stenzinger A et al. J Thorac Oncol. 2020 PMID: 32119917
3 Detailed information on the coverage of the respective genes can be found in the instructions for use

 

NEOmyeloid v1 RUO allows for the understanding of myeloid malignancies in clinical research. The assay includes relevant genes associated with acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN) and myelodysplastic syndromes (MDS).

This includes i.a. the following entities:

Point mutations, InDels and gene fusions are detected based on DNA only, additional RNA analyses are no longer necessary


Panel of tested genes:

*Detailed information on the coverage of the respective genes can be found in the instructions for use.

NEOmyeloid v1 RUO: For research use only. Not for use in diagnostic procedures.