Tests

Learn more about our tests for diagnostics and clinical research


Once the NEOonsite platform has been set up in the laboratory, all NEO New Oncology┬┤s molecular tests can be performed in parallel. The assays can be performed on a single DNA sample, additional RNA analyses are no longer necessary.


Molecular diagnostics assays


As part of our CE-marked NEOonsite solution, NEOselect v1 and NEOliquid v1 are suitable for molecular analysis of solid tumors regardless of the indication. Analyses can be performed on routine clinical tissue samples (e.g. FFPE) with NEOselect v1 or blood with NEOliquid v1. All specified gene alterations can be detected from a single tumor DNA sample in a single analysis.

NEOselect v1 is a molecular genetic test that enables the analysis of solid tumors regardless of the indication. The analysis can be carried out on clinical tissue samples such as FFPE samples (fine needle biopsies, punches), cytologies or cryosections.

NEOselect v1 detects tumor relevant point mutations, small insertions and deletions, copy number alterations and gene fusions in oncogenes and tumor suppressors with high sensitivity.

NEOselect v1 panel of tested genes:

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

The products/features (here mentioned) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact NEO New Oncology GmbH for further details.

NEOliquid v1 is a non-invasive blood test for comprehensively analyzing circulating tumor DNA in the blood of cancer patients. Therapy-relevant point mutations, small insertions and deletions and gene fusions can be detected up to an allele frequency of 0.1%. In addition, NEOliquid v1 can sensitively and specifically detect copy number variations of METERBB2 and EGFR in minute amounts of circulating tumor DNA.

NEOliquid v1 allows the parallel analysis of circulating tumor DNA for both the primary tumor and metastases, and can thus also be used for detecting tumor heterogeneity. NEOliquid v1 also enables continuous monitoring of disease progression for therapy control as well as early detection of potential resistance mechanisms.

NEOliquid v1 panel of tested genes

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

The products/features (here mentioned) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact NEO New Oncology GmbH for further details.


Tests for clinical research


The NEOplus v2 RUO assay for the assessment of tumor mutational burden and the NEOmyeloid v1 RUO assay for the analysis of hematological malignancies are based exclusively on DNA, therefore parallel RNA analyses are not necessary.

Recent studies demonstrated that tumor mutational burden (TMB) is an emerging important biomarker in immuno-oncology, e.g. in lung cancer1. To assess the tumor mutational burden, somatic mutations in large exonic protein-coding regions (> 300 genes) must be detected. The NEOplus v2 RUO Hybrid Capture NGS-based assay enables clinical and translational researchers to implement tumor mutational load assessment in their labs. NEOplus v2 RUO allows for the parallel analysis of tumor mutational burden (TMB), microsatellite instability (MSI) and relevant driver mutations (point mutations, InDels, gene fusions, copy number alterations) in a single experiment. In total, NEOplus v2 RUO comprises up to 340 genes, including DNA repair genes (e.g., POLE) and genes involved in the response to new immunotherapies (e.g., B2M, STK11).

 

Assay overview

  • The assay analyzes up to 340 genes*
  • 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, NTRK, FGFR) and copy number alterations (e.g. MET, ERBB2)


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

1 Hellmann MD et al. N Engl J Med. 2018. doi: 10.1056/NEJMoa1801946

*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. Additionally, the Hybrid Capture technology allows for the analysis of atypical gene fusions, such as rare BCR-ABL fusions, that are not detectable in FISH analyses.


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.

 

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