Assays

Hybrid-capture reagents for various questions in routine 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


The CE-labeled NEOselect and NEOliquid assays are suitable for analysis of solid tumors regardless of the indication. Analyses can be performed on routine clinical tissue samples (e.g. FFPE) or blood. All specified gene alterations can be detected from a single DNA sample in a single experiment.

NEOselect

NEOselect 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 detects therapy-relevant point mutations, small insertions and deletions, copy number alterations and translocations in oncogenes and tumor suppressors with high sensitivity. In addition, NEOselect enables detection of microsatellite instability.

NEOselect panel of tested genes:

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

NEOliquid 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 can sensitively and specifically detect copy number variations of METERBB2 and EGFR in minute amounts of circulating tumor DNA.

NEOliquid 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 also enables continuous monitoring of disease progression for therapy control as well as early detection of potential resistance mechanisms.

NEOliquid panel of tested genes

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.



Assays for clinical research


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

NEOplus RUO

Recent studies demonstrated that tumor mutational burden (TMB) is an emerging important biomarker for predicting the response to immunotherapy, 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 RUO hybrid capture NGS-based assay enables clinical and translational researchers to implement tumor mutational load assessment in their labs. NEOplus RUO allows for the parallel analysis of tumor mutational burden (TMB), MSI and relevant driver mutations (point mutations, InDels, gene fusions, copy number alterations) in a single experiment. In total, NEOplus comprises more than 340 genes, including DNA repair genes (e.g., POLE) and predictors of response to immunotherapies (e.g., B2M, STK11).

 

Assay overview

  • The assay analyzes more than 340 genes
  • For TMB assessment NEOplus 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

 

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NEOmyeloid RUO

NEOmyeloid RUO allows for the understanding of myeloid malignancies in clinical research. The assay includes relevant genes that might influence diagnosis, prognosis and/or therapeutic management in acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN) and myelodysplastic syndromes (MDS). This includes i.a. 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. The detection of chromosomal aberrations and copy number alterations will be available soon.*


Panel of tested genes

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

*The product is still under development and not commercially available yet. Its future availability cannot be ensured.

 

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Address

NEO New Oncology GmbH
Gottfried-Hagen-Str. 20
51105 Cologne
Germany

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