Analytical process for genotoxicity assessment
OwnerMichael Rothe, Axel Schambach +3inventors
InventorsMichael Rothe, Axel Schambach, Christopher Baum, Ute Modlich, Adrian Schwarzer
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Abstract
The present invention relates to an analytical process for the assessment of the genotoxic potential, also termed mutagenic or transforming activity, of an agent in respect to hematopoietic cells. The agent can be selected from natural and synthetic chemical compounds, and preferably from heterologous expression cassettes, e.g. contained in non-natural viral particles or non-natural viral nucleic acid constructs, e.g. nucleic acid constructs containing a viral element.
Claims15
Process for analysis of the genotoxic activity of an agent for primary hematopoietic cells, the process comprising the steps of adding the agent to the primary hematopoietic cells in culture under cell culture conditions, cultivating the cells for a pre-determined duration to produce cultivated cells, characterized by the step of isolating total RNA from the cultivated cells, determining the concentration of at least one, preferably all, of the RNAs selected from the group comprising
- AFAP1L1,
- ALS2CL,
- ARX,
- BEX6,
- CCDC102A,
- DCTD,
- EHD3,
- GM805,
- GUCY1A3,
- MEX3A,
- MYCT1,
- NAIP1,
- NOLC1,
- PA2G4,
- PDGFRB,
- PHLDA2,
- SLA2,
- SLC12A2,
- SOX14,
- SOX4,
- SPNS2,
- TBXA2R,
- TC1649157,
- TIE1,
- TlVfEM176A,
- TlVfEM176B,
- TOX, and
- ZFPM1,
- and relating the concentrations of the mRNAs to the concentrations of mRNAs determined for cells cultivated under the same cell culture conditions for the same duration in the absence of the agent.
Dependencies are inferred from the claim text.