Introduction:

GenEvolutioN is an expert spin off, dedicated to in vitro genetic toxicology and toxicology expertise using new Human cell models. GenEvolutioN is in line with the evolution of biological and technological progress. The use of stem cells and a whole panel of new techniques is a mark-up. GenEvolutioN is the interaction between the various techniques according to industrial or clinical requirements with an adequate approach to requests in a regulated environment. GenEvolutioN is a genetic toxicology platform with different approaches and also innovative techniques. This project is the result of many years of research and aims to improve the care of patients exposed to genotoxic agents, as well as to further develop personalized medical treatment.

Genetic Toxicology

Telomere – centromere analysis

Innovative technology to analyze chromosome structure.

Recent publication showed implication of shorthenen Telomere size in toxicity after test article exposure. (Radhia publi).

Regarding personnalized medicine, resistance and/or to chimiotherapy treatment is showed to be related to telomere size (publi à ajouter).

You will benefit from a quick and confident technique implemented by Radhia M’Kacher and performed by our skilled team.

Applications

Preclinical and clinical safety evaluation of your test article

Combination of telomere-centromere measurement with chromosome aberration test (OECD 473).

Identification of micronucleus components when combined to in vitro micronucleus assay (OECD 487)

Medical diagnosis to adapt radiotherapy and/or chimiotherapy protocol according to telomere size

Evaluation of potential genotoxic impurities/intermediates, metabolites and batch qualification (ICH M7)

Technical points

GLP and screening in vitro genetic Toxicology Studies

In vitro testing on cell line (TK6) or on human blood from donor or patients

Qualitative and quantitative approach

Test article from chemical synthesis or plant extract

We are also dedicated to perform standard genetic toxicology studies according to OECD guidelines. Our team with 25 years-experience will assist for analysis and interpretation of results.

  • Cytogenetics
    • In vitro micronucleus (OECD 487) on TK6 or human blood

DAPI staining + telomere and centromere staining

Metafer technology for image analysis

    • Chromosome aberration test (OECD 473) on human blood

DAPI staining or mFISH+ telomere and centromere staining

Metafer technology for image analysis

  • Ames Test (OECD 471)

Salmonella typhimurium and/or E. Coli: 5 strains, +/- metabolic activation

  • Mouse lymphoma assay (OECD 490) on L5178Y(TK locus) cell line

In vitro Toxicology

We offer services to evaluate your ingredients, cosmetic substances, plant extracts, chemicals or drugs regarding phototoxicity, corrosion and irritation potential according to regulatories ie SCCS 9th revision, REACH, OECD.

GLP and screening in vitro Toxicology Studies

In vitro Skin Irritation assay (OECD 439)

Reconstructed Human Epidermis Test Method

Classification irritant (UN GHS category 2) / non irritant (UN GHS no category)

In vitro Skin Corrosion assay (OECD 431)

Reconstructed Human Epidermis model

Classification corrosive (UN GHS subcategory 1A/ sub categories 1B-1C/ non corrosive (UN GHS no category)

In vitro 3T3 NRU phototoxicity test (OCDE 432)

Reactive Oxygen Species (ROS) assay (JaCVAM protocol, Sept 20th 2013)

The sensitive assessments will be performed using the SENS-IS technology developed by the company IMMUNOSEARCH, allowing evaluation under GLP regulatory procedures for cosmetic and chemicals compounds. In vitro Human skin sensitization evaluation using SENS-IS method, replace LLNA (in vivo method).

Others tests

Embryotoxicity evaluation

Embryonic Stem cell Test (EST)

Evaluation of the developmental toxicity potential of compounds during in vitro cell differenciation into cardiomyocyte-cell type. This assay can be a great solution scientifically validated by ESAC as a screening test

and in accordance with the EU Cosmetic regulation (EC N°1223/2009) where in vivo studies for reproductive purpose have been prohibited since 2013.

Mouse D3 stem cell/3T3 fibroblasts

ECVAM protocol

Classification non embryotoxic, weak/moderate or strong embryotoxic

Cytotoxicity test

3T3 fibroblasts

Neutral red Uptake

Parameter: determination of IC50

Stem cell characterization

GenEvolutioN’s innovation is part of our “break strategy” using integrated cytogenomics techniques and cellular engineering developed by our INGESTEM‘s partnership (www.ingestem.fr ).

Genomic instability (to qualify stem cell batches) :

G-Banding, M-FISH (5 colors), telomere centromere staining

New in vitro models:

Propose new in vitro pathologic models and healthy model with stem cells (Blood cells, cardiac cells etc ) with our partners INGESTEM, AXIOGENESIS ….

Scientific advisor and consulting

Based on sharing of many years of knowledge in biotechnology fields with a strong professional network we are able to fix a strategic plan for a tier.

Our expertise and well-adapted strategies is provided for the assessment of the use of plants in medical and cosmetic treatment, especially as they are increasingly and widely developed by pharmaceutical and cosmetic labs.

Support in your strategy development for chemical, biological or plant extracted agent concerning your safety evaluation.

Contribution of our expertise in vitro toxicology for the analysis of our results obtained in preclinical studies. Studies Monitoring.