Multiplexed in vitro micronucleus assay for accurate safety screening in early drug development
The potential liability of genetic damage induction is now considered to be an essential part of early safety assessment in the discovery of new drugs. Recent draft guidance proposed by OECD lays the foundation for the advancement of early safety analysis able to predict preclinical toxicity.
Our accelerated throughput micronucleus screening and profiling assay utilizes automated cell image acquisition and analysis technology to obtain objective, consistent and rapid scoring of micronuclei, High Content Cellular Assays.
Predict with Precision: MDS Pharma Services tested multiple options and formats using the high content image acquisition system. The solution we developed provides high level of accuracy with the high throughput and rapid turnaround required for early drug development.
- Nuclei green, Micronuclei white, Mitotic cells red, apoptotic cells blue
- Mitotic and apoptotic cell micronuclei are identified in circles and excluded
- Scored micronuclei are indicated by arrows
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MDS Pharma Services Advantage
- High level of accuracy (sensitivity and specificity)
- Sensitivity assures no genotoxins go undetected
- Specificity reduces additional testing for safe compounds
- Access to scientific expertise and consultation
- Automated, robust, state-of-the-art technology that maximizes data per assay well by measuring micronuclei induction, apoptosis and cell proliferation
- Minimum compound requirements due to 384-well plate format and non-contact acoustic energy based compound addition
- Accelerated throughput screening (200 compounds per week)
- Additional Multiplexed Cytotoxicity testing with multiple cell lines available
Service Features
- Quantitation of micronuclei induction, apoptosis and cell proliferation in one assay well
- Mitotic and apoptotic cells marked for exclusion with Anti-activated Caspase 3 and Anti-phospho-Histone 3 to reduce/eliminate false positive detection
- Solubility by laser based nephelometry defines micronuclei induction at the in vivo relevant concentrations
- 10 pt concentration curve for accurate safety window
- Sensitive and specific Mononucleated micronucleus (MMNA) assay and Cytokinesis blocked micronucleaus (CBMA) assay upon request
- Evaluation of test compounds in the presence/absence of in vitro metabolic activation system (Aroclor1254 induced rat liver S9 fraction)
- Compound testing in pre-validated mammalian system, CHO-K1 cell line
- Reference compound run on each plate
- Minimal compound requirements; 2-7 mg or 300 µL of 50mM in DMSO
- Four week turnaround time
Contact Us
for additional Safety testing information.
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