TABLE III.

Session 3 SWOT Analyses: New Technologies and Approaches

Test/system	Strengths	Weaknesses	Opportunities	Threats
Imaging for safety assessment	Longitudinal study design and minimal invasiveness. Acceptance of imaging by the medical community enhances its utility as a translatable pre-clinical biomarker. Can be highly quantitative. Minimally to noninvasive. The test animal or human subject can serve as its own control.	No standardized approach. Deficits in quantization. A powerful technology looking for an application for genetic toxicology and carcinogenesis.	Broad applications due to recent advances in resolution and standardization of approaches. Identification of early toxic or precarcinogenic changes in situ.	Expensive technology. Not universally available.
Tox21 strategy for detecting genotoxicants	Capability to test thousands of chemicals in human, or other species, cells. Very small amounts of compound needed for screening. Rapid generation of test data. Eliminates or greatly reduces use of animals. Large number of cell lines can be used. Provides MOA information.	High throughput screens currently lack means to provide bioactivation. Limited number of suitable genotoxicity assays currently available. Tested compounds limited to those that are DMSO- soluble, nonvolatile, stable in solution for a period of time, etc. No or limited, evaluation of metabolites. Expensive. Data processing complexity heavily software dependent.	Ability to develop approaches to assess differential susceptibility on a wide-spread scale. Ability to identify susceptible subpopulations using genomic assays. Ability to develop comprehensive profiles of chemical activity. Ability to develop SAR and chemical clustering models based on chemical activity. Potential to reduce the number of animals needed for toxicity testing.	Challenges in anchoring chemical profiles for genotoxicity-associated activity generated with these technologies to results from traditional tests for genotoxicity with sufficient accuracy to be acceptable to regulatory agencies. Biological relevance and reliability of the selected assays for risk assessment. Reproducibility across cell lines.
Genomic Signatures of Genotoxicity	Query large swaths of biological space in one assay. Provides pathway/mechanistic information.	In vivo genomics dependent on animals. Ability to interpret complex data. Variability (time-dependent, platforms, dose). Lack of mechanistic anchoring (need more correlative data).	High dimensionality allows for querying of large amount of biological space including genotoxicity and beyond (i.e., one assay to query all). Potential to rapidly identify a no-effect dose. Potential to reduce the numbers of animals needed to characterize toxicities.	Metrics (i.e., genes and path- ways) are different from traditional endpoints. If it is not possible to change metrics (i.e. pathology to pathways), it will significantly hinder development in the regulatory arena. Reproducibility of results across testing platforms and between laboratories.