High-throughput approaches for genotoxicity testing in drug development: recent advances

Abstract

New molecules targeted at enhancing quality of life undergo various tests to evalu- ate their efficacy and biosafety before approval. However, there is an urgent need to develop a standardized set of tests and regulatory standards to ensure all molecules comply with biosafety standards at all stages. Though there is a battery of tests used to assess the toxicity of various compounds under study, the inability of these tests to yield a consensus serves as a major draw- back. In addition, the time-consuming and labor-intensive nature of these tests does not aid in accelerating the process of screening and identification of molecules with high efficacy and low toxicity. Modernization and standardization of a current battery of tests to a common end point in combination with identification of novel molecular markers for assessing genotoxicity seems to be the way forward. The establishment of high-throughput screening to assess vari- ous biomarker parameters, such as DNA damage to evaluate genotoxicity, offers rapid, cost- effective, and non-labor-intensive screening, a potential solution to the challenge mentioned. We here review the tests that are currently in use for assessing the genotoxicity potential of various compounds. Furthermore, the review also offers an overview of recent advancements in conventional techniques and use of various molecular markers in an effort to establish high-