DURHAM, N.C. (PRWEB) MARCH 20, 2023
ScitoVation today announced the availability of next generation, non-animal genotoxicity assays for lead candidate selection. These assessments will provide clients genotoxicity assessments during drug discovery or early lead compound development that are highly predictive of outcomes from the regulatory genetic toxicology test battery.
Knowledge regarding the potential of pharmaceuticals, food additives or chemicals to damage the human genome and cause mutations remains critical to public health. Mutations are key events in the induction of cancer, birth defects, and neurological disease. The regulatory genetic toxicology test battery required by the US Food and Drug Administration (FDA) for Investigational New Drug applications to initiate clinical trials, and by the US Environmental Agency (EPA) for registration of pesticides, includes approved in vitro tests for assessing genotoxicity and mutagenicity. A positive response in this regulatory test battery can eliminate drug candidates from further development or require further in vivo testing to demonstrate safety, which add significant time to development and can be costly.
ScitoVation’s New Genotoxicity Program includes:
- Computational Tools for Testing Mutagenicity (AMES Test): Quantitative structural-activity relationship (QSAR) tools that are highly predictive of bacterial mutagenicity test (Ames Test). The use of QSAR offers an efficient means from both cost and timing perspective to triage candidates and focus additional in vitro testing on more promising candidates.
- Micronucleus Assay: For lead candidates, the OECD compliant in vitro micronucleus assay using human TK6 or HepaRG™ cells.
- Toxicogenomic Genotoxicity Biomarker TgX-DDI: provides a point of departure that can be used to translate the in vitro results to human equivalent dose. This biomarker is currently undergoing FDA validation as biomarker predictive of mammalian genotoxicity.
Current genetic toxicology assessments are increasingly challenging due to backlogs and outdated technologies. ScitoVation’s Chief Scientific Officer and program creator, Leslie Recio, PhD, explains, “Our genotox program is aimed at identifying potential genotoxicity hazards early, saving time and resources by reducing the potential for positive outcomes in the regulatory genetic toxicology test battery that can stop further development.”
Dr. Jean Orelien, ScitoVation CEO, is pleased to offer this program to clients: “I’m pleased that in addition to providing the regulatory accepted micronucleus assay, consistent with our commitment to innovate for our clients, we will provide additional value by helping our clients assess genotoxicity using promising novel methods such as toxicogenomics.”
ScitoVation is focused on modernizing safety assessment for early-stage development using human biological models integrated with mode-of-action genomic and computational toxicology tools as New Approach Methodologies (NAMs) for human risk assessments.
Ordering for the micronucleus assay will open on April 3rd. Please visit scitovation.com/services/cell-based-assays/genotox/ for more information.