An NIEHS grantee laboratory is working to validate options for replacing animal use in toxicity testing of drugs and chemicals. The Texas A&M Tissue Chip Validation Center (TEX-VAL) is testing models of human organ systems, called tissue chips, to demonstrate their usefulness for a variety of applications.
"Users of a testing system need to know that it’s technically sound and reproducible, and that it provides meaningful information for decision-making," explained Ivan Rusyn, M.D., Ph.D., director of the TEX-VAL Center. "The validation process addresses both those needs."
"These studies represent the first validation of tissue chip platforms," noted National Toxicology Program (NTP) scientist Warren Casey, Ph.D., who is advising the TEX-VAL Center. Casey, director of the NTP Interagency Center for the Evaluation Alternative of Toxicological Methods (NICEATM), visited Texas A&M University (TAMU) Jan. 23.
Complex and rigorous process
The validation process is complex and rigorous. The TEX-VAL Center is currently testing two tissue chip systems using a set of chemicals with known toxicities. Over the next two years, the center will test a total of 11 chip systems developed by other researchers. Scientists at the center will evaluate the results to determine whether the tissue chips accurately reproduce relevant human body processes. They will also demonstrate consistency by repeating the tests.
Although the laboratory work is important, Rusyn acknowledged that it is not the only factor needed to drive acceptance of tissue chips by regulators. "We need input and discussion with stakeholders to ensure our studies are addressing all the relevant questions about these systems." The TEX-VAL Center will share their work and solicit input from an extensive network of fellow researchers, other academics, regulators, and industry scientists.
The center was established with support from the National Institutes of Health (NIH) Tissue Chip for Drug Screening Program, administered by the National Center for Advancing Translational Sciences and supported by 15 NIH institutes and centers, including NIEHS. Rusyn also directs an NIEHS training grant in regulatory science in environmental health and toxicology.
(Catherine Sprankle is a communications specialist for ILS, the contractor supporting NICEATM.)