Does the Bacterial Reverse Mutagenicity Assay work for Nanotherapeutics?

J.F. Alexander, D. Aguirre, B. Godin, J.F. Alexander
The Methodist Hospital Research Institute, US

Keywords: nano, nanomedicine, nanotherapeutic, nanovector, mutagenicity, genotoxicity, ames, mutation assay, doxorubicin


The application of nanotechnology in the world of medicine has created diverse nanotherapeutics with the hope to efficiently treat several diseases, including cardiovascular diseases and cancer. The United States Food and Drug Administration requires many test batteries to effectively screen therapeutics for their toxicity. The first test in line for determining the genotoxicity of the materials is the Ames Mutagenicity Assay or the Bacterial Reverse Mutation Assay, developed by Bruce Ames and colleagues in early 1970s. However, the validity of this test for nanotherapeutics has not been evaluated yet. The objective of our study was to find if the assay could apply to analyzing the mutagenicity of nanotherapeutics – nanoparticles loaded with therapeutic drug, and confirm if the Ames test should be modified for evaluation of the mutagenic potential of a drug encapsulated in nanocarrier.