FDA and NCATS grants to develop tissue chips for botulinum toxin testing
Tissue chips have emerged as an in vitro alternative to animal use with the potential to be more predictive of human response in the safety and efficacy assessment of leading therapeutics. In 2022 and 2023, NCATS and FDA offered small business innovation research and business technology transfer grants for the development of neuromuscular junction tissue chips to replace the mouse lethality bioassay as a potency assay for botulinum toxin. A main objective for this funding opportunity was to position these tissue chips as an alternative test method as a standalone replacement for mouse lethality bioassays.