Zefit's zebrafish toxicity platform zDART accepted into FDA ISTAND program

South Korea's Zefit said the FDA accepted its letter of intent for zDART, a zebrafish embryo-based developmental toxicity platform, into the ISTAND qualification program. It is the first zebrafish-based assay to enter ISTAND, with the goal of replacing rabbit testing.

• FDA accepted the zDART LOI in a decision letter dated Sept. 22
• First zebrafish-based assay to enter the ISTAND process
• zDART predicts rabbit test results alongside rat data
• Initial use targets cancer and severe-disease drugs