Product Analysis and Regulatory Roadmap for Novel Precision Guided Sterile Insect Technology for Spotted Wing Drosophila

Agragene, a San Diego based startup, is pursuing a novel precision guided sterile insect technology for the invasive, agricultural pest species, Drosophila suzukii. There is no regulatory precedent for commercial approval of a similar technology. For many federal and state level regulators, it will be their first time reviewing such technology. The technology will enable Agragene to suppress D. suzukii infestations, which inflict substantial economic losses for the agricultural sector. Suppression would result in increased crop yields and a decreased need for traditional chemical insecticides. The technology involves the use of CRISPR/Cas9 technology to genetically engineer male and female D. suzukii strains to only produce sterile males as progeny. These sterile males will be deployed to sites of D. suzukii infestation, where they will compete with wild type males for mates. This will result in a localized collapse of the reproduction rate due to the overwhelming number of sterile males as the females will be unable to discern between the two types of males. The goal of this project was to clarify the technology, the market, and the regulatory roadmap and options available for Agragene as it pursues commercialization of its product, KNOCK-OUTswd.