As with biocontrol agents, emphasis is placed on safety evaluation at the end of physically confined laboratory testing as a major decision point for whether to enter field testing. These recommendations are organized according to a testing plan that seeks to maximize safety by incrementally increasing the degree of human and environmental exposure to the investigational product. The group developed recommendations for the safe and ethical testing of gene drive mosquitoes, drawing on prior experience with other vector control tools, GM organisms, and biocontrol agents. A multidisciplinary working group considered the implications of low-threshold gene drive systems on the development pathway described in the World Health Organization Guidance Framework for testing genetically modified (GM) mosquitoes, focusing on reduction of malaria transmission by Anopheles gambiae s.l. However, the characteristics of this technology have raised concerns that necessitate careful consideration of the product development pathway. Gene drive systems, such as those based on clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR associated protein, have the potential to spread beneficial traits through interbreeding populations of malaria mosquitoes. Touré, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali, E-mail: drive technology offers the promise for a high-impact, cost-effective, and durable method to control malaria transmission that would make a significant contribution to elimination.
Singh, Centre for the AIDS Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa. Okumu, Ifakara Health Institute, Ifakara, Tanzania, University of Glasgow, Glasgow, Scotland, and University of the Witwatersrand, Johannesburg, South Africa, E-mail: Hector Quemada, Donald Danforth Plant Science Center, Saint Louis, MO, E-mail: Moussa Savadogo, New Partnership for Africa’s Development, Ouagadougou, Burkina Faso, E-mail: Jerome A. Mbogo, Kenya Medical Research Institute, Nairobi, Kenya, E-mail: Fredros O. Lindsay, Durham University, Durham, United Kingdom, E-mail: Charles M. Godfray, Oxford University, Oxford, United Kingdom, E-mail: Brian Greenwood, London School of Hygiene & Tropical Medicine, London, United Kingdom, E-mail: Steve W.
Welkhoff, Institute for Disease Modeling, Bellevue, WA, E-mail: Claudia Emerson, McMaster University, Hamilton, Canada, E-mail: H. Collins, University of Notre Dame, Notre Dame, IN, E-mail: Philip A. Tountas, Foundation for the National Institutes of Health, Bethesda, MD, E-mails: and Frank H. Authors’ addresses: Stephanie James, Michael Gottlieb, and Karen H.
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