June 7, 2018 — The American Journal of Tropical Medicine and Hygiene (AJTMH) has published an article outlining recommendations for the safe and ethical testing of gene drive technology on mosquitoes to reduce the burden of malaria transmission in Africa. An international, multidisciplinary working group comprised of experts in many aspects of mosquito research, assembled by the Foundation for the National Institutes of Health (FNIH), wrote the article titled, “Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa: Recommendations of a Scientific Working Group.” The recommendations propose a pathway for the responsible development of gene drive products, from initial discovery research to implementation, to inform researchers, funders, regulators and policy makers.

Malaria continues to be a public health priority, with 216 million cases and 445,000 deaths attributed to the disease in 2016, according to the World Health Organization (WHO). Sub-Saharan Africa is disproportionately burdened by the disease as it is the location of the deadliest malaria parasites and efficient mosquito vectors. Gene drive systems, such as CRISPR/Cas9, may hold the promise of a high-impact, cost-effective and durable method to control malaria by spreading genetic traits that would reduce parasite transmission through interbreeding populations of mosquito vectors, such as members of the Anopheles gambiae species complex in Africa. However, as an emerging technology still in its early stages, gene drive requires careful consideration and assessment before products using the technique can be tested and deployed.

The recommendations build upon the product development pathway described in 2014 by the WHO in The Guidance Framework for testing genetically modified mosquitoes, as well as a 2016 gene drive report from the National Academies of Science, Engineering and Medicine. The AJTMH-published recommendations outline a pathway that evaluates the safety and efficacy of potential gene drive products through multiple phases, with each stage increasing the degree of human and environmental exposure, drawing on existing regulatory precedents. For example, scientists will conduct thorough safety assessment within a confined laboratory setting before deciding to proceed with field testing. The authors recognize that gene drive evaluation will require significant advanced preparation among researchers, funders, governing agencies and local communities, and will be subject to stringent regulatory and ethical approvals, as well as social acceptance.

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