---

Guidance framework for testing of genetically modified mosquitoes, second edition

17049
WHO,  WHO-TDR,  2021-05-19 10:41:03. Link
For more than 2 decades, scientists have been working to harness the promise of molecular biology to develop genetically modified mosquitoes (GMMs) for use as public health tools to prevent the transmission of vector-borne diseases. Responding to a need for additional standards and guidance, the WHO Special Programme for Research and Training in Tropical Diseases (WHO-TDR) and the Foundation for the National Institutes of Health (FNIH) published in 2014 the first WHO Guidance framework for testing genetically modified mosquitoes. This revised version takes into account the technical progress made and lessons learned in this rapidly advancing field of research. Like the original guidance framework, it is intended to provide standards that foster quality and consistency in the processes for developing, testing and regulating these new genetic technologies. Best practices recommended in the 2021 guidance framework will further contribute to the comparability of results and credibility of conclusions in order to facilitate decision-making by countries interested in the potential use of GMMs as public health tools for the control of vector-borne diseases.

---

Gene drives for malaria control and elimination in Africa

African Union Development Agency-NEPAD,  2018-06-15 08:43:01. Link
Report of the High-Level African Union Panel on Emerging Technologies (APET) on Gene Drives for Malaria Control and Elimination in Africa.

---

Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values

6356
U. S. National Academies of Sciences, Engineering, and Medicine,  The National Academies Press,  2016-07-08 20:32:51. Journal
Scientists have studied gene drives for more than 50 years. The development of a powerful genome editing tool in 2012, CRISPR/Cas9,1 led to recent breakthroughs in gene drive research that built on that half century’s worth of knowledge, and stimulated new discussion of the potential applications and implications of gene drive technologies. Just prior to the beginning of this study and since the committee was first convened, scientists published four proofs of concept— one in yeast, one in fruit flies, and two in different species of mosquitoes—that demonstrate the successful development of gene drives in the laboratory, at least in these organisms. Proposed applications for gene-drive modified organisms for basic research, conservation, agriculture, public health and other purposes will likely continue to expand as gene editing tools become more refined. Gene-drive modified organisms are on the horizon. The fast moving nature of this field is both encouraging and concerning. While gene-drive modified organisms hold promise for addressing difficult to solve, persistent challenges, such as the eradication of vector-borne diseases and the conservation of threatened and endangered species, these proposed applications are based on limited proof-of-concept studies. The presumed efficiency of gene-drive modified organisms may lead to calls for their release in perceived crisis situations, before there is adequate knowledge of their ecological effects, and before mitigation plans for unintended harmful consequences are in place. Responding to this fast moving field, the National Institutes of Health (NIH) and the Foundation for the National Institutes of Health (FNIH)2 asked the National Academies of Sciences, Engineering, and Medicine to convene a committee with a broad range of expertise to summarize the scientific discoveries related to gene drives and considerations for their responsible use. Proof-of-concept in a few laboratory studies is not sufficient in and of itself to support a decision to release gene-drive modified organisms into the environment. Laboratory and field research is needed to refine CRISPR/Cas9-based gene drives and other gene drive mechanisms, and to understand how gene drives might work under different environmental conditions and in a wide variety of organisms. The considerable gaps in knowledge about potential off-target (within the organism) and non-target (in other species or the environment) effects necessitate a collaborative, multidisciplinary approach to research, ecological risk assessment, development of public policy, and decision making for each proposed application of a gene drive technology. General principles to guide responsible practices for gene drives from the laboratory setting through to field release and monitoring are embedded as recommendations throughout the report.

---