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Risk management recommendations for environmental releases of gene drive modified insects

Y. Devos, J. D. Mumford, M. B. Bonsall, D. C. M. Glandorf and H. D. Quemada,  Biotechnology Advances,  2021.
The ability to engineer gene drives (genetic elements that bias their own inheritance) has sparked enthusiasm and concerns. Engineered gene drives could potentially be used to address long-standing challenges in the control of insect disease vectors, agricultural pests and ...
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Combating mosquito-borne diseases using genetic control technologies

G.-H. Wang, S. Gamez, R. R. Raban, J. M. Marshall, L. Alphey, M. Li, J. L. Rasgon and O. S. Akbari,  Nature Communications,  12:4388. 2021.
Mosquito-borne diseases, such as dengue and malaria, pose significant global health burdens. Unfortunately, current control methods based on insecticides and environmental maintenance have fallen short of eliminating the disease burden. Scalable, deployable, genetic-based ...
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Efficacy of Wolbachia-Infected Mosquito Deployments for the Control of Dengue

A. Utarini, C. Indriani, R. A. Ahmad, W. Tantowijoyo, E. Arguni, M. R. Ansari, E. Supriyati, D. S. Wardana, Y. Meitika, I. Ernesia, I. Nurhayati, E. Prabowo, B. Andari, B. R. Green, L. Hodgson, Z. Cutcher, E. Rancès, P. A. Ryan, S. L. O’Neill, S. M. Dufau,  New England Journal of Medicine,  384:2177-2186. 2021.
BACKGROUND Aedes aegypti mosquitoes infected with the wMel strain of Wolbachia pipientis are less susceptible than wild-type A. aegypti to dengue virus infection. METHODS We conducted a cluster-randomized trial involving releases of wMel-infected A. aegypti mosquitoes for the ...
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Guidance framework for testing of genetically modified mosquitoes, second edition

WHO,  WHO-TDR,  2021.
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 ...
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Selection of Sites for Field Trials of Genetically Engineered Mosquitoes with Gene Drive

G. C. Lanzaro, M. Campos, M. Crepeau, A. Cornel, A. Estrada, H. Gripkey, Z. Haddad, A. Kormos, S. Palomares and W. Sharpee,  bioRxiv,  2021.04.28.441877. 2021.
Novel malaria control strategies using genetically engineered mosquitoes (GEMs) are on the horizon. Population modification is one approach wherein mosquitoes are engineered with genes rendering them refractory to the malaria parasite coupled with a low-threshold, Cas9-based gene ...
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Ecological Relationships of Mosquito Disease Vectors: Anticipating Risk Assessment of Gene Drive Technologies

Stephanie James, Hector Quemada and David O'Brochta,  GeneConvene Global Collaborative,  2021.
An often-raised concern for the development of genetically modified mosquito technologies, particularly those involving gene drive, as tools to prevent disease transmission is the limitation of our understanding of the roles these species may play within the ecosystem. This ...
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US Gene Drive Governance: A Special Feature in Health Security

L. Warmbrod, A. Kobokovich, R. West, G. K. Gronvall and M. Montague,  Health Security,  19:131-132. 2021.
The novel potential of gene drives and related genetic pest control measures highlights a gap in the oversight of products using such technologies in the United States. The US Coordinated Framework for Regulation of Biotechnology, as applied by US Environmental Protection Agency, ...
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Systematic identification of plausible pathways to potential harm via problem formulation for investigational releases of a population suppression gene drive to control the human malaria vector Anopheles gambiae in West Africa

J. B. Connolly, J. D. Mumford, S. Fuchs, G. Turner, C. Beech, A. R. North and A. Burt,  Malaria Journal,  20:170. 2021.
Population suppression gene drive has been proposed as a strategy for malaria vector control. A CRISPR-Cas9-based transgene homing at the doublesex locus (dsxFCRISPRh) has recently been shown to increase rapidly in frequency in, and suppress, caged laboratory populations of the ...
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GeneConvene Webinar Series on: Ecological Modeling in Risk Assessment of Gene Drives

Hector Quemada and David O'Brochta,  ,  2021.
Unlike non-gene drive organisms, which can be limited in time and space and therefore provide data in small scale tests that can be relevant to large scale releases, the potential for large-scale spread from a limited release, even in well-isolated trials, means that reliance on ...
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GeneConvene Webinar Series on: Genetic Biocontrol

David O'Brochta and Hector Quemada,  ,  2021.
In the mid 20th century various ideas emerged concerning how genetics and genetic principles could be directly applied to age-old problems of managing insects that threaten food security and public health. This series of webinars will explore the current state-of-the-art of what ...
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Exploring Gene Drive Technologies in Agriculture, Biodiversity and Human Disease

The GBIRd Partnership and The GeneConvene Global Collaborative,  Gene Drive Research Forum,  2021.
The GBIRd Partnership and The GeneConvene Global Collaborative recently collaborated through The Gene Drive Research Forum, to create and produce an engaging conversation between Drs. Fred Gould and Charles Godfray about gene drive technologies – the potential benefits and ...
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Making gene drive biodegradable

J. Zapletal, N. Najmitabrizi, M. Erraguntla, M. A. Lawley, K. M. Myles and Z. N. Adelman,  Philosophical Transactions of the Royal Society B: Biological Sciences,  376:20190804. 2020.
Here, we consider the inclusion of self-elimination mechanisms into the design of homing-based gene drive transgenes. This approach not only caused the excision of the gene drive transgene, but also generates a transgene-free allele resistant to further action by the gene drive. ...
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Core commitments for field trials of gene drive organisms

K. C. Long, L. Alphey, G. J. Annas, C. S. Bloss, K. J. Campbell, J. Champer, C.-H. Chen, A. Choudhary, G. M. Church, J. P. Collins, K. L. Cooper, J. A. Delborne, O. R. Edwards, C. I. Emerson, K. Esvelt, S. W. Evans, R. M. Friedman, V. M. Gantz, F. Gould,,  Science,  370:1417-1419. 2020.
While field trials of gene drive organisms (GDOs) ultimately will depend on public policy decisions, those engaged in GDO work can play critical roles in support of these decisions by generating evidence and developing evaluation strategies in fair and effective partnerships with ...
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Standardizing the Definition of Gene Drive

L. S. Alphey, A. Crisanti, F. Randazzo and O. S. Akbari,  Proceedings of the National Academy of Sciences,  202020417. 2020.
As members of the gene drive community, we have developed a set of definitions to help stakeholders discuss the topic and communicate using a common understanding of terms.
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Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives

E. Panel o. G. M. Organisms, H. Naegeli, J.-L. Bresson, T. Dalmay, I. C. Dewhurst, M. M. Epstein, P. Guerche, J. Hejatko, F. J. Moreno, E. Mullins, F. Nogué, N. Rostoks, J. J. Sánchez Serrano, G. Savoini, E. Veromann, F. Veronesi, M. B. Bonsall, J. Mumfor,  EFSA Journal,  18:e06297. 2020.
As a proactive measure, the European Food Safety Authority (EFSA) has been requested by the European Commission to review whether its previously published guidelines for the risk assessment of genetically modified animals (EFSA, 2012 and 2013), including insects (GMIs), are ...
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Novel and Exceptional Technology and Research Advisory Committee – NExTRAC -NIH

NIH Office of Science Policy,  National Institutes of Health (NIH),  2020.
NExTRAC provides advice to the Director of the National Institutes of Health (NIH) on matters related to the conduct and oversight of research involving emerging technologies in biomedical science. NExTRAC also makes recommendations on research involving the use of, and ...
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Evaluation of genetically modified mosquitoes for the control of vector-borne diseases

Global Malaria Programme,  WHO - Position Statement,  2020.
In the spirit of fostering innovation, WHO takes the position that all potentially beneficial new technologies, including GMMs, should be investigated to determine whether they could be useful in the continued fight against diseases of public health concern. Such research should ...
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GeneConvene Global Collaborative Webinar Series

David O'Brochta and Hector Quemada,  GeneConvene Global Collaborative,  2020.
This is a series of public scientific and technical seminars by researchers actively involved in the research and development of engineered gene drive and related systems. Presentations will be aimed at other researchers and scientists, highlighting the latest investigations in ...
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A home and rescue gene drive forces its inheritance stably persisting in populations

N. P. Kandul, J. Liu, J. B. Bennett, J. M. Marshall and O. Akbari,  bioRxiv,  2020.08.21.261610. 2020.
We demonstrate that HomeR can achieve nearly ~100% transmission enabling it to persist at genotypic fixation in several multi-generational population cage experiments, underscoring its long term stability.
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Modelling the suppression of a malaria vector using a CRISPR-Cas9 gene drive to reduce female fertility

A. R. North, A. Burt and H. C. J. Godfray,  BMC Biology,  18:98. 2020.
Gene drives based on CRISPR-Cas9 technology are increasingly being considered as tools for reducing the capacity of mosquito populations to transmit malaria, and one of the most promising options is driving endonuclease genes that reduce the fertility of female mosquitoes. Here, ...
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