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Preventing Biosecurity Risks Posed by Next-Gen Benchtop DNA Synthesizers
Abstract
Benchtop DNA synthesizers enable rapid, decentralized creation of long DNA sequences, posing biosecurity threats. To prevent misuse, such as from bioengineered pathogens with pandemic potential, we need to apply anticipatory governance and standardized biosecurity safeguards in order to prevent secret unauthorized synthesis of virulent pathogens by malicious actors. Just as portable Next-Gen sequencing platforms like Nanopore and Illumina have improved accessibility and decentralization of DNA sequencing, Next-Gen benchtop DNA synthesizers are also doing the same for DNA synthesis. Although they promise significant advancements in synthetic biology, they also pose biosecurity risks if misused. With the current increased research and investment in benchtop DNA synthesizers by manufacturers, this will lead to rapid advances in decentralized DNA synthesis. This calls for anticipatory governance to address the dual-use concerns that this technology raises. It requires proactive policy development and thus the need for early attention to this matter when control is still easy. This paper therefore discusses and shows the history, advancements and regulatory gaps in DNA synthesis technologies. It explores the biosecurity implications and proposes a new policy roadmap model that can be used to proactively govern and therefore mitigate risks posed by benchtop DNA synthesis technologies. According to this roadmap, it describes short-, medium-, and long-term regulatory strategies, ranging from real-time sequence monitoring to the integration of AI-powered sequence analysis systems, along with licensing requirements for users and blockchain-based DNA tracking. As opposed to existing voluntary frameworks, such as those of the International Gene Synthesis Consortium (IGSC), whose emphasis is on centralized gene synthesis companies, our model extends governance to device manufacturers and users. Also, our policy addresses decentralized risks through mandatory user authentication and sequence restriction mechanisms, in contrast to the US Framework for Nucleic Acid Synthesis Screening, which targets centralized providers. This suggests proactive policy developments that can prepare for governance of the decentralized nature of DNA synthesis by benchtop devices in comparison to the centralized method that has some voluntary regulations by DNA synthesis companies which are working to prevent biosecurity risks. This paper therefore highlights the importance of balancing scientific innovation responsibly with international health security by incorporating these safeguards on this dual use technology.
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