Rapid advancements in commercially available DNA synthesis technologies – used for example to artificially create gene sequences for clinical diagnosis and treatment – pose growing risks, with the potential to cause a catastrophic biological security threat if accidentally or deliberately misused.
A new World Economic Forum and Nuclear Threat Initiative report, “Biosecurity Innovation and Risk Reduction: A global Framework for Accessible, Safe and Secure DNA Synthesis,” gathers opinion from a group of global public- and private-sector experts who propose standardized screening practices to counter the threat.
Since scientists demonstrated the means to create a full viral genome in 2002, DNA synthesis technologies have become increasingly available and frequently used by scientists and engineers around the world. These technologies support myriad advancements in synthetic biology, enhancing the efficiency and sustainability of industries including energy, food, agriculture, health and manufacturing. Further advances in technology hold great promise for sustainable development and a safer and more secure society.
At the same time, new approaches to DNA editing and synthesis have made it easier to manipulate biological agents and systems, increasing the risk of a catastrophic accidental or deliberate biological event. These technologies make it possible to create pathogen or toxin DNA that could be misused. For example, in 2018 researchers published work detailing the synthesis of horsepox virus, an extinct virus related to smallpox, using synthetic DNA fragments purchased from a commercial provider. This demonstrated the potential for creating other viruses via commercially available technologies.
Although many DNA providers practice screening procedures, this approach is voluntary and is becoming increasingly expensive. As access expands and the cost of DNA synthesis declines, more DNA is likely to reach the market via additional providers, significantly expanding the user base. In the next two to three years, a new generation of benchtop DNA synthesis machines, enabled by enzymatic DNA synthesis methods, could become available without guidance or norms to prevent misuse.
This report, endorsed by an international expert Working Group, recommends a global system for synthetic DNA screening practices by developing an international, cost-effective, and sustainable mechanism to prevent illicit practices and misuse. The new framework improves the existing voluntary guidelines because it standardizes screening processes, is accessible to new players in the market, and provides valuable feedback data to evaluate the screening – all at lower cost.
“Biotechnology is at the centre of the Fourth Industrial Revolution. To deliver on the promise of the biotechnology revolution, we must seize opportunities to develop and deliver life-advancing innovations while simultaneously and urgently addressing potential risks associated with a growing and democratized bio-economy,” said Arnaud Bernaert, Head of Shaping the Future of Health and Health Care at the World Economic Forum.
The report also proposes that companies, international organizations and governments should explore options for the sustainable oversight and the maintenance of this proposed DNA sequence screening mechanism. DNA synthesis capabilities, in addition to other emerging technologies, can benefit from a larger system of common global life-science norms overseen by a globally recognized entity.
“Global DNA synthesis screening can be a critical tool to reduce the risk that life-science technologies could be deliberately misused to carry out biological attacks or accidentally result in a high-consequence or catastrophic biological event. The time is now,” said Ernest J. Moniz, Co-Chair and Chief Executive Officer of the Nuclear Threat Initiative.