Scientists rely on gene synthesis technologies as a research tool for everything from basic research to vaccine development and drug target identification. Oligonucleotides, which are pieces of DNA about 15 to 30 base pairs long, are used in gene synthesis laboratories all over the world, along with DNA strands that may be thousands of bases long.
Ever since the inception of gene synthesis, there have been concerns about possible misuse of synthetic genes. Pathogens — particularly small viruses — could be assembled from scratch in a lab, evading the regulatory regimes the U.S. and many other nations have in place to control unauthorized access to dangerous pathogens. The National Academies of Sciences, Engineering, and Medicine listed the synthesis of known pathogens, particularly small viruses, as one of the most pressing biodefense risks in a 2018 report.
To be sure, progress has been made to reduce these risks. The Department of Health and Human Services published guidance in 2010 for commercial gene providers which included screening orders to ensure that unauthorized people weren’t ordering genetic material found in dangerous pathogens and screening customers to ensure that people weren’t paying for orders with cash or having them sent to P.O. boxes. Yet changes both in technologies and market conditions have reduced the effectiveness of these biosecurity protections, raising questions about whether the HHS guidance should be updated and what else can be done to increase biosecurity protections.
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