In an era when Washington seems incapable of finding common ground on virtually any issue, it’s notable to encounter a policy area where stakeholders across the political spectrum agree. Gene synthesis screening has emerged as one of those increasingly rare issues with genuine bipartisan momentum, where economic and security interests and industry expertise all point in the same direction. A recent bipartisan bill, the Biosecurity Modernization and Innovation Act, outlines an ambitious vision for comprehensive gene synthesis screening standards. To understand why this matters, we need to start with the technology itself.
The biotechnology sector has become a cornerstone of American economic competitiveness, driving breakthroughs in medicine, agriculture, and advanced manufacturing that position the United States at the forefront of global innovation. Critical to this progress are synthetic nucleic acids — custom DNA and RNA sequences that researchers can design on a computer and order like any other lab supply, with the sequences synthesized and shipped directly to their facilities. The sequences can then be used to develop new medicines, engineer improved crops, and advance our understanding of biological systems.
This technology’s impact is reflected in the numbers. The U.S. DNA synthesis market was valued at $1.60 billion in 2024 and is projected to reach $9.30 billion by 2034. The U.S. controls 55% of the global market, specializing in high-end, high-complexity applications. This leadership position matters beyond economics: as the National Security Commission on Emerging Biotechnology warned in its 2025 report, countries mastering biotechnology “will gain tremendous strength and prosperity” and “get to shape how these technologies are used for decades, if not centuries, to come.”
But America’s biotech leadership depends on more than just market share — it requires safeguarding the technology from misuse. The ease of ordering synthetic DNA means that the same tools enabling legitimate research could potentially be misused to create harmful biological agents. Moreover, as artificial intelligence transforms protein design capabilities, bad actors might exploit these advances to engineer dangerous sequences that traditional safeguards are ill-equipped to catch. The potential for such misuse was demonstrated in a recent Science study. Researchers led by Microsoft found that AI-powered protein design tools could create potentially dangerous variants of concerning proteins that were sufficiently different from known threats to evade the screening software used by DNA synthesis companies — a type of vulnerability that current safeguards weren’t designed to address. After the software developers were alerted to these gaps and improved their screening tools, detection rates improved dramatically, flagging all but roughly 3% of problematic sequences in subsequent testing. While this study raises concerns, it also demonstrates something encouraging: industry’s willingness and ability to rapidly address security gaps when they’re identified.
The groundwork for comprehensive screening already exists, and it’s been built by industry itself. The International Gene Synthesis Consortium, formed in 2009 as an industry-led group, represents a majority of global commercial synthesis capacity and has developed voluntary screening protocols. American synthesis companies that lead in safety and security also command the largest market shares. Industry stakeholders have recognized that effective governance protects their business interests while addressing security concerns. Providers understand their long-term success depends on maintaining public trust and preventing misuse that could trigger overly restrictive regulation.
So the obstacle to implementing effective policy isn’t industry resistance. On the contrary, it’s a lack of standardized requirements, which creates an uneven playing field. Companies that invest in robust screening bear costs that their less conscientious competitors avoid. Screening requirements applied to all providers serving U.S. customers would effectively set global standards, including for Chinese synthesis companies seeking American market access. Rather than handicapping domestic industry, mandatory screening protects it: companies meeting U.S. security standards gain a competitive advantage, while those unwilling to comply lose access to the world’s largest synthesis market.
Rather than creating new regulatory frameworks from scratch, the path forward involves codifying what responsible companies are already doing voluntarily. Indeed, this transition from voluntary industry standards to comprehensive requirements has been building momentum for over a decade. In 2010, the Department of Health and Human Services issued the first comprehensive federal guidance for screening gene synthesis orders, establishing baseline responsibilities for providers. The Biden administration’s 2024 Framework for Nucleic Acid Synthesis Screening built on this foundation, requiring federally funded entities to purchase synthetic nucleic acids only from providers adhering to screening standards.
The Trump administration has accelerated this momentum. The May executive order on Improving the Safety and Security of Biological Research directed the Office of Science and Technology Policy to incorporate enforcement mechanisms in the 2024 framework. More significantly, it requires developing a strategy to achieve comprehensive screening in non-federally funded settings, addressing the current coverage gap. The administration’s AI Action Plan also highlights gene synthesis screening as a critical safeguard as artificial intelligence technologies reshape the risk landscape.
Rare in today’s political environment, we have also seen congressional action across party lines. Most recently, Sen. Tom Cotton (R-AR), joined by Sen. Amy Klobuchar (D-MN), introduced the Biosecurity Modernization and Innovation Act, taking a comprehensive approach that requires mandatory screening for all synthesis providers selling to U.S. customers, establishes conformity assessment systems with auditing and adversarial testing, and directs a government-wide assessment of biosecurity authorities to streamline oversight.
But the Cotton bill isn’t alone. The bipartisan Nucleic Acid Standards for Biosecurity Act directs the National Institute of Standards and Technology to develop technical standards for screening accuracy and operational security. The Securing Gene Synthesis Act establishes mandatory screening protocols with verification systems and requires federal agencies to purchase only from verified providers. Sens. John Hickenlooper (D-CO) and Ted Budd’s (R-NC) Gene Synthesis Safety and Security Act, which establishes screening requirements and guidance for nucleic acid synthesis providers, was included in the Senate’s 2023 PAHPA package.
The bipartisan support reflects a shared understanding that security and innovation can advance together. The building blocks for comprehensive gene synthesis screening already exist. What remains is closing the gap — extending effective screening standards across the entire market, not just federally funded research. The executive actions, legislative proposals, and industry standards described above converge on several critical elements: establishing robust verification through conformity assessment rather than paper compliance, addressing split-order vulnerabilities through information-sharing mechanisms, and reducing minimum screenable fragment lengths from 200 to 50 nucleotides to close exploitation gaps.
CHINA IS ALREADY WAGING WAR ON AMERICAN SOIL
These improvements aren’t just theoretical but concrete steps that build on existing industry capabilities while leveling the playing field for security-conscious companies. The framework exists. The industry is ready. The legislative momentum is building. What remains is extending proven screening standards across the entire market before emerging capabilities outpace our safeguards.
Dr. Anemone Franz is a visiting research fellow at the American Enterprise Institute, where she focuses on biosafety and biosecurity.
