Application progress and biosafety challenges of gene editing and synthetic biotechnology in diagnosis, treatment and prevention of infectious diseases
Zixuan Gao, Yuanjiao Gao, Shuojie Wang, Xinxin Li, Weihua Cao, Wen‐Tao Deng, Linmei Yao, Xin Wei, Ziyu Zhang, Shiyu Wang, Yaqin Zhang, Minghui Li, Yao Xie
Abstract
Global infectious disease prevention and control is facing severe challenges due to the frequent emergence of novel pathogens and the rapid mutation of viruses. Synthetic biology, by enabling the engineering of living systems, has offered significant breakthroughs in precise diagnostics, vaccine development, and targeted therapies. However, these advancements are also accompanied by risks related to dual-use potential, biosafety, and ethical concerns. This study conducts a systematic review of literature from 2015 to 2025 retrieved from PubMed, Web of Science, and Scopus, focusing on three key areas: CRISPR-based diagnostics, synthetic vaccines, and engineered probiotics, along with their associated biosafety considerations. In the CRISPR/Cas platform, DETECTR (Cas12a) and SHERLOCK (Cas13a) have been widely applied in detecting pathogens such as SARS-CoV-2 and Ebola due to their high sensitivity, rapid response, and portability. However, the same technologies could be misused to enhance pathogen virulence or develop biological weapons, underscoring the urgent need for strengthened oversight. In the field of vaccine development, mRNA vaccines have emerged as a powerful tool for responding to emerging outbreaks, owing to their design flexibility and efficient production. Nonetheless, challenges remain, including instability, delivery system toxicity, and immune evasion. Viral vector vaccines also raise ecological safety concerns due to the risk of genetic recombination. Engineered probiotics, which leverage programmable genetic circuits to detect pathogens and modulate immune microenvironments, show great promise as “living therapeutics”, yet pose potential risks such as horizontal gene transfer and individual variability. In conclusion, while synthetic biology offers alternatives and enhancements to conventional technologies, its associated risks cannot be overlooked. This paper advocates for the establishment of a global collaborative regulatory framework, the promotion of standardization, and the development of ethical guidelines, providing policy and practical foundations for the safe and sustainable application of synthetic biology in infectious disease control.