Steph Batalis & Vikram Venkatram
Imagine you work for a hypothetical gene synthesis company, one of dozens around the world that manufacture tiny strands of custom nucleic acids like DNA for customers in academia and industry. DNA isn’t just the basis for life on Earth—it’s also the basis of many research laboratories. Plastic tubes of DNA are a familiar sight for many researchers, from students in undergraduate biology labs to scientists in pharmaceutical development facilities. Scientists’ capacity to perform genetic engineering, design new medical tests and therapies, and understand gene functions has skyrocketed thanks to the ability to design specific DNA sequences that meet particular research goals.
Along with new possibilities, however, the ability to custom-order genes also has the potential to open up new risks. Some DNA codes for genes from pathogens and toxins—sequences that could cause harm if misused. To limit such an outcome, experts from industry, government, and academia recommend screening orders and customers before filling an order.
In the United States, this screening is at a pivotal moment. A Biden administration executive order that would require researchers working with federal funds to order from companies that screen DNA orders was short-lived; the Trump administration rescinded the requirement less than three months after it went into effect. While many of the leading synthesis companies are committed to voluntarily screening orders as members of an industry-led consortium, the revoked executive order would have marked the first time that the practice was made standardized and compulsory. Since the new administration may retain some aspects of the Biden executive order, it remains unclear what the status of screening requirements will be moving forward.
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