Where lab-made DNA is created — and barely policed

Almost 20 years ago, James Randerson ordered a sequence of smallpox DNA. Smallpox is the only human disease to have ever been successfully eradicated — 46 years ago as of yesterday. It’s one of the deadliest infections in human history, killing about 500 million people over three millennia — with 300 million of those deaths estimated to have occurred in the last century alone.

If someone — like a disgruntled scientist, terror group, or rogue nation — were to synthesize and unleash smallpox, we could see the reemergence of a disease that killed three out of 10 people it infected, one that the vast majority of humanity is now no longer protected against.

Thankfully, Randerson was a journalist for The Guardian writing an exposé on the lax customer screening policies of DNA synthesis companies, rather than an aspiring bioterrorist.

“All it took was a[n] invented company name, a mobile phone number, a free email address and a house in north London to receive the order by post,” Randerson wrote.

In the nearly 20 years since, the field has grown massively. DNA synthesis is a cornerstone of modern biotechnological research: Scientists order synthetic DNA to develop gene therapies, engineer bacteria to improve agricultural output, create new vaccines, and much more.

But when you can order certain genetic sequences, you can potentially build harmful pathogens as well. Companies need to ensure that they aren’t sending the building blocks of a possible bioweapon to malicious actors, but the demand for synthetic DNA is growing worldwide. It’s never been cheaper — or easier — to write genetic code. And regulations and the ability to institute safeguards vary significantly depending on where you are.

That’s why the International Biosecurity and Biosafety Initiative for Science (IBBIS), an NGO dedicated to safeguarding modern bioscience and biotechnology, launched the Global DNA Synthesis Map on Tuesday at a side event at the Biological Weapons Convention working group at the United Nations in Geneva.

The interactive map draws upon data from more than 80 countries to highlight their screening practices, regulatory frameworks, and access to DNA synthesis.

“When we started this project a year ago, there was no comprehensive overview of the DNA synthesis landscape,”Mayra Ameneiros, a senior fellow at IBBIS and the map’s project lead, told me. It’s the first public and continuously updated look at where DNA synthesis providers operate around the world, including not just the major players like China and the US, but previously neglected regions like Latin America and Africa.

The map currently shows 1,023 DNA synthesis companies operating across 81 countries. It also spotlights regions with established regulatory frameworks and DNA synthesis screening requirements, allowing users to compare countries and territories with each other and notice where gaps exist.

And companies can benefit from paying attention to gaps that the map highlights. “For the private sector, this is important because companies could face legal consequences if they unknowingly sell a risky sequence to a bad actor,” Ameneiros said. “If something goes wrong, the company that made the sale will always be held responsible.”

The map reveals that only 10 percent of synthetic DNA providers currently screen for DNA sequences of concern, meaning that companies could be sending out the makings of a dangerous pathogen. That’s a tremendous biosecurity gap. More than 700 companies provide synthetic nucleic acids, the building blocks of genetic material, and benchtop DNA synthesis devices, which allow scientists to synthesize custom DNA sequences in their own labs rather than ordering it from a commercial provider. More than 500 of those companies need to screen orders to guarantee compliance with local regulations.

But effective screening could become more challenging as DNA synthesis technologies are becoming increasingly decentralized. With the advent of benchtop DNA synthesis devices, people don’t even have to wait for their orders to arrive to start using the synthetic DNA. More people can have access to this technology than ever before. This is of particular concern in the Global South, where there are often fewer regulations.

And then there’s the effect of AI, which can enable the design of novel DNA sequences. That can speed up the pace of life-saving gene therapy development — but it can also help facilitate the creation of novel pathogens. And just as we can use AI to improve screening, it can also be used to evade existing screening software tools.

As these technologies improve and become more accessible, they must be increasingly safeguarded as the barrier to entry to weaponize them decreases. Keeping sequences of concern out of potentially dangerous hands becomes that much more important, and the map aims to facilitate that.

Ultimately, IBBIS hopes the map, which will be continually updated as a live resource, will inform standards around best screening practices, with the aim of eventually turning a dizzying patchwork array of regulations into a workable international standard. Without one, the world will be in much greater danger from lab-made pathogens than it was when James Randerson ordered smallpox sequences to his home nearly 20 years ago.

A version of this story originally appeared in the Future Perfect newsletter. Sign up here!