Published online 18 November 2009 | Nature | doi:10.1038/news.2009.1095

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Gene-makers form security coalition

Latest salvo in the gene-synthesis 'standards war' sees firms set up a competing code.

DNADangerous DNA: synthetic-biology companies are trying to ensure that their products are not misused.Alamy

A new coalition of synthetic-biology companies, named the International Gene Synthesis Consortium (IGSC), has created its own set of guidelines that are intended to lessen the risk that gene-synthesis technology could be misused.

The development is the latest in a synthetic-biology 'standards war' over just how rigorous companies should be when screening incoming DNA orders for their potential to create dangerous pathogens. A rift in the industry opened in August, when two of the companies that are now part of the new consortium — Geneart of Regensburg, Germany, and DNA2.0 of Menlo Park, California — said that they would break with an effort by the International Association of Synthetic Biology (IASB) to develop gene-synthesis screening standards. But despite the break, the new consortium's standards are similar to those of the Germany-based IASB.

The IASB's code of conduct commits its member companies to checking all incoming orders against the Genbank sequence database. Any 'hits' for sequences that might be hazardous are referred to human screeners, who determine whether the customer is legitimate and whether the order should be filled. These same principles are enshrined in the 'harmonized screening protocol' of the new consortium, which commits companies to screening orders against both a large sequence database and a database of government-regulated pathogenic genes, currently being developed. This marks a change from the earlier position taken by Geneart and DNA2.0, which was that no human follow-up would be necessary after an automated database screen.

"I'm quite happy, because the whole document looks very similar to the code of conduct that we finalized," said Markus Fischer, a member of the IASB board. "The thing that irritates me a little bit is that since it is so similar, they could have signed up to the code of conduct and achieved the same result."

Market force

The four companies that make up the IASB have signed its code of conduct, as has Shanghai Generay Biotech in China, along with a consultancy run by Joseph Kittle, chairman of the Synthetic Biology Industry Association, a US-based equivalent to the IASB. Fischer says that the IASB is in talks with other companies, including large pharmaceutical firms such as AstraZeneca, which has supported the process of developing the code.

“The whole document looks very similar to the code of conduct that we finalized.”

Markus Fischer
International Association of Synthetic Biology

The IGSC, which in addition to Geneart and DNA 2.0 includes the gene-synthesis firms Blue Heron Biotechnology of Bothell, Washington; GenScript of Piscataway, New Jersey; and Integrated DNA Technologies of Coralville, Iowa, contends that its large market share gives it the experience to decide on workable screening measures. "I think what the IASB is doing is great, but we do have a perspective about the scale of the gene-synthesis industry, which helps us to decide what are practically implementable solutions," said Jeremy Minshull, president of DNA2.0. The group says that it represents 80% of the global gene-synthesis industry, although it is not possible to verify that number because most of the companies are privately held.

Now, other companies in the industry will need to decide whether they will sign up to either standard, or devise their own. Opting out completely is not seen as a viable solution — it is widely expected that the US government, which is developing its own screening guidelines, will ask gene-synthesis companies to take steps to deal with biosecurity risks. The government's standards are expected soon, and will be discussed at the 3 December meeting of the National Science Advisory Board for Biosecurity in Bethesda, Maryland, according to Elleen Kane of the US Department of Health and Human Services.

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One difference between the two standards that could influence other companies' decisions is how open each group is to public discussion of its standards. The IGSC contends that its large market share will pull companies to its standard, but Fischer points out that smaller companies may prefer to join a consortium with a standard that is more responsive to their concerns.

But no matter what other companies do, Fischer says the fact that the industry is converging on similar practices to deal with security risks is encouraging. "We've taken a lot of the risk out of gene synthesis, and we can now say that we're conducting this business responsibly," Fischer says. "This could prevent the sorts of public perception problems that Europe has had, for instance, with the GMO [genetically modified organism] debate in the past, and that's a good thing for the whole community, including the scientists." 

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  • #60081

    The USA is so great at spending money on virtually non-existent threats. Not that I am against the evolution of mankind in any way. But the reason why the DoD needs it is not quite that obvious.

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