Makery

Germany launches a legal battle against the DIYbio CRISPR-Cas9 kit

The Odin’s CRISPR-Cas9 DIY kit was a 2017 finalist in the Interactive Innovation Awards at the SXSW festival. © The Odin

Published 4 April 2017 by

The incredible story of The Odin’s CRISPR-Cas9 gene-editing kit, which travels across the Atlantic and sets off the first legal-sanitary counter-attacks.

The least one can say is that The Odin (Open Discovery Institute) biohackers like playing with fire. In autumn 2015, in the heat of a raging scientific-legal war around the authorship of a patent on gene surgery, they crowdfunded over $70,000 on Indiegogo to develop a DIY gene-editing kit based on the revolutionary technique CRISPR-Cas9.

Ever since it was discovered in 2012, the technique has become the economic stake of the decade in biotechnologies. Described as the “Swiss army knife” of genetics, CRISPR-Cas9 can be used to eliminate and add fractions of genetic material with extreme precision. Its many applications could eradicate pandemics. But the current debate about disseminating the results of this “genetic forcing” remains unresolved. While U.S. and European laws are cautious, since 2015 China has been leading controversial experiments on embryos, or to resist the AIDS virus. The first test on a human patient diagnosed with lung cancer in October 2016 was also done in China.

Indiegogo campaign for Josiah Zayner’s (The Odin) CRISPR-Cas9 kit in 2015:

Citizen science or bio-terrorism?

As using these “genetic scissors” is relatively easy and inexpensive, The Odin’s Californian troublemaker Josiah Zayner (already notorious for his DIY fecal transplant) released a $150 kit in late 2015 to democratize the technique. But just as The Odin was preparing the first kits and merchandizing to reward its contributors, in February 2016, the director of the U.S. Defense Intelligence Agency (DIA) James R. Clapper classified these new genome-editing tools as “weapons of mass destruction”. Without being explicitly named, CRISPR-Cas9 system was in the line of fire. Whether it fell into the hands of bioterrorists or irresponsible biohackers, the possibilities it raised were enough to challenge its mass distribution in the eyes of the DIA.

Nevertheless, in the name of citizen science, The Odin proceeded to send out its kits to those who had pre-purchased them and systematically commercialized them worldwide by summer 2016.

Crowdfunding T-shirt reward from The Odin. © The Odin

Upon which, in October 2016, the customs office of Munich in Germany, whose legislation is reputedly strict on these matters, ordered a The Odin kit to edit Escherichia (E.) coli HME63 from agar, a priori classified no risk category 1 in the U.S.

Last February, CRISPR came under fire again due to legal rebound, as the U.S. Broad Institute won the second round of the patent battle. Despite the media frenzy, everything seemed to be going well for The Odin, whose kit is even selected as a finalist for the Interactive Innovation awards under “health, med & biotech” at the tech mecca of South by Southwest in Austin, Texas.

But the day after the festival, a German journalist sent The Odin a document of results analysis from the Bavarian Bureau of health and food security, dated March 15, indicating that the kit contained toxic category 2 bacteria (intimate bacteria that anybody boarding a plane could transport with them…) and that it would be prohibited on German soil, while lawsuits would ensue for the exportation of E.coli not in compliance with current German laws. The same bureau released an alert against using the kit in schools. Zayner immediately wrote to the Bavarian officials, who confirmed their decision a few days later. On March 27, Zayner published an open letter with his argument in defense.

CRISPR in the kitchen

Interesting fact: the document leaked from the Bavarian lab mentions in the last line an event organized in Garching, near Munich, on March 13-17, the CRISPR.kitchen retreat, where the “kit may be presented in demonstration”. Could this event have alerted the Bavarian authorities? CRISPR.kitchen aims to “imagine the future of gene editing, be inspired by scenarios, consult the manual for recipes, evaluations and recommendations”. During a first workshop in mid-March hosted by the very serious Institute for Technology Assessment and Systems Analysis (KIT-ITAS) at the Karlsruhe Institute of Technology, 20 transdisciplinary researchers selected by a call for projects congregated to listen to conferences by top-level experts in bioethics, CRISPR bioinformatics, GMO regulation, etc. The participants then imagined science-fictional scenarios and presented them to the university.

During the meetings, the group discussed legal issues regarding genome editing with an official from the federal government and representatives of Bavaria. To do so, the CRISPR.kitchen team had ordered The Odin’s CRISPR-Cas9 kit online and exhibited it without removing it from the box. They didn’t expect that the authorities would respond unilaterally. A few days after the workshop, CRISPR.kitchen was informed that the same individuals who had come to discuss legal issues had officially stated that their own kit was contaminated.

The DIYbio community gets involved

The Odin argues that the contamination could have occurred at any time, between the time it was shipped in October and its analysis several months later, but recognizes that it did not indicate an expiry date for said kit. The discussion thread is lively on Josiah Zayner’s Facebook page. Urs Gaudens aka GaudiLabs suggests using standard baking powder with an expiration date instead of E. coli agar.

ITAS, in the course of its research on evaluating synthetic biology technologies, claims that it has worked responsibly with the DIYbio community for the past five years. In order to clarify the problems with The Odin kit, the university set up a volunteer committee dedicated to collecting information to evaluate and learn more about the incident: “We want to help the community to verify their own materials and methods and develop better standards and procedures to guarantee a safe and lawful use thereof. We are currently assessing the results of the Bavarian authorities as well as quality assurance data from the company The Odin.”

The preliminary results will be presented at the Biofabbing conference on May 10-14 at Cern in Geneva, and a final report will be published this summer during the last CRISPR.kitchen meeting at Fablab Berlin. Amidst this incredible story, Josiah Zayner has this to say: “When knowledge becomes outlawed, only outlaws will have knowledge.”

Follow the affair: The Odin and CRISPR.kitchen