The state-of-the-art technology for detection and quantification of genetically modified (GM) material is real-time PCR (polymerase chain reaction), usually with hydrolysis probes (TaqMan^®). The most widely grown GM crop is the soybean event GTS40-3-2 (RoundupReady^®).

“The paper was the first to report on a specific real-time PCR method for a single genetically modified (GM) event, in this case the event was GTS40-3-2 and the method uses TaqMan chemistry.”

The paper was the first to report on a specific real-time PCR method for a single GM event, in this case the event was GTS40-3-2 and the method uses TaqMan^® chemistry. It has therefore become a landmark paper in the field of GM material detection.

Does it describe a new discovery or a new methodology that’s useful to others?

Yes, the method is widely used, and has proven to be very reliable also in method comparison studies. The paper also presents additional valuable information related to the real-time PCR-based limits of detection and quantification.

  Could you summarize the significance of your paper in layman’s terms?

The paper was the first to describe a method representing what has since become the state-of-the-art technology for quantitative GMO detection. The GMO that the method detects is by far the most widely grown GMO in the world, with approximately 60% of the global soybean market.

  How did you become involved in this research and were there successes or failures?

Our laboratory is the national reference laboratory for GMOs, and research and development is our main activity. We therefore searched for collaborators throughout Europe when the European Union published a call for proposals for development of GMO detection methods in the 5th Framework Programme in 1998. Through parallel activities in the European Committee for Normalization (CEN) we met with several of the European experts in the field of GMO testing and discussed ideas.

The end of the story was that I became the coordinator of a 13-partner, 3-year collaborative research project in which we elaborated on a generalized concept for provision of a reliable analytical traceability package comprising: sequence characterization of the integrated transgene construct and flanking sequences, providing a better basis for a comprehensive risk assessment and for development of event specific detection methods development of event specific quantitative real-time PCR methods permitting discrimination between, e.g., authorized and non-authorized events expressing the same trait (novel protein) reliable, single copy reference gene-specific quantitative real-time PCR methods, to determine the quantity of each ingredient (species) in a sample DNA-based reference materials for calibration and method validation collaborative trial validation of methods.

The concept and the experience accumulated by the project partners have since had a very strong impact on the current EU regulations on GMOs, in particular Regulation EC/1829/2003.

There were many difficulties, and one of the major difficulties was the lack of collaboration from the biotech industry. It was almost impossible to obtain samples/reference materials for the research and development activities. Since then, the provision of both reference materials and a collaborative trial validated quantitative detection method become mandatory for companies who apply for authorization of their GMOs in the EU.

  Where do you see your research leading in the future?

Since the detection methods are now provided by the companies and validated by the Community Reference Laboratory for GMOs, we have directed our research towards development of advanced multiplex detection methods and other technical challenges.

In the ongoing EU funded research project called "Co-Extra" our laboratory is currently focusing on several of these challenges. I would like to highlight one: development of methods for detection, identification, and characterization of unauthorized GMOs.

Recent events in the USA, such as the contamination of rice with the unauthorized event LLRICE601 and the marketing over several years of seeds of the maize event Bt10 which had never been subject to an official risk assessment in any country, exemplify why we need methods to detect unauthorized GMOs. The methods we are developing include high-density microarray-based methods to detect GMOs that have been transformed with completely new combinations of genetic elements.

In other research projects, we focus on mechanisms of uptake and possible integration of dietary DNA, and of possible toxic effects related to the structure and quantity of DNA in food and feed from various sources. With time, we will probably further increase our focus on the biological mechanisms and interactions, at the expense of focus on method development.

  Are there any social or political implications of your research?

Yes, as already explained some of our research has had a strong impact on the present EU regulations, and the European GMO testing regime. This has global impact. It has been claimed that the EU introduced a de facto moratorium on authorization of new GMOs in the period 1998-2004.

The first new authorization after that period concerned Bt11 sweet maize, and the official method for detection of this event in compliance with Regulation EC/1829/2003 was a method developed in our laboratory and published in 2003. Now there are quite some expectations among stakeholders in relation to methods for detection of unauthorized GMOs. And it would be impossible for the stakeholders to verify if products on the market comply with the regulations without reliable detection methods, so our research is also important to maintain public trust in key stakeholders like policy makers, the food industry, and enforcement authorities.