Validation of GMO detection methods (GMO validation)

Last updated:
19 August 2013
The purpose of the proposed research is to validate methods of detection for genetically modified organisms (GMOs) developed in a previous FSA project to EU/international standards for enforcement purposes.
Study duration: January 2012 to December 2014
Project code: FS244027
Contractor: National Institute of Biology, Slovenia


Current screening methods for the detection of GMOs are no longer adequate for the detection of all GM constructs now being developed as new sequences and genetic elements are constantly being incorporated. This is especially true for GMOs that have not been risk assessed and authorised within the EU and are thus a potential safety risk.

Screening tests will have to cope with an increasing number of EU-approved GMOs expected over the next few years. In addition, laboratories should also be able to distinguish between material derived from authorised and unauthorised GMOs (UGMs). The increasing number and diversity of GMO traits raises an urgent challenge as both cost and throughput time must be reduced, in order to keep GMO monitoring programmes time- and cost effective for enforcement laboratories.

Research Approach

Within the previous GMOseek project a number of real-time PCR methods were developed. Used with bio-informatics tools for ‘smart screening’ of GMO presence, these methods present great potential to help analysts answer the challenges of GMO detection. This approach was shown to provide wider coverage of authorised and unauthorised GM events, and provide a large amount of information about the GM events present in a sample than currently available methods. In addition, the multiplex methods provide significant cost and time savings.

This project will attempt to fully validate (i.e. with collaborative studies) some of the methods developed within the GMOseek project.

The validation process will consist of three phases for each method:

  • completion of the method in-house method validation
  • proof of transferability to other laboratories
  • a collaborative trial

This project will make validated screening methods available to the community of GMO detection laboratories, both within the EU and further afield. The methods will provide cost effective detection of all authorized GMOs, and reveal the potential presence of UGMs. The methods will be validated according to guidelines derived from the Codex Alimentarius recommendations, and the latest guidance about qualitative methods and thus should be globally acceptable. The detection of authorized GMOs and also UGMs will be more effective and reliable and if extended to all enforcement laboratories in the EU, standardisation of a GMO screening approach will ensure more harmonised GMO testing of the products released on the European market.