Comprehensive matrices for regulatory approvals and genetic characterization of genetically modified organisms

The production of new types of genetically modified organisms (GMOs) and the use of products containing or derived from these materials are expanding globally. This poses a challenge in providing cost-effective comprehensive analyses. In this line, the state of art testing approaches rely on a matrix representing the GM events with their corresponding GM markers - DNA elements used in plants' transformation. Accordingly, this study aimed first at constructing an updated and comprehensive matrix of genetic characterization of GM events based on an extensive review of the relevant databases. Inclusive lists of 356 GM markers and 508 events in 29 plant species were compiled and organized into a matrix. The frequency of occurrence of these elements was then determined. Moreover, for the first time, a matrix representing the regulatory status of every compiled GM event was established. Remarkably, numerous inconsistencies were detected among the databases at the levels of nomenclature, events' registry, molecular characterization and regulatory approvals. Both matrices represent a useful tool for comprehensive and cost-effective analyses. The genetic matrix permits designing the most straightforward testing strategy that provides the maximum information about GMOs in a sample in the minimum number of experimental steps. Moreover, the novel regulatory matrix, allows further decreasing the number of required event-specific identification tests by giving higher probabilities to those authorized in the samples' country of origin. Finally, the genetics and regulatory matrices represent the building-block for establishing an inclusive automated database for GMOs which is instrumental for testing laboratories worldwide.