Event-specific method for the quantification of maize DAS-40278-9 by real-time PCR : validation report and validated method

In line with its mandate the European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), in collaboration with the European Network of GMO Laboratories (ENGL), has validated an event-specific polymerase chain reaction (PCR) method for detecting and quantifying maize event DAS-40278-9 (unique identifier DAS-4Ø278-9). The validation study was conducted according to the EU-RL GMFF validation procedure [http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm] and the internationally accepted guidelines. In accordance with current EU legislation1, Dow AgroSciences LLC has provided the detection method and the positive and negative control samples (genomic DNA from maize seeds harbouring the DAS-40278-9 event as positive control DNA, genomic DNA from conventional maize seeds as negative control DNA). The EU-RL GMFF prepared the validation samples (calibration samples and blind samples at different GM percentage [DNA/DNA]), organised an international collaborative study and analysed the results. The study confirms that the method meets the method performance requirements as established by the EU-RL GMFF and the ENGL in Annex I-2.C.2 to Regulation (EC) No 641/20041 and it fulfils the analytical requirements of Regulation (EU) N°619/2011. This report is published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm