Evaluation of a successful launch of the MammaPrint and BluePrint NGS kit

Background Centralized MammaPrint (MP) and BluePrint (BP) microarray-based genomic tests on FFPE RNA were succesfully translated to a targeted RNA NGS kit that can be performed locally in decentralized sites. Since the launch of the CE-marked MP and BP NGS test, more data has been generated on this platform as well as on the established FDA-cleared microarray platform. Furthermore, decentralized sites worldwide have been onboarded and are certified to locally run the MP and BP NGS test. Methods Paired MP and BP results were generated from FFPE RNA samples using the standard microarray as well as the MP and BP NGS test. The results from both platforms were compared to assess the concordance. Since the launch of the MP and BP NGS kit several decentralized sites underwent the onboarding process. As part of the onboarding, these sites processed a set of RNA and FFPE tissue samples previously processed at Agendia using the MP and BP NGS test. A site could only be certified if NGS results showed a 100% concordance with the Agendia results. Results To date, over 150 RNA FFPE samples were processed with both microarray and NGS tests and MP/BP results showed concordance above 97%. Onboarding results were available for the decentralized sites. The FASTQ files generated at the sites were uploaded into the cloud-based Agendia Data Analysis Pipeline Tool (ADAPT) to generate MP and BP results. Results showed 100% concordance between Agendia’s central laboratory and the decentralized laboratories. Conclusions MP and BP NGS test delivers equivalent results to the standard microarray test. Additionally, NGS results generated at decentralized sites also show extremely high concordance. These results confirm the high quality and robustness of the MP and BP NGS test. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure L. Delahaye: Full / Part-time employment: Agendia. A.T. Witteveen: Full / Part-time employment: Agendia. M. Snel: Full / Part-time employment: Agendia. T. Cavness: Full / Part-time employment: Agendia. B. Chan: Full / Part-time employment: Agendia. L. Mittempergher: Full / Part-time employment: Agendia. A.M. Glas: Full / Part-time employment: Agendia.