Within the procurement preparatory phase, the consortium mainly worked on the "Needs" identification defined by the scope of the oncNGS solution, that where further translated into specific solution requirements. Afterwards, the focus was put on the definition of the functional and non-functional oncNGS solution specifications and requirements that were grouped into five parts: clinical workflow, wetlab analysis, bioinformatics analysis (drylab), molecular & clinical interpretation and reporting.
In April the consortium published “The Prior information Notice” (PIN) that announced the upcoming oncNGS Open Market Consultation (OMC).
The OMC was organized in a virtual way and the suppliers that showed an interest in the project and filled a specific questionnaire were offered the opportunity to have an interview with the consortium. During the both OMC events, the received questions were collected, answered by the consortium and published on the oncNGS website under the section FAQ.
In parallel, the consortium developed the business case for the OncNGS solution that was built on a market analysis, the needs of the OncNGS buyers, a literature review and buyer’s experience with liquid biopsies and NGS testing and information gathered by all buyers. The economic modelling that had been conducted reflects buyers’ NGS costing profiles and serves to define the healthcare system investments and savings tied to the implementation of the oncNGS solution.
During this phase, AQuAS initiated the work on the tasks in preparation of Tender documents . Thanks to their expertise in the PCP procedures and a good collaboration from all partners of the consortium, it was successfully accomplished the work regarding the Tender and Validation framework , setting up the different oncNGS criteria with regard to the exclusion, selection, compliance and awarding. Finally, AQuAS in collaboration with all partners set up the evaluation procedure in different oncNGS PCP phases.
Overall work done in this period enabled the consortium to compile it in a final “Call for Tender” (CfT) document.
During the first 6 months in 2021, Declercq & Partners performed a freedom-to-operate (FTO) analysis and IP landscaping on the relevant aspects for the OncNGS project, in particular related to the technology and patent landscape and FTO concerning cancer diagnostic applications of next generation sequencing (NGS) as applied to liquid biopsy materials. Further, also general patent strategy considerations were provided.
Moreover, Sciensano with all buyers gathered background information on how the EC-IVD regulation will be applied within the oncNGS PCP context taking into account that the PCP merely envisages purchasing R&D services to develop the oncNGS solution.
Finally, during this period consortium accomplished an important part of the work with regard to the communication and dissemination activities. Communication plan included a development of an oncNGS website as a main general communication tool. Furthermore, this plan describes how the communication is organized among oncNGS project partners, but also describes the communication of the oncNGS consortium with the EU Commission, the oncNGS stakeholders and community and very importantly, communication with the suppliers.
