Periodic Reporting for period 1 - oncNGS (NGS diagnostics in 21st century oncology: the best, for all, at all times)
Période du rapport: 2020-01-01 au 2021-08-31
oncNGS consortium challenges the market to research and develop novel and affordable solutions to provide the best NGS tests of liquid biopsy, for all solid tumours and lymphomas patients, forever.
The challenge will consist in providing: (1) efficient molecular DNA/RNA profiling of tumour-derived material in liquid biopsies by means of (2) pan-cancer tumour marker analysis kit including NGS analysis integrated with (3) an ICT decision support system including analytical and molecular test interpretation and reporting for a clinical use.
Thanks to the pre-commercial procurement of innovation, the oncNGS consortium will be able to address their common identified unmet medical needs: (1) Establishment of valuable common tumour profiling strategy allowing to provide equal access to innovative therapies to all; (2) Enable to perform outcome research analysis after treatments with targeted therapies. Diverse testing leads to lowering the pooling capacity of obtained results, needed to obtain large enough sample numbers to perform statistics analyses; (3) Application of such essential testing to all patients, breaking down current unacceptable inequities due to the high costs of current diagnostics tests.
The challenge will consist in providing: (1) efficient molecular DNA/RNA profiling of tumour-derived material in liquid biopsies by means of (2) pan-cancer tumour marker analysis kit including NGS analysis integrated with (3) an ICT decision support system including analytical and molecular test interpretation and reporting for a clinical use.
Thanks to the pre-commercial procurement of innovation, the oncNGS consortium will be able to address their common identified unmet medical needs: (1) Establishment of valuable common tumour profiling strategy allowing to provide equal access to innovative therapies to all; (2) Enable to perform outcome research analysis after treatments with targeted therapies. Diverse testing leads to lowering the pooling capacity of obtained results, needed to obtain large enough sample numbers to perform statistics analyses; (3) Application of such essential testing to all patients, breaking down current unacceptable inequities due to the high costs of current diagnostics tests.
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.
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.
Precision medicine (PM) in oncology relies on tumour molecular screening using NGS to identify actionable molecular alterations aiming at providing more personalized treatment. NGS analyses are performed today in comprehensive cancer center in Europe mainly and the access of patients to molecular testing using large NGS panels is still to be improved.
With respect to profiling the molecular changes invoked in tumorigenic materials in cancer patients, the Buyers Group face the current state of the art limits and common medical unmet needs:
- Lack of common biomarker identification strategies for clinically relevant and actionable genomic alterations in the various participating countries by the different analytical diagnostic laboratories: as every institution defines their own set of biomarkers, there is no common definition of what it should be tested. As such, it is difficult to compare treatment effectiveness and clinical outcomes;
- Lack of harmonized criteria of variant scoring and annotation, of harmonized variant interpretation (both pathologic and clinical interpretation), of harmonized methods and definition of TMB and of harmonized test result reporting; if no agreement exists between different institutions on how to analyse the observed variation in DNA sequences and report them, further analysis is strongly hampered, often quasi impossible;
- Lack of inter-operational data exchange protocols (ethical, legal and privacy constraints), and consequently of harmonized data registration, handling and processing; and,
- Lack of harmonized procedures for handling and storing of samples and molecular data in the biobanks.
These gaps hinder the establishment of a valuable common tumour profiling strategy allowing to provide equal access to innovative medicines to all. They hinder outcome research analysis after treatments with targeted therapies as diverse testing regimes lead to results that are difficult to interpret together. In this way, it is difficult to obtain large enough datasets to perform valid statistics analyses.
Thanks to the preliminary analysis of the state of the art (market analysis, current system in use in the Buyers Group and publications & patents searches), oncNGS consortium confirms that right now no existing technology would meet the needs identified by the buyers. Consequently, these needs are to be considered unmet and further research and development is necessary to get them addressed.
The oncNGS solution supports the deployment of innovative medicines through targeted broad-genome analysis at an affordable price in a standardized manner. Such approach will drastically lower the societal cost of the undoubtfully valuable innovation, smoothen the organization of surveillance and monitoring and guaranteeing sustainability of the healthcare system.
With respect to profiling the molecular changes invoked in tumorigenic materials in cancer patients, the Buyers Group face the current state of the art limits and common medical unmet needs:
- Lack of common biomarker identification strategies for clinically relevant and actionable genomic alterations in the various participating countries by the different analytical diagnostic laboratories: as every institution defines their own set of biomarkers, there is no common definition of what it should be tested. As such, it is difficult to compare treatment effectiveness and clinical outcomes;
- Lack of harmonized criteria of variant scoring and annotation, of harmonized variant interpretation (both pathologic and clinical interpretation), of harmonized methods and definition of TMB and of harmonized test result reporting; if no agreement exists between different institutions on how to analyse the observed variation in DNA sequences and report them, further analysis is strongly hampered, often quasi impossible;
- Lack of inter-operational data exchange protocols (ethical, legal and privacy constraints), and consequently of harmonized data registration, handling and processing; and,
- Lack of harmonized procedures for handling and storing of samples and molecular data in the biobanks.
These gaps hinder the establishment of a valuable common tumour profiling strategy allowing to provide equal access to innovative medicines to all. They hinder outcome research analysis after treatments with targeted therapies as diverse testing regimes lead to results that are difficult to interpret together. In this way, it is difficult to obtain large enough datasets to perform valid statistics analyses.
Thanks to the preliminary analysis of the state of the art (market analysis, current system in use in the Buyers Group and publications & patents searches), oncNGS consortium confirms that right now no existing technology would meet the needs identified by the buyers. Consequently, these needs are to be considered unmet and further research and development is necessary to get them addressed.
The oncNGS solution supports the deployment of innovative medicines through targeted broad-genome analysis at an affordable price in a standardized manner. Such approach will drastically lower the societal cost of the undoubtfully valuable innovation, smoothen the organization of surveillance and monitoring and guaranteeing sustainability of the healthcare system.