Public procurement notice: Prior Information Notice Without Call For Competition
Published: 2021-03-05
Buyer: Sciensano
Country: BE
Contract type: Services
CPV classification: 33100000 | 38000000 | 48180000 | 71900000 | 72100000
Estimated value: 7073554 EUR

Technical requirements: This pre-commercial procurement (PCP) is carried out by Scienciano who was appointed as lead procurer to coordinate and lead the joint procurement in the name and on behalf of the buyers group listed.
Pre-commercial Procurement to Buy R&D (Research and Development) Services for the Development of an Affordable Integrated Solution for Predictive, Prognostic and Diagnostic Analysis in Liquid Biopsies
This prior information notice (PIN) provides early information about the expected starting date and purchase volume for a pre-commercial procurement (PCP) and about the open market consultation that is organized in preparation of this procurement. More information about the open market consultation is provided in section II.2.14).
This procurement aims to trigger new solutions to be developed and tested to address the following challenge: successful implementation in routine clinical care practice of large ‘cellular free DNA’ molecular diagnostics based on NGS technology by means of a provision an integrated, cost-effectient and standardized sequencing and analytical data interpretation and reporting system in various oncology care settings in the EU.
Testing is expected to take place in Brussels (BE); Paris, Lyon (FR); Berlin, Munich (GER);, Barcelona (SP), Milan, Rome (IT)
(unmet need 1) Establishment of valuable common tumour profiling strategy allowing to provide equal access to innovative medicines to all;
(unmet need 2) Outcome research analysis after treatments with targeted therapies as diverse testing leads to lowering the pooling capacity of obtained results, needed to obtain large enough sample numbers to perform statistics analyses;
(unmet need 3) Application of such essential testing to all patients, breaking down current unacceptable inequities due to the high costs of current diagnostics tests.
Through the provision of an (solution 1) efficient molecular DNA/RNA profiling of tumour-derived material in liquid biopsies by means of (solution 2) pan-cancer tumour marker analysis kit including NGS analysis integrated with (solution 3) an on-site ICT decision support system including analytical test interpretation and reporting.
The procurement will take the form of a pre-commercial procurement (PCP) under which R&D service contracts will be awarded to a number of R&D providers in parallel in a phased approach. This will make it possible to compare competing alternative solutions.
Phase 1 suppliers will design their solution based on their background and their analysis of the technology strategy, technical feasibility, quality plan, risks assessment, business model, financial feasibility, ethics and data protection management done to satisfy oncNGS requirements. During Phase 1, suppliers will be requested to deliver the Analytical test plan they will perform in Phase 2.
This phase will require from the suppliers concise research and development to match any of their in-house tools to the needs of the buyers group. In silico/in vitro primer assessments, bioinformatics software adaptations, algorithm adaptation and form development will have to be taken up. At the end of the Phase 1, the invitation to Phase 2 (call-off) will be issued.
Phase 2 suppliers will develop their solution and demonstrate their analytical validity having followed the Analytical test plan approved in Phase 1. The Analytical validation will consist of demonstration of assay performance (accuracy, precision, specificity, etc.). During Phase 2, suppliers will be requested to deliver the clinical validation protocol of the pre-commercial devices and Data Management Plan (‘DMP’) (including patients’ consents) they will perform in Phase 3.
This phase will require from the suppliers further research and development to optimize the in silico/in vitro defined primer combinations, the bioinformatics pipeline and interpretation and reporting algorithms when aiming to meet the criteria of analytic validation on sample DNA materials (sensitivity, specificity, transferability, robustness, etc). At the end of the Phase 2, the invitation to Phase 3 (call-off) will be issued.
Phase 3 suppliers will validate their approved analytical solution on the oncNGS and demonstrate the clinical validity of the solution following the protocol approved in Phase 2 and authorized by the relevant ethical committees and all the other authorizing entities/agencies.


Award value: 7073554