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TOPIC : Innovation Procurement: Next generation sequencing (NGS) for routine diagnosis

Topic identifier: SC1-BHC-10-2019
Publication date: 27 October 2017

Types of action: PCP Pre-Commercial Procurement
DeadlineModel:
Planned opening date:
single-stage
26 July 2018
Deadline: 16 April 2019 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Societal Challenges
Work Programme Year: H2020-2018-2020
Topic Description
Specific Challenge:

We observe a progressive shift in routine diagnostics, and more particularly in personalised medicine practice, from a growing number of molecular tests to a next generation sequencing approach (NGS). NGS can provide insights on a person’s genetic susceptibility to disease, diagnostic information, and predictive indications about treatment outcome. It also allows to embrace simultaneously different molecular pathways of disease evolution and to identify actionable mutations in a patient for medical decision and further research. In addition, it requires less sample material than multiple tests and therefore reduces risk and inconvenience for patients. However, the introduction of NGS in clinical practice is hampered by its cost, the availability of proper NGS tests, and diagnostic errors resulting from insufficient quality assurance, technological bias and complex interpretation of data.

Scope:

The objective is to implement NGS in routine diagnostics for personalised medicine and scale up demand-driven innovation for healthcare systems. This includes organisational, economical, technical and clinical aspects. It should lead to NGS tests, clinically validated procedures (including sex analysis), quality assurance schemes, tools and methods for data collection, management, analysis and interpretation, with a view to assist clinical decision-making and foster medical research and innovation. Transferability and cloud based NGS data analyses should be considered, as appropriate. Input from initiatives like the EJP Cofund on rare diseases and ERNs[1] should be considered when relevant. Ethical issues should be addressed.

For grants awarded under this topic for Pre-Commercial procurement it is expected that results could contribute to European or international standards. Therefore, the respective option of Article 28.2 of the Model Grant Agreement will be applied.

The Commission considers that proposals requesting a contribution from the EU of between EUR 9 and 11 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Proposals of this topic should follow the specific requirements for pre-commercial procurement PCP supported by Horizon 2020 grants as set out in General Annex E of the WP.

Expected Impact:
  • New NGS platforms and use of NGS tests in routine diagnostics for personalised medicine.
  • Accepted new European standards and quality assurance schemes with respect to NGS.
  • Strengthening of implementation of personalised medicine and improved clinical decisions and health outcomes for the benefits of patients.
  • Contribution to the sustainability of healthcare systems.
  • Growth and benefit to the European industry, in particular SMEs.
Cross-cutting Priorities:

Gender
Open Innovation
Innovation Procurement

[1]https://ec.europa.eu/health/ern/policy_en

Topic conditions and documents

1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.

2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.

Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.

3. Evaluation:

  • Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
  • Submission and evaluation processes are described in the Online Manual.

The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
The same applies to the second stage of the two-stage call for topics SC1-BHC15-2018, SC1-BHC01-2019, SC1-BHC02-2019, SC1-BHC14-2019, SC1-BHC19-2019, SC1-BHC22-2019, SC1-BHC25-2019

4. Indicative time for evaluation and grant agreements:

Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.

5. Proposal templates, evaluation forms and model grant agreements (MGA):

Pre-Commercial Procurement (PCP) Cofund:

Specific provisions and funding rate
Specific requirements for innovation procurement (PCP, PPI)
Standard proposal template
Standard evaluation form
MGA PCP/PPI - Multi-Beneficiary
Annotated Grant Agreement

Essential information for clinical studies

6. Additional provisions:

Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.

The funding rate for PCP actions is limited to 90% of the total eligible costs to leverage co-financing from the procurers in this specific case.

Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.

7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.

Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.

Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.

Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.

Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.

Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.

Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.

The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.

8. Additional documents:

Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020

Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme

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