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project info
Start date: 20 September 2017
End date: 31 December 2023
funding
Fund: European Regional Development Fund (ERDF)
Total budget: 4 314 264,53 €
EU contribution: 2 588 558,72 € (60%)
programme
Programming period: 2014-2020
Managing authority: Région Hauts-de-France
intervention field
n/a

Companion Diagnostics expedited for SMEs

All healthcare providers aim to deliver improved patient outcomes. The Codex4SMEs (Companion diagnostics expedited for SMEs) project plans to improve healthcare by enhanced adoption of Personalized Medicine (PM) in NWE and beyond. PM promises to deliver “the right drug, at the right dose, at the right time, to the right patient” with important cost-savings in public healthcare. Companion diagnostics (Cdx) are an indispensable tool for optimum application of PM, but currently only few therapies (1% in DE) are accompanied by Cdx tests. A strong growth of the global PM market will also drive growth of the Cdx market. NWE SMEs, as diagnostics innovation drivers, have a strong potential to exploit this market. However, NWE is not competitive with the USA in the implementation of Cdx. Reasons are: - EU regulation not yet established (new IVD Directive becomes effective in 2020), - High development costs (> € 5 m), - Project length (> 5 years). The USA are far ahead of NWE in creating a commercially attractive regulatory & market structure. Codex4SMEs will establish a network of 11 partners from seven countries (DE, FR, NL, UK, IE, LU and AT as non-NWE participant). The project will support SMEs along the Cdx value chain in the three phases incubation, acceleration and growth. Partners aim to involve around 200 SMEs in the field of Cdx into the project. 46 of those will have increased the TRL levels of their Cdx products at least 1 level through the support in knowledge transfer/sample access and biomarker validation. At least four SMEs will finish the development of a new product already during the project duration thanks to Codex4SMEs. Finally, the long term sustainability of the network and the support services for SMEs beyond the project will be ensured by collection of at least 100 letters of intent from future members/sponsors.

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