Codex4SMEs – Companion diagnostics expedited for SMEs

Project Acronym Codex4SMEs
Funding Program Interreg NWE
Budget 995,425
Coordinator BioRegio STERN Management GmbH
Starting-ending date: May 24, 2021 - December 31, 2023

The Codex4SMEs project (initial project started in Sep 2017) addresses the main challenges faced by SMEs developing Companion diagnostics (Cdx): a time-and cost-intensive development process with a new, intense IVD-regulation effective in 2022. Codex4SMEs helped SMEs in North-West Europe to overcome these barriers by establishing a network that expedites the Cdx development process. This improves their innovative capabilities and competitiveness in the global Cdx market. 

Codex4SMEs will enlarge its established network by the involvement of 3 new partners from NL, DE and BE as a new NWE region, including EATRIS. The original support scheme for SMEs will be modified into a new Fast-Track Programme to further expedite the time-to-market of novel diagnostic solutions and to be applied for a broadened sector of diagnostics in general with a special focus on COVID-19 diagnostics. Thus, supported SMEs gain significance in international markets and increase their global competitiveness.

EATRIS role in the project  

EATRIS will offer tailor-made support services in various research aspects of the Dx product development within an newly established Fast-Track Programme, which include COVID-19 research services (access to biosample & bioreagents, testing of technology platforms and diagnostic assays, support for initiating clinical trials), prioritised to SMEs working in the field of COVID-19, but not exclusively. These services will consist of: partner search (matchmaking) to identify the best academic collaborator with the right scientific & medical expertise to answer to the specific need of a given SME, within the EATRIS network of more than 114 institutions; translational Assessment as service to assess the translational pathway and feasibility of projects according to various criteria: unmet medical need, IP, regulatory pathway etc and full regulatory assessment/scientific advice.