Codex4SMEs – Companion diagnostics expedited for SMEs

Project Acronym Codex4SMEs
Funding Program Interreg NWE
Budget 995,425
Coordinator BioRegio STERN Management GmbH
Website https://www.nweurope.eu/projects/project-search/codex4smes-companion-diagnostics-expedited-for-smes/
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.

Success story

Through Codex4SMEs, a collaboration with the Integrated Biobank of Luxemburg (IBBL) was set up that helped Metabrain Research develop high level quality procedures, support the development of validated SOPs and also the validation of its biomarker in human samples. Find out more here. 

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.