Diagnostics for predicting and preventing diseases and for personalised treatment are needed to offer patients tailored, targeted solutions with fewer side-effects. It takes a great deal of time and money to develop the relevant methods and devices, but they are regarded as the key to fundamentally improving healthcare. The goal of the Codex4SMEs project was to foster the development of these diagnostics and of personalised medicine as a whole. With this in mind, the project partners from eight different countries (Belgium, Germany, Ireland, the UK, France, the Netherlands, Luxembourg and Austria) established a network made up of stakeholders from industry (such as SMEs and large pharmaceutical and medtech firms) and research, along with other service providers specialising in regulatory matters and market access. That made it possible to create new incentives for industry and speed up the growth of this diagnostics market.

The network specifically provided SMEs with support in developing solutions for personalised medicine. They received exclusive access to cost-intensive services and expertise that they would not have been able to finance on their own. The project had a budget totalling EUR 4.18 million. This included vouchers redeemed for biomarker validation, international regulatory assessments and consultancy services, worth up to EUR 100,000 for individual companies. Amongst other things, SMEs benefited from the availability of patients’ samples, help with translational feasibility and the regulatory requirements for their new diagnostics, access to big pharma and medtech companies, and workshops focusing on the market launch of medical devices and in vitro diagnostics. This support could be called upon during various phases of the product lifecycle – development, preclinical and clinical research, and market entry.

To make this possible, the project drew on the proven international expertise of the twelve partners – the Integrated BioBank of Luxembourg, Biobank Graz at the Medical University of Graz in Austria, technological development agency BOM Holding BV (Brabantse Ontwikkelings Maatschappij), InnovationQuarter and the European Research Infrastructure for Translational Medicine in the Netherlands, flanders.bio in Belgium, WestBIC (EU Business and Innovation Centre for Ireland’s Border, Midlands and Western Region) and CÚRAM (Science Foundation Ireland Centre for Research in Medical Devices at NUI Galway) in Ireland, the University of Leicester and its regional subpartner Medilink Midlands in the UK, Medicen Paris Region in France, and lead partner BioRegio STERN and Health Innovation Hub Holding GmbH in Germany.

“During this project, an excellent partnership developed that will definitely have a long-term impact. The Codex4SMEs consortium and the associated diagnostics ecosystems have formed a dependable, trusting and supportive long-term partnership,” stated project manager Dr. Margot Jehle from BioRegio STERN Management GmbH at the joint closing event in Stuttgart in October 2023. “And the companies have confirmed to us that they received exactly the support they needed to take their business and/or their products to the next level,” she added.

Over the course of the six-year project, over 420 organisations from a total of 30 countries took part in the programme, benefiting from tailored services and events. More than 90 SMEs received targeted support for the launch of new products, and over 45 R&D collaborations were initiated with biobanks, university hospitals and enterprises.

Solios Diagnostics GmbH from Tübingen in Germany was amongst the Codex4SMEs programme participants. It has developed a compact system that makes rapid tests for pathogens or biomarkers simpler and more reliable. During the closing conference, Solios Managing Director Dr. Tina Hassberg provided a detailed account of the advantages resulting from her company’s participation in the Codex4SMEs programme: “The Codex4SMEs research service helped us prove that our device works.” Dr. Hassberg also emphasised that the Meet&Match.Dx programme had been a great help to her start-up: “For us, it was a big step in the direction of an important industrial partnership. We also received useful feedback from manufacturers about our device and gained vital insights into specific customer requirements.”

A large number of companies were equally enthusiastic, underlining the quality of programme offerings such as Meet&Match.Dx and pitch presentation training. Many SMEs considered it hugely important to be part of an active European network with specialists from the various partner regions, and even beyond. The participants ultimately agreed that the success stories of the Codex4SMEs project must be continued so that patients can benefit from innovative diagnostics and personalised medicine reaching the healthcare market faster and more cost-effectively.