To mark the conclusion of the Codex4SMEs project, partners from six countries met in Stuttgart at the premises of the German lead partner, BioRegio STERN Management GmbH. For a total of six years, they supported the creation of a transnational network as part of the European Interreg North-West Europe (NWE) project. The aim was to expedite the development of innovative diagnostics – above all for personalised medicine – along the entire value chain of small and medium-sized enterprises (SMEs). The impressive results were presented in October 2023. Over 420 companies from 30 different countries took part in the programme. Thanks to Codex4SMEs, patients will benefit from faster and more cost-effective diagnostics in the future, including what are known as “companion diagnostics”. Read More
On September 12, 2023 the Personalized Medicine Coalition, Interreg NWE Codex4SMEs and European Infrastructure for Translational Medicine hosted a virtual tutorial on the regulatory pathways for bringing new diagnostics to market in the United States and Europe. More than 100 diagnostics industry executives and employees attended the event to get insights in the efficient regulatory review of a new generation of innovative diagnostics that promise to advance the frontiers of personalized medicine to benefit patients and health systems. Read More
In February 2023 we launched the second edition of the Meet&Match.Dx as part of Interreg NWE Codex4SMEs, a challenge-based acceleration programme connecting SMEs producing ground-breaking diagnostic solutions to leading European MedTech corporations. Read More
Are you interested in collaborating with leading MedTech companies to tackle diagnostic challenges and open the path for partnership exploration? Join the Meet & Match.Dx, a challenge-based acceleration programme that connects SMEs developing breakthrough diagnostic solutions with major pharmaceutical and medical technology companies in Europe through tailored workshops and one-to-one pitch sessions, with the aim to explore partnership opportunities. Read More
We are glad to announce today that 16 companies have been selected to participate in the programme and explore partnership opportunities with Medtronic, Abbott, GSK and ThermoFisher Scientific. Read More
Companion diagnostics (CDx) must be evaluated by notified bodies since the IVDR comes into force in May 2022. A recent study assessed how the EMA addressed new CDx in 2017-2019 in dossiers for marketing authorization procedures and 2016-2020 in scientific advisory procedures before the implementation of the new IVDR. The analysis reveals that CDx played a role in the evaluation of 20 of 167 medicines approved or rejected by the EMA. Using both the European public assessment reports (EPARs) and the internal assessment reports (ARs) from the EMA's centralized approval process, the authors showed that clinical performance and analytical performance of CDx were the most frequently discussed topics. The experience from the previous assessment processes, may serve as a guide when EMA and EU Member State national agencies are formally consulted by notified bodies on CDx performance and safety. Read More
Sophie Raynal (Metabrain Research SA, France) presented the entrepreneurial perspective on translation in practice – developing and bringing a PM product to the market. Read More
We are pleased to announce that our network expert for regulation in medical technology and in vitro diagnostics Med-Di-Dia is celebrating its 3rd anniversary. Read More
Are you interested in collaborating with leading MedTech companies to tackle diagnostic challenges and open the path for partnership exploration? Join the Meet & Match.Dx, a challenge-based acceleration programme that connects SMEs developing breakthrough diagnostic solutions with major pharmaceutical and medical technology companies in Europe through tailored workshops and one-to-one pitch sessions, with the aim to explore partnership opportunities. Read More
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