Translational projects working on in-vitro-diagnostics often encounter similar challenges. These teams could be developing biomarkers or laboratory tests on a lab-scale, in a manner which is robust in their hands. Sometimes they are already running patient samples and have validated their approach and test systems in this way. Now, in order to further progress their translational program to place an IVD product on the market, different questions come into focus; The diagnostic test needs to fit in the clinical workup of the patients (patient unmet need) and bring an added value for the treatment, i.e. it has to have a therapeutic consequence, else it might not be a desirable diagnostic tool and thus not easy to place on the market. Moreover, the technical prerequisites that are necessary to run the test need to be present in a routine lab, so it is important to know the needs of the users and the general landscape of the stakeholders involved. In addition, teams have to understand the regulatory requirements for developing their IVD, including the CE-Marking and the quality-management setup necessary, and finally larger patient cohorts need to be validated.
In this Forum, Uwe Staub, IVD expert with 25years of experience from various positions in the IVD business, last as COO with Epigenomics, will share his experience with us. He will highlight what he has repeatedly encountered when meeting young startups on the IVD scene: the decision making of choosing the “lab service” or “IVD Kit” approach, and then dive into product development and associated regulations. We look forward to a great presentation and an interactive discussion.