Diagnostics - development and market uptake in the spotlight

On April 21, 2022, the online seminar From Research & Product Development to Market Uptake within the Diagnostics Sector took place as part of the Interreg NWE Codex4SMEs project. Diagnostics developers from a wide range of SMEs across Europe were presented an overview of fundamental aspects of protecting and funding their inventions, as well as regulatory requirements of the IVDR for the market uptake of diagnostics in the EU.

Emanuela Oldoni, Scientific Programme Manager at EATRIS and partner in the Codex4SMEs project, kicked off the event by presenting the Codex4SMEs SME Support Programme. This so-called Fast-Track Programme covers the cost of various services, such as biomarker validation, regulatory and translational assessment of diagnostics, access to patient samples or large Pharma or MedTech companies for potential collaborations. Furthermore, SMEs can benefit from tailored workshops addressing various topics such as regulation, financing, patenting, market access, or reimbursement.

In a talk by René J. Raggers, European patent attorney (Life Sciences, Food, Medical, Biotech) at AOMB Intellectual Property, participants learned how diagnostics manufacturers can best protect their inventions as intellectual property. He addressed the question of whether patents are really necessary, considering that the process of patenting is expensive and time-consuming and requires individual applications to be filed in different countries, for example in the USA, Japan, China or at the European Patent Office. Especially for new diagnostics it seems to be necessary to patent them in the long term, as the development costs are extremely high. But is it worth the effort to apply for a patent at all? A comparison of EPO and USPTO based on a biomarker showed the possibilities and limits for filing a patent.

A key issue, especially for young diagnostics companies, is financing the development of new biomarkers. Wim Van Criekinge, professor at Novalis addressed in the first point why despite mountains of publications on new markers, only a small number of markers find their way into clinical practice. With the advice to "begin with the end in mind," attendees were reminded that their tests are measured against gold standards. For clinical applications, both the specificity and sensitivity of a test are relevant. Meaning, very specific tests yield few false positive results. Thus, with a positive result, one can be sure that the patient has the disease. A negative result on a very sensitive test indicates that the patient does not have the disease. The prevalence of a disease and predictive values should also be considered at the start of development. To illustrate the efficient procedure to develop a commercially viable test, an example on specimen collection to diagnose prostate cancer was used.

The omnipresent topic of IVDR, which is currently a major challenge for most diagnostics manufacturers, was summarized in a short and concise presentation by Greer Deal Director at Med-Di-Dia Limited. The three central points - regulatory and quality compliance strategy, the impact of changing regulatory requirements for IVD companies, and the importance of your quality management system (QMS) - were addressed step-by-step. Especially for SMEs, the implementation of the IVDR is a major hurdle. Therefore, SMEs with company headquarters in the North-West European region can apply for a workshop offered by Med-Di-Dia at the end of May 2022. More information coming soon.