Point-of-Care, Biosensors and Rapid Diagnostics Europe 2023 Agenda

Where are Things with the IVDR?
Erik Vollebregt, Partner, Axon Lawyers, Netherlands

The EU IVDR has completely shaken up the EU regulatory environment for market access and regulation of IVDs in Europe. It has been and continues to be plagued by bottlenecks, capacity issues and lack of essential elements for implementation (such as the Eudamed database, designation of reference labs and essential guidance). It has been amended to change the transitional regime early 2022. Where are things with the IVDR at this moment? This presentation will give an overview of the state of affairs of the EU IVDR at the moment and what things are crucial for IVD companies to take into account for a successful transition to the IVDR.

Rapid Point of Care Diagnostics – Microfluidic Sensors and Biosensors in the OR and NICU
Martyn Boutelle, Professor of Biomedical Sensors Engineering, Imperial College London, United Kingdom

The concentration of biomarker molecules can give important information about the health of a person as they are challenged by acute illness or for example surgery. Our view is that to do such monitoring effectively ideally requires moment-by-moment measurement of blood or tissue concentrations. We have been developing a range of sensing and biosensing solutions for the invasive, minimally invasive, and non-invasive monitoring of people in healthcare and training situations. Microfluidics provide a valuable means of clinical sampling and robust quantification of measured signals. I will describe the key challenges in the development of such integrated sensing devices present our recent data obtained during surgery and the neonatal intensive care unit.

Microfluidic Platforms for Diagnostics – From Idea to Production
Nils Paust, Head of Division Microfluidic Platforms, Hahn-Schickard-Gesellschaft für Angewandte Forschung eV, Germany

Several decades of microfluidic research and development are now behind us and I would like to share some strategies of commercialization that are used at Hahn-Schickard. We attempt to cover the complete value chain from idea to production. Microfluidic design, research labs equipped with biosafety, and rapid prototyping facilities are required for the first proof of concepts. However, in total, four manufacturing lines are needed to accompany the development from idea to production.  In a next step, we need to improve the level of confidence by scaling up production and test in clinical environments. For market entry, a certified production line should provide thousands of cartridges and eventually, fully automated high throughput manufacturing should provide cartridges for low prices. Simultaneously, a processing device must be developed, first as a measurement set-up, then as a functional model, and eventually as a product. In this talk, on the example of centrifugal microfluidic platforms, I will discuss applications and share our experiences on the different levels of microfluidic development.

Real-Time Continuous Biosensing Based on Single-Molecule Sensors
Menno Prins, Professor, Eindhoven University of Technology & Helia BioMonitoring, Netherlands

Single-molecule sensors collect statistics of single-molecule interactions in order to determine concentrations of analyte molecules. Single-molecule assays are generally end-point assays and are not designed for continuous biosensing. For real-time continuous biosensing, the single-molecule sensor needs to be reversible and should continuously report output signals with a well-defined time delay and precision. Here we describe a signal processing architecture and apply it to a sensor based on 10,000 individual particles that are tracked as a function of time. The continuous analysis includes particle identification, particle tracking, drift correction, and detection of timepoints where individual particles switch between bound and unbound states, yielding state transition statistics that relate to the analyte concentration in solution. We show the feasibility of real-time sensing and study how the precision and time delay of biomarker monitoring depend on the number of analyzed particles and on the size of the measurement time blocks. Finally, we discuss how the signal processing architecture can be applied to develop various single-molecule methods into continuous sensors.