Monday, 19 June 2023

For Logistics and Programming Details for Day 1 of the Conference Please Consult the Agenda for Lab-on-a-Chip and Microfluidics Track

Tuesday, 20 June 2023

For Logistics and Programming Details for Day 2 Morning, Please Consult the Organoids/Spheroids Track + the Circulating Biomarkers/Extracellular Vesicles Track

Session Title: Emerging Themes in Point-of-Care and Rapid Diagnostics

Venue: Conrad Room -- Hilton Rotterdam


Erik VollebregtKeynote Presentation

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.


REACH Restriction Proposal of Fluoropolymers and all PFAS-Substances: What is Happening in Brussels, How Will it Impact Microfluidics, Diagnostics and What to Do?
Wouter Geurts, Business Development Manager - FILMS , TEKNI-PLEX , Belgium

The purpose of the presentation is to provide a nutshell overview of what the current proposal is aiming at, what can be done (to respond to the open consultation by ECHA before it closes in September 2023 and to report uses of PFAS and fluoropolymers that are not yet listed, among them many which relate to microfluidics), and to present a roadmap on how this may impact the future of microfluidics – in essence – a roadmap.
What is happening now? While low-molecular PFAS are now being assessed by the Environmental Protection Agency in the USA, a much more significant legislative change is coming in Europe.
The REACH restriction proposal will ban over 10000 substances that contain Carbon-fluor bonds, and it will impact future use of materials used in diagnostic assay development and microfluidics in Europe, for instance because it will ban the use of PTFE. This will impact the future use of fluoropolymers and fluorinated substances in assays on a short term. The restriction is expected to enter into force in 2025-2026.



Martyn BoutelleKeynote Presentation

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.


Mid-Afternoon Coffee and Tea Break and Networking in the Exhiibt Hall


Optical Diagnostics for Bacterial Detection
Mark Bradley, Professor of Therapeutic Innovation, Precision Healthcare University Research Institute, Queen Mary University of London, United Kingdom

Over the past decade, we have designed and developed an entire palette of molecules containing targeting moieties (that specifically bind to Gram+ bacteria, Gram- bacteria and fungi) conjugated to a range of fluorophores to enable prompt and precise diagnosis of clinically relevant pathogens. I will describe these probes and explain how they have been used in a number of human systems including in vivo (in the human lung) and in eye and urinary tract infections. I will also describe a range of molecules that allow the binding and detection of bacterial infections and their subsequent elimination of infection following illumination.


Nils PaustKeynote Presentation

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.


Menno PrinsKeynote Presentation

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.


PKU-SMART-Sensor: An Integrated Point-of-Care System for the Self-Testing of Phenylalanine in Biological Specimen
Salvatore Petralia, Assistant professor, University of catania, Italy

PKU-SMART-Sensor is an an integrated Point-of-Care system composed by a miniaturized and low-cost biosensor, a reader for thermal processes and optical reading, wirelessly connected with a smartphone for the remote control and data acquisition. The biosensor integrates all the processes required for the Phe monitoring as: [1] sample treatments, [2] enzymatic recognition based on Phenylalaninedehydrogenase/NAD+-dependent and [3] colorimetric-transduction process based on the in-situ formation of plasmonic gold nanostructures.


(i)SIMPLE – Only One Finger Press Away From Enabling Decentralized Healthcare
Francesco Dal Dosso, Innovation Manager, KU Leuven, Italy

We present a novel self-powered microfluidic technology, named (i)SIMPLE, capable of unparalleled complex liquid manipulations in a user-friendly manner (single user activation step). (i)SIMPLE has been exploited as a [1] self-sampling and processing cartridge for remote collection of biofluids, [2] companion diagnostic chip for personalized therapeutic drug monitoring and [3] all-in-one device for POC (molecular) diagnosis of infectious diseases. The devices are low-cost and compatible with high throughput manufacturing, ready for industrialization.


Close of Day 2 Conference Programming