Medica Labmed Forum Presents Innovations from the World of Laboratory Medicine

Since 2017, the field of laboratory medicine has been represented by a scientific event of high-caliber experts at internationally leading trade fair MEDICA (Düsseldorf, Germany). The event takes place in the trade fair area featuring laboratory equipment and diagnostics, where several hundred exhibitors participate each year. In spite of, or maybe especially because of the COVID-19 pandemic, the MEDICA LABMED FORUM has been enjoying growing recognition within both academia and the industry. During MEDICA 2022 (14 – 17 November), the newest scientific findings from across the broad spectrum of diagnostic medicine will be presented again in Hall 1. As part of the program by the specialist forum for laboratory medicine, renowned experts will be holding highly up-to-date lectures here on stage.

After having taken place on a completely digital platform due to the pandemic in 2020, the MEDICA LABMED FORUM returned last year as an in-person meeting-point for international guests. The two scientific organizers, Prof. Dr. Georg Hoffmann and Prof. Dr. Stefan Holdenrieder, both laboratory doctors at the institute for laboratory medicine at the German Heart Centre of the Technical University of Munich, have put together a total of eight sessions for this year and created an inviting, multi-faceted program about notable trends within in-vitro diagnostics (IVD). The motto of the opening day will be "Regulations and quality ". The second day of the event is dedicated to short lectures and interactive stage discussions about the newest trends in laboratory medicine. On 16 November, recently discovered biomarkers take central stage. The closing day on 17 November will showcase innovative developments within the life sciences.

Day 1: Regulations and quality

The event is opened on 14 November by a session organized by Prof. Dr. Astrid Petersmann, Medicine and Health Sciences at Oldenburg University, on the current challenges posed by regulations within laboratory medicine. This day of the forum is dedicated in particular to the European In-vitro Diagnostics Medical Devices Regulation (IVDR), which aims to markedly improve the standards of quality within the area of diagnostics to increase patient safety. As of May 2022, these regulations now apply to laboratory diagnostics as well and pose enormous regulatory challenges not only to manufacturers, but also to medical laboratories using proprietary assays – for example for specialized parameters – in practical patient care. "A statement such as ‘We've always been doing it like this’ will be unacceptable in the future,” says Prof. Petersmann.

In the same sense, this applies to quality assurance methods which have been established for many years, but the requirements of which have so far been formulated more from a perspective of technical feasibility than from a perspective of medical necessity. This is to change in the future, and Prof. Dr. Matthias Nauck, Greifswald University Department of Medicine, will present the first steps that have been established. For example, the analytical requirements for the parameters for diagnosis and treatment of diabetes mellitus were already substantially increased for the benefit of patients. This approach will also be the foundation for further development of the guidelines issued by the German Medical Association. Other than that, information about the quality of the examinations carried out by medical laboratories must become more transparent and concrete for the attending doctors. This aspect will be discussed in the part of the event titled "Quality assurance in patient-oriented laboratory medicine". The session leader is certain that her referents will present and discuss a number of important innovations in the auditorium.

Day 2: Trends in laboratory medicine

Referred to as liquid biopsy or liquid profiling, diagnosis through nucleic acids circulating in the blood (CNAPS) has been talked about now for years. According to Prof. Dr. Stefan Holdenrieder, who will lead the session on "New insights in circulating nucleic acid diagnostics" on 15 November, this diagnostic technique is quickly taking the leap from a scientific research method to clinical practice – from "bench to bedside". While already standard in non-invasive pre-natal tests, there are now large studies available on its use in tumor patients, including the selection and monitoring of targeted therapies, detection of minimal residual disease and early diagnosis of multiple types of tumors. CNAPS diagnostics are also coming into focus for the detection and classification of sepsis, as well as in monitoring after transplantation. One important reason for this progress in development, other than the availability of sensitive high-throughput technologies, is a deeper understanding of the biology, structure and function of nucleic acids in the blood. For example, epigenetic and fragmentation patterns of DNA are being increasingly used not only to detect disease, but to trace the origin of the tissue. Dr. Abel Bronkhorst from the Technical University of Munich will offer an introduction to the newest discoveries within the basic science of circulating nucleic acids, the varied uses of which for clinical diagnostics will be then presented and discussed by proven experts.

The "perpetual issue" of COVID-19 will again have its own session this year, titled "COVID-19: The challenge remains". Current challenges include the ongoing, astounding evolution of perpetually new virus variants and the resulting necessity for adapting diagnostics, therapy and the development of vaccines accordingly. Therefore, the first presentations will focus on detecting new virus variants, on immune response assays using antibodies and t-cell tests, and on approaches to developing a universal COVID-19 vaccine. As another challenge both for individuals and for society as a whole, long-COVID syndrome is also slowly beginning to gain attention. To better understand and treat this slowly spreading "disease after the disease" which affects millions of people worldwide – including those who had a mild course of acute illness – and which can cause long-lasting physical and psychological disability, a deeper understanding of the pathophysiology, new molecular diagnostic tests and specialized treatment centers for affected patients are necessary. Prof. Dr. Uta Behrends of the Chronisches Fatigue Centrum für junge Menschen (MCFC), the centre for chronic fatigue for young people at the Technical University of Munich, already has many years of experience with fatigue syndromes following various viral diseases. She will report on her work with an interdisciplinary team of specialists caring for children and adolescents with long COVID and ME/CFS.

Day 3: Rising stars: Emerging biomarkers in laboratory medicine

The two last days of the forum will take a look at the future of laboratory medicine and the life sciences. On 16 November, Dr. Verena Haselmann from the University Hospital Mannheim and a team of young, dedicated scientists will shine a light on the "rising stars" among the new biomarkers on the scientific stage. What is new and which methods are on the way to becoming standard care – both of these questions will be the focus of lectures and discussions.

The morning will be dedicated to technologies the potential of which for medical diagnostics and therapy is still under evaluation. This includes new methods of sequencing genomes and detecting complex epigenomic changes. Another topic is the application of these methods on single cells (single-cell omics) and the examination of blood samples by magnetic resonance imaging (MRI); a method which so far has only been routinely used for diagnostic imaging. All these methods have in common that their analysis produces immense volumes of data. Their evaluation poses the real challenge here. During the morning session, Prof. Dr. Jonathan Schmid-Burgk of the Institute for Clinical Chemistry and Clinical Pharmacology of the University Hospital Bonn will provide an introduction to high-throughput sequencing and novel applications in his lecture “Next-generation sequencing – what´s new?” There will also be a discussion on the benefits of functional genetic mapping of hotspot genes.

In the afternoon, on the forum event stage in Düsseldorf, there will be an introduction of methods which are already closer to being ready for the market, but still subject to heavy discussion. This is where, for example, we will hear about detecting genetic aberrations of the embryo in the maternal blood (NIPT) or immune response assays on the cellular level, which are of importance right now when assessing the status of immunity during the COVID-19 pandemic. In his lecture "LDTs in the light of the IVDR – still an option for standard care?", Dr. Maximilian Kittel of the Institute for Clinical Chemistry at the University Medical Centre and Medical Faculty Mannheim of Heidelberg University will ask the critical question whether and under which conditions lab-developed testing procedures will still be usable for routine diagnostics once the new IVD guidelines are wholly in place. Here one focus lies on the conflict inherent between personalized medicine and hospital performance records. The day will end with contributions to the evaluation of data through expert systems and proprietary laboratory developments (LDT = lab-developed tests), which need to pass the new IVDR regulations in order to become routine procedures.

Day 4: Innovative developments in the life sciences

On 17 November, Dr. Peter Quick, head of the Life Science Research work group at VDGH e.V., the German association of the diagnostics industry, will bring researchers and developers on stage whose work on RNA technologies, highly important for the development of vaccines, has gained widespread recognition.

Dr. Christian Dohmen, Ethris GmbH, Senior Director Formulation & Aerosol Research, will present the mRNA Therapeutics for Lung Diseases project, one of the RNA technologies discussed. The project advocates for a novel class of mRNA products to be used as therapeutics in the treatment of respiratory and infectious diseases. The Ethris technology platform will pave the way for a protein replacement therapy for rare lung diseases and for antiviral therapies.

In her lecture, Dr. Janine Altmüller, MDC for molecular medicine and head of the Genomics Core Berlin Institute of Health at the Charité, will look beyond to even more advanced, revolutionary research technologies in life sciences: single-cell and spatial omics. As all living processes in organs and organisms rely on the functions of their basic building blocks, single cells and their interactions, these methods are of immense value for research into the physiology of health and disease. Dr. Altmüller will offer a broad introduction of technological concepts for single-cell and spatial analysis, present advantages and limitations, and illustrate their effects by presenting several highly impressive case studies.

Gene therapy, genome editing and diagnostics – where does the journey lead? Toni Cathomen, professor for cell and gene therapy at Freiburg University and director of the Institute for Transfusion Medicine and Gene Therapy at the University Medical Center, will also take a look at the future. Programmable nucleases like CRISPR-Cas have hailed a new era within personalized medicine. Prof. Cathomen will explain the principles of gene therapy and genome editing, present examples of successfully applied gene therapies for diseases of the blood and the immune system, and discuss new technologies for editing the genome, which have noticeably enlarged the application spectrum of gene therapy. He will end his presentation with a closer look at diagnostic assays used to assess, and where appropriate ameliorate, the risks of genotoxicity. The audience is invited to share his vision of the future of this field.

Though the topics are complex, it is a hallmark of the four-day event that all presentations are short, precise and easy to understand, and that rewarding discussions with the audience can be held on stage. This concept has contributed significantly to the success of the MEDICA LABMED FORUM as one of the highlights of the program at MEDICA.

MEDICA DEEP DIVE: Diagnostics of infectious diseases

And for all those who would like a "warm-up" in the sense of a more in-depth preparation for their visit to MEDICA, the digital, English-language talk rounds "MEDICA DEEP DIVE" are ideal. They will start shortly and focus on particularly relevant trend topics in the healthcare sector. They will start on 22 September with a topic from the field of laboratory medicine: "Diagnostics of infectious diseases" with a focus on current innovations and developments in the field of point-of-care diagnostics.

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