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PRECISION MEDICINE DEMANDS A MOLECULAR DEFINITION OF HEALTH AND DISEASE: THE PIVOTAL ROLE OF METROLOGY FOR SUSTAINABLE HEALTHCARE

PTB Kolloquium

In the pursuit of personalized patient management, biomarkers play a crucial role. Although genomic and transcriptomic analyses are of great value in the clinic, the complexity of the human body largely arises from variations in protein identities and quantities.

In basic research, mass spectrometry (MS)–based proteomics has greatly contributed to an understanding of cellular functions of proteins at a molecular level. Also large-scale exploratory efforts have been applied on retrospective studies of clinical cohorts in body fluids, searching for novel biomarkers. Yet, the number of new protein markers that made it from MS-based proteomics into the clinic is very limited. Rather than having a technological origin, key reasons for this translation lag are use of invalid samples, lack of appropriate study designs, silo thinking of the stakeholders involved, lack of appropriate test evaluation and lack of (timely) test standardization.

In clinical laboratories, proteins in body fluids are routinely tested for diagnostic and prognostic purposes as well as for therapy monitoring. It is, however, widely acknowledged that there is room for improvement with regard to sensitivity and specificity levels of current medical tests. Moreover, safe and disease-specific tests that support diagnoses at an early and curable stage are still lacking for a wide variety of diseases. Aiming and searching for better (protein) biomarkers starts by defining specific unmet clinical needs in current clinical care pathways. Interestingly, routinely used CE-marked immunoassays based on polyclonal antibodies generally measure mixtures of intact, degraded, complexed, post-translationally modified protein (PTMs) which may have different biological functions that go unrecognized. By design, conventional immunoassay-based tests ignore the clinical utility of specific proteoforms, variants or PTMs. Also test standardization is seriously hampered using immunoassays as the measurand intended to measure is not unequivocally defined at the molecular level.

Examples will be presented that demonstrate the pivotal role of metrology for precision medicine/ precision diagnostics through medical test standardization at the molecular level.  The latter is essential to generate proper evidence regarding the undisputed clinical value of medical tests. Establishing a joint strategic vision and a global network organization involving all stakeholders of the biomarker-to-medical-test development pipeline are key requirements for precision medicine in the nearby future.

 

„Mit Metrologie in die Zukunft – Herausforderungen bei Energie, Umwelt und Klima, Medizin, Quantentechnologie und Digitalisierung“

Die PTB will mit vereinten Kräften durch die Einrichtung von abteilungsübergreifenden Lenkungskreisen zur Bewältigung der großen Herausforderungen – Energie, Umwelt und Klima, Medizin, Quantentechnologie und Digitalisierung – beitragen und die Chancen nutzen. In der diesbezüglichen Vortragsreihe 2021 ff. sollen führende Köpfe der Wissenschaftslandschaft in die PTB eingeladen werden, um Synergien auszuloten und eine Übersicht zum Stand der Forschung zu schaffen.

Sie alle sind eingeladen, an diesen Vorträgen teilzuhaben und sich zu informieren – über den Stand der PTB sowie über die Entwicklung in Deutschland, Europa und weltweit.

Die Vorträge finden online oder hybrid statt und werden immer auch als Stream zur Verfügung gestellt sowie im Intra- und Internet angekündigt."

Links:
www.conf.dfn.de/stream/nr5or92wpowjw