The IVDr Platform Concept and Enabling Tools. M.Spraul, H.Schäfer, C.Cannet, F.Fang Bruker BioSpin Biobank Webinar 2018

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1 The IVDr Platform Concept and Enabling Tools M.Spraul, H.Schäfer, C.Cannet, F.Fang Bruker BioSpin Biobank Webinar 2018

2 2 Ready to integrate LC-MS/MRMS into a Metabolic Profiler The IVDr Concept IVDr= In Vitro Diagnostic Research IVDr: Offering a completely standardized push button concept based on the IVDr Platform and its embedded solutions for Clinical and Translational Research allowing: - integration of results from different user groups all over the world, forming a sofar unthinkable reservoir of completely compatible spectral data and analysis results - Speed up translation to future diagnostic methods, be it for personalized medicine or populationwide studies on phenotypes and associated risk factors. - Development of future diagnostic routines with unmatched specificity and sensitivity - Enabling tools for quantification of a large number of compounds

3 The World of standardized Metabolomics NMR (SOP and fieldstrength) for the IVDr multi-solution platform allowing worldwide interdisciplinary exchange Pharma Metabolite ID Foodomics Food Industry Phenome Centers Pharma Toxicity Screening Clinical Phenome Centers Pharma Dose/response optimization Biobank Qality control Human Metab Research Universities Clinical Service Providers Environment and human health Forensic Departments Hospitals, Large medical practises 3

4 IVDr-Platform and Standardization : Allows to combine solutions, developed by Bruker BioSpin and/or external partners External Partner 1 Cardiovascular Diseases In progress External Partner 2 Prostate Cancer in progress External Partner 3 Obesity/Diabetes Metabolic Syndrome In progress External developments in R&D Ecosystem The IVDr Platform concept IVDr-Platform+Tools 4

5 Operation based on complete standardization guarantees unrestricted exchangeability of data worldwide FoodScreener 5 Data Analysis e.g. Addressing CVD risk worldwide Note: Epidemiological spectral databases only make sense, when data implemented are run identically (SOPs) Currently > 60 groups worldwide operate under Bruker NMR SOPs

Enabling Tools on the IVDr Platform for automatic analysis in Plasma/Serum B.I.LISA and B.I.QUANT-PS Fast version ~8 min One 1D-experiment B.I.LISA and B.I.QUANT-PS Standard version ~ 18 min 2*1D-experiments + 2D-J-Resolved B.

6 Enabling Tools on the IVDr Platform for automatic analysis in Plasma/Serum B.I.LISA and B.I.QUANT-PS Fast version ~8 min One 1D-experiment B.I.LISA and B.I.QUANT-PS Standard version ~ 18 min 2*1D-experiments + 2D-J-Resolved B.I.BiobankTool (QC) B.I.QUANT-PS B.I.LISA Complete Package IVDr-Methods SOPs for plasma and serum 6

7 Improve your value proposition: Add B.I.QUANT-PS for every Plasma/Serum sample (Bruker IVDr Quantification in Plasma/Serum) Allows content stacking with Urine Quantification Biobanks Epidemiology Output of B.I.QUANT-PS consists of 26 parameters listing the concentrations for Plasma/Serum in detail. Food related changes in Plasma/Serum Composition show influence on health Frequent health problems like cardiovascular diseases, diabetes and cancer Such analysis supports research and produces invaluable input in: Ability to monitor and optimize treatment Information about personalized profile in plasma/serum B.I.LISA TM

8 Small molecule Quantification in Plasma/Serum B.I.QUANT-PS 26 small molecules quantified From same measurement as B.I.LISA (lipoprotein subclass analysis) 2 Viewpoints into disease! Validated by DIN ISO Spiking Retrospective analysis 8

9 Plasma/Serum Quantification in detail Example Creatinine 95% range In model set Actual Sample Outlier in Pyruvic Acid 9

10 1 0 Metabolite recognition and quantification under full automation Push button automation From measurement to final report. Shown are examples for the automatic Fit

11 TMAO quantification in plasma/serum Trimethylamine-N-oxide (TMAO) produced by gut microbiota metabolism of dietary choline and carnitine has been shown to be associated with increased risk of cardiovascular disease (CVD) and to provide incremental clinical prognostic utility beyond traditional risk factors for assessing a patient's CVD risk. Clin Biochem Nov;50(16-17): doi: /j.clinbiochem Epub 2017 Jun 15. increased fasting serum TMAO levels associate with increased cimt (carotid intima-media thickness), independently of established cardiovascular risk markers, including insulin resistance, visceral obesity and fatty liver. Furthermore, the decrease of cimt during a lifestyle intervention appears to be related to the decrease of TMAO levels. Sci. Rep. 6, 26745; doi: /srep26745 (2016) 11

12 Lipoprotein Subclass Analysis B.I.LISA TM in health/disease related research Stroke Diabetes type 2, obesity, metabolic syndrome Food/environment and health High blood pressure Fatty Liver disease Thrombosis B.I.LISA supports research and produces invaluable input in: Alzheimer (APO-A1 binds Amyloids) Atherosclerosis Cerebrovascular Diseases General Cardiovascular diseases ( in prevention, early detection and treatment) Inflammatory Diseases Cancer (e.g. via blood triglycerides) 12 B.I.LISA TM

13 Automatic report Lipoprotein Subclass Analysis Plasma/Serum (RUO only) 114 parameters in one experiment 13

14 14 Recognize cardiovascular risks in time to prevent incidents Control sample Donor had cardiovascular event 3 days after blood collection

15 Longitudinal NMR Reproducibility ringtest on 11 IVDr platforms in 5 organizations on lipoprotein analysis NCEP Criteria for Lipid and Lipoprotein Testing Instrument specific variance in QC samples 15 Innovation with Integrity

16 Improve your value proposition: Add B.I.QUANT-UR TM for every urine sample Bruker IVDr Quantification in urine. Can be combined with B.I.LISA TM on the same platform Biobanks Epidemiology Frequent health problems like in diabetes, metabolic syndrom, kidney and cancer The output of B.I.QUANT- UR TM consists of up to 150 parameters describing the metabolite composition in urine in detail. Such analysis supports research and produces invaluable input in: Food related changes in urine metabolite Composition show influence on health Ability to monitor and optimize treatment Information about personalized profile in urine B.I.Quant-UR TM

17 Urine Quantification B.I.QUANT-UR TM Report Excerpts basic 50 Metabolites Most often found : extended 150 metabolites Basic + Disease markers : Also available Neonate Extended 150 metabolites 2 age ranges Better accuracy Fully automatic Based on B.I.Methods Report is ready Few minutes after Measurement (PDF or XML) Exceeds ISO Requirements Wet and numerical Spiking done on all metabolites for LOD estimation concentration Ranges given 17 B.I.Quant-UR TM

18 Biobanks and NMR QC process Generates NMR Data for storage in the biobank Extensive QC of Incoming samples Add Analysis Results to spectra And metadata: e.g. Urine Quant. Lipoprotein Subclass Analysis 18 Sort out Aliquots with Low quality NMR for Biobanks Gain new funding possibilities NMR can provide added value to biobanks: Offer metadata Selected spectra from inventory Support development Of new diagnostic routines Build compatible Spectra base with Phenome centers Build compatible spectra inventory To other biobanks ww Support Clinical trials with spectra instead of aliquots to measure

19 Biobank Workflow B.I.Methods Spectrum B.I.BioBankTool QC results B.I.Methods B.I. BioBank Tool

Matrix Identity Test Matrix Integrity Test Matrix ContaminationTest NMR preparation NMR

20 Biobank QC in Plasma/Serum and Urine Criteria Plasma/Serum Matrix Identity Test Matrix Integrity Test Matrix Contamination Test NMR preparation NMR measurement Criteria Urine Matrix Identity Test Matrix Integrity Test Matrix ContaminationTest NMR preparation NMR measurement Medication Test Protein Background Test Test for further indicative parameters

21 Thank you M.Nauck et al Greifswald University Hospital F.Trefz, J.Okun, G.Hofmann Heidelberg Hospital Pediatrics J.Nicholson, J.Lindon, E.Holmes Imperial College London A.Deelder, A.Meissner LUMC Leiden C.Luchinat et al CERM Florence Italy T.Bathen NMR Centre Trondheim 21

Clinical Metabolomics by 1. H-NMR Spectroscopy

Clinical Metabolomics by 1. H-NMR Spectroscopy Clinical Metabolomics by 1 H-NMR Spectroscopy Prof. Dr. Matthias Nauck Institute of Clinical Chemistry and Laboratory Medcine University Medicine Greifswald matthias.nauck@uni-greifswald.de Transparency