BIOMARKER VALIDATION Targeted Assays Delivering Absolute Quantification for Research and Biomarker Analysis Guaranteed Precision, Quantitation and Reproducibility Our readily available or custom developed quantitative assays help you achieve your research and biomarker validation objectives with precise and fully validated methods. Our targeted assays and panels cover >1000 metabolites and lipids across a wide range of biochemical classes, metabolic pathways and physiological processes, and they can be customized to best fit any application. Informing the Entire Biomarker Revealing Custom Assay Drug Discovery & Development Microbiome Development Development Cycle & Validation Function Targeted assays are valuable for rapidly and From discovery to commercialization, Build upon the system-wide view of If one of our existing targeted assay panels accurately establishing pharmacodynamics, improve biological understanding by tracking Metabolon’s global metabolomics with doesn’t meet your needs, our experienced fueling translational studies, gauging efficacy biomarkers with targeted metabolite assays. additional insights from a series of microbiome team of scientists can create a custom assay and safety, and informing post-market focused Targeted Assays. specifically for your area of interest. We have surveillance studies. The role of biomarkers is expanding to developed hundreds of customized assays inform new indications and targets, patient Measure the effects of microbiome-related representing >1,000 metabolites from all areas With several matrices supported, you can segmentation and novel mechanisms of analytes with absolute quantitation for of the metabolome with multiplexing support. gain more profound insights from various action. According to the context of use of the most precise and systematic view of applications, including microbiome research your biomarkers, Metabolon can guide you to microbiome related activity. All of our assays are validated for Research and bioprocessing. ensure study integrity and high-quality data use only (RUO) or Good Clinical Practice generation in compliance with regulatory (GCP)/ Good Clinical Laboratory Practice standards. (GCLP) and Clinical Laboratory Improvement Amendments (CLIA). The Power of Our Technology GLOBAL ASSAY 5,400+ metabolites 70 major pathways PANELS & TARGETED ASSAYS 1,100 individual lipid species ▶ Our unique platform provides single point quantitation of 14 lipid classes, Targeted Assays including principal phospholipid, sphingolipid, and neutral lipid classes Focus on specific pathways and metabolites with custom or pre-developed assays that deliver absolute quantification for research 450+ metabolites covered by ready- and biomarker applications to-use absolute quantification assays ▶ Fit-For-Purpose Biomarker Validation ▶ Capability to adhere to Good Clinical Practice (GCP)/ Good Clinical Laboratory Practice (GCLP) standards ▶ Extensive Method Validation according to FDA Bioanalytical Method Validation Guidance, 2018 or EMA Guideline on Bioanalytical Method Validation, 2011 ▶ Capability to develop/validate methods and perform diagnostic testing on human samples according to regulations certified by Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP) for diagnostic testing on human samples OUR EXPERTISE ™ 200+ patents Precision Metabolomics Global Assay ™ 2,000+ publications Cast a wide research net with our global Complex Lipid Panel metabolomics technology. Identify Our insightful lipidomics approach * comprehensively quantitates up to 10,000+ studies 5,400+ metabolites across 1,100 lipid species/sample 70 major biochemical pathways. *The number of metabolites will vary based on sample type/amount TARGETED ASSAY Targeted assays are an ideal follow-up to the global screening of hundreds to thousands of metabolites with our revolutionary Precision Metabolomics™ The Core of a Biomarker Technology. Following the identification of candidate biomarkers, you can select pre-developed assays from an ever-expanding set of >1,000 metabolites and lipids or initiate the development of a custom assay. Assays can inform a research or Development Program clinical trial setting. Discovery Development Commercialization Candidate Research Use Clinical Trial Validated Diagnostic Biomarker Biomarker Biomarker Test Precision Metabolomics™ Clinical Diagnostics Global Assay Advance your biomarkers to Cast a wide research net with commercial diagnostic testing. our global metabolomics technology. Identify 5,400+ metabolites* across 70 major Targeted Assays biochemical pathways. Focus on specific pathways and metabolites with custom or pre-developed assays that deliver absolute quantification for research and biomarker applications. *The number of metabolites will vary based on sample type/amount TARGETED ASSAY Guide Your Biomarker Development With Expert Consultation Each project begins with a scientist-to-scientist consultation to determine your assay needs, including regulatory requirements and project timeline. In doing so, we explore how to best meet those needs through existing assays, custom-developed assays, or a combination of both. In-depth institutional knowledge of metabolic pathways, along with our deep expertise in metabolite-based mass spectrometry, guides the selection of candidate biomarkers. The focus is on ensuring that the critical aspects of the subsequent study or trial are clearly defined and that the assays and multiplexing scheme most effectively meet your needs. Define Your Path Sample Testing ▶ GCP or RUO & Reporting ▶ Manage samples through ▶ Pre-developed or accessioning and chain Custom Assay of custody tracking Assays can be customized based on ▶ Create project- specific worksheet your needs and developed and validated for data management for RUO or run under GCP/GCLP. in a validated LIMS environment Expert Scientific Consult Our expertise throughout the continuum of ▶ Report study results & ▶ Identify needs/constraints biomarker development makes Metabolon plan next steps ▶ Assess technical feasibility an exceptional partner for validated ▶ Evaluate reference material & methods assay development and analysis. ▶ Collaborate on regulatory needs Targeted Assays in Drug Development Clinical Development Regulatory Basic Preclinical Filing and/or Discovery Research Development Phase I Phase II Phase III Approval and Launch Research Purposes Phase I, II, III Clinical Diagnostics Support Capabilities ▶ Expert consultation and routine scientist-to-scientist Readily Available Quantitative Metabolite Clinical Studies Capability to develop and validate methods communication Assays or Custom Assay Development and perform diagnostic testing on human Fit-For-Purpose Biomarker Validation. ▶ Dedicated team of scientists, method development according to ISO 9001:2015 standards. samples according to CLIA regulations and and sample analysis experts supporting all aspects of Capability to adhere to GCP/GCLP standards the College of American Pathologists (CAP) biomarker testing with extensive method validation according standards for diagnostic testing on human ▶ Oversight by experienced program manager throughout the process to FDA Bioanalytical Method Validation samples. Guidance, 2018 or EMA Guideline on ▶ Independent quality assurance review of processes, data and reports Bioanalytical Method Validation, 2011. TARGETED ASSAY Metabolite Assays and Panels Assays can be customized based on your needs and developed and validated for RUO or run under GCP/GCLP. Metabolic Pathway Metabolites Classes Microbiome Related Metabolites ▶ Central Carbon Metabolism ▶ Glycolysis ▶ Acylcarnitines ▶ Short Chain Fatty Acids ▶ Cholesterol Metabolism ▶ Pyrimidine Metabolism ▶ Amino Acids ▶ Bile Acids ▶ Fatty Acid Metabolism ▶ Porphyrin Metabolism ▶ Bile Acids ▶ Sulfated Bile Acids ▶ Purine Catabolism ▶ Steroid Metabolism ▶ Sulfated Bile Acids ▶ Trimethylamine N-Oxide (TMAO) ▶ Kynurenine/ Tryptophan Ratio ▶ Histidine and Histamine ▶ Polyamines ▶ Indoles ▶ Asymmetric dimethylarginine/ Symmetric Metabolism ▶ Ketone Bodies ▶ Kynurenine/Tryptophan Ratio dimethylarginine (ADMA/SDMA) Ratio ▶ Free Fatty Acids ▶ Serotonin (5-HT) ▶ Leucine, Isoleucine and Valine Metabolism ▶ Short Chain Fatty Acids ▶ Targeted Panels Nitric Oxide Pathway ▶ Total Cholesterol ▶ ▶ Complex Lipids Glutathione Pathway ▶ Total Triacylglycerides (TAGs) ▶ ▶ Sebum Lipids Methionine Cycle ▶ Nucleosides and Nucleotides ▶ ▶ Stratum Corneum Lipids Urea Cycle ▶ Oxylipins ▶ ▶ Metal Ions NAD Metabolism ▶ Cofactors and Vitamins ▶ Pentose Phosphate ▶ Sphingosine-1-phosphate TARGETED ASSAY Disease Related Metabolite Assays Neurological Disorders Metabolic Disorders Cardiovascular Diseases Gut Health and Wellness Liver Diseases, NAFLD, NASH Inflammation & ▶ Complex Lipids ▶ Complex Lipids ▶ Complex Lipids ▶ Short Chain Fatty Acids ▶ Complex Lipids Oxidative Stress ▶ Glutathione Pathway ▶ Bile Acids ▶ Malonylcarnitine Assay ▶ Total Cholesterol ▶ Bile Acids ▶ Acylcarnitines ▶ Fatty Acid Metabolism ▶ Cholesterol Metabolism ▶ Salivary Glucose ▶ Total Triacylglycerides (TAGs) ▶ Sulfated Bile Acids ▶ Bile Acids ▶ Oxylipins ▶ Asymmetric dimethylarginine/ ▶ Total Cholesterol ▶ Fatty Acid Metabolism ▶ 7-α-Hydroxy-4-cholesten-3-one ▶ Sulfated Bile Acids Symmetric dimethylarginine ▶ Cholesterol Metabolism ▶ Trimethylamine N-Oxide (TMAO) ▶ Trimethylamine N-Oxide (TMAO) ▶ 7-α-Hydroxy-4-cholesten-3-one Bone Health (ADMA/SDMA) Ratio ▶ Total Triacylglycerides (TAGs) ▶ Asymmetric dimethylarginine/