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Merck

Biomarker & Metabolite Standards

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Biomarkers are biological molecules found in blood, body fluids, or tissues that act as measurable indicators of biological processes or conditions. Based on their purpose in a biological process or a therapeutic response, biomarkers are primarily classified into susceptibility/risk biomarkers, diagnostic biomarkers, monitoring biomarkers, prognostic biomarkers, predictive biomarkers, pharmacodynamic biomarkers, and safety biomarkers.

Metabolites, including amino acids, lipids, peptides, nucleic acids, carbohydrates, vitamins, and minerals, are small molecules produced as intermediates or end products of metabolic reactions, and the study of these molecules within cells, tissues, organs, and biofluids is known as metabolomics. Metabolites are classified as primary or secondary, endogenous or exogenous, based on their roles in physiological processes, disease states, and their origins within or outside the body.

Metabolite and biomarker standards are indispensable tools in clinical and diagnostic testing, as they provide essential insights into the metabolic state and disease progression, enabling precise diagnosis, prognosis, and personalized treatment strategies. To achieve this, the use of high-quality metabolite and biomarker references is crucial, as they ensure the accuracy, consistency, and reproducibility of test results, thereby enhancing the reliability of clinical decisions and research outcomes.

We offer a broad range of metabolite and biomarker reference materials tailored for mass spectrometry-based metabolomics and biomarker testing. The metabolite standards are suitable for use in all kinds of metabolite testing, including metabolic panel testing, basic metabolic panel testing, newborn screening tests, and inborn errors of metabolism screening tests. Our biomarker reference materials also support different biomarker testing methods and biomarker tests, such as biomarker testing for alcohol, biomarker testing for athletes, inflammatory biomarkers test, and biomarker test for cancer among others.

Our products support a variety of applications, including metabolic profiling, clinical and diagnostic testing, target analysis for novel biomarker identification, pharmaceutical research, and endocrinology. Our collection includes clinically significant endogenous compounds, such as Seraseq® Oncology and NIPT products for genomics, as well as key metabolites like amino acids, lipids, carbohydrates, bile acids, vitamin D, catecholamines, neurotransmitters, and hormones related to male, female, neonatal, and thyroid health.

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Seraseq® NIPT Testing Reference Materials

Seraseq® NIPT Reference Materials are high-quality, patient-like controls designed to support the entire Non-Invasive Prenatal Testing (NIPT) workflow, from assay development to routine quality control. Derived from maternal plasma and mimicking clinical samples, they preserve the native fetal and maternal cfDNA characteristics, to ensure compatibility with various assay technologies and platforms, including whole genome (WG) & SNP-based fetal fraction estimation methods. These reference materials provide extensive coverage, including common aneuploidies such as trisomy 21, 18, 13, and sex chromosome abnormalities like 22q11 microdeletion. Manufactured under cGMP compliance in ISO 13485-certified facilities, Seraseq® NIPT reference materials ensure lot-to-lot consistency and have a long shelf life, providing stability and reliability. Also, the convenient single-vial format, simulating plasma, allows for easy integration into the NIPT testing workflow.

Seraseq® Reference Materials for NGS Cancer Testing

Seraseq® oncology products provide a comprehensive suite of reference materials designed to support the development, validation, and monitoring of next-generation sequencing (NGS) assays in precision oncology. These highly multiplexed, patient-like materials are available in various formats, including DNA, RNA, and circulating tumor DNA (ctDNA), and cover a wide range of variant types such as SNVs, INDELs, CNVs, SVs, and RNA fusions. Ideal for tumor profiling, immuno-oncology, liquid biopsy, and disease monitoring, Seraseq® oncology reference materials ensure consistency, reproducibility, and confidence in results, making them a leading choice for advancing cancer diagnostics and personalized treatment strategies.

Reference Materials for Hormone Testing

Our wide selection of hormone reference materials includes Cerilliant® certified reference material (CRM) solutions and VETRANAL® analytical standards for the accurate and reproducible detection of hormone metabolites. These standards are available in both neat and solution forms, compatible with HPLC and GC analysis, ensuring reliable and precise results.

Reference Materials of Amino acid metabolites

We offer a wide selection of analytical standards and certified reference materials (CRMs) for amino acids, including both native and stable isotope-labeled internal standards. Our products are available as single solutions or multi-analyte mixes, optimized for use in GC/MS and LC/MS platforms.

Our TraceCERT® certified reference materials provide consistent, reliable results for various quantitative applications such as preparing internal standards, system suitability tests, linearity verification, and proficiency testing. The stable, quantitative solution format ensures ease of use, reduced material waste, and increased efficiency, with certified concentration values delivering improved consistency and accuracy in clinical and research settings.

Reference Materials for Hydroxyvitamin D

25-Hydroxyvitamin D is a stable and widely recognized metabolite used to clinically assess vitamin D levels in the blood. Our range of 25-hydroxy vitamin D standards includes certified reference material solutions, available in both native and isotope-labeled forms, ensuring accuracy and reliability in clinical testing.

Reference Materials for Catecholamines and biogenic amines

Catecholamines are amines produced by the adrenal glands, acting as both hormones and neurotransmitters. Key catecholamines include dopamine, epinephrine (adrenaline), and norepinephrine (noradrenaline), all derived from the amino acid L-tyrosine. We provide a wide range of certified reference materials (CRMs) for catecholamine metabolites, available in both single- and multi-component solutions, to support accurate clinical analysis.



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