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    Improved Detection of HER2 by a Quasi-Targeted Proteomics Approach Using Aptamer-Peptide Probe and Liquid Chromatography-Tandem Mass Spectrometry.
    Clin Chem 2017 Nov 15. Epub 2017 Nov 15.
    Nanjing Medical University, Nanjing, China;
    Background: Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is a particularly aggressive type of the disease. To date, much evidence has indicated that accurate HER2 status detection is crucial for prognosis and treatment strategy selection. Thus, bioanalytical techniques for early and accurate detection of HER2 have the potential to improve patient care. Read More

    Addressing the Perfect Storm: Biomarkers in Obesity and Pathophysiology of Cardiometabolic Risk.
    Clin Chem 2017 Nov 14. Epub 2017 Nov 14.
    Molecular Epidemiology Research Group, Max Delbrück Center for Molecular Medicine in the Helmholtz Association, Berlin, Germany;
    Background: The worldwide rise of obesity has provoked intensified research to better understand its pathophysiology as a means for disease prevention. Several biomarkers that may reflect various pathophysiological pathways that link obesity and cardiometabolic diseases have been identified over the past decades.

    Content: We summarize research evidence regarding the role of established and novel obesity-related biomarkers, focusing on recent epidemiological evidence for detrimental associations with cardiometabolic diseases including obesity-related cancer. Read More

    Low- and High-renin Heart Failure Phenotypes with Clinical Implications.
    Clin Chem 2017 Nov 14. Epub 2017 Nov 14.
    Department of Internal Medicine II, Clinical Division of Cardiology, Medical University of Vienna, Vienna, Austria;
    Background: Blockade of the renin-angiotensin system (RAS) represents a main strategy in the therapy of heart failure with reduced ejection fraction (HFrEF), but the role of active renin concentration (ARC) for guiding therapy in the presence of an RAS blockade remains to be established. This study assessed angiotensin profiles of HFrEF patients with distinct RAS activations as reflected by ARC.

    Methods: Two cohorts of stable chronic HFrEF patients on optimal medical treatment (OMT) were enrolled. Read More

    Multiplex Gene Expression Profiling of In Vivo Isolated Circulating Tumor Cells in High-Risk Prostate Cancer Patients.
    Clin Chem 2017 Nov 9. Epub 2017 Nov 9.
    Analysis of Circulating Tumor Cells Lab, Department of Chemistry, University of Athens, Athens, Greece
    Background: Molecular characterization of circulating tumor cells (CTCs) is important for selecting patients for targeted treatments. We present, for the first time, results on gene expression profiling of CTCs isolated in vivo from high-risk prostate cancer (PCa) patients compared with CTC detected by 3 protein-based assays-CellSearch®, PSA-EPISPOT, and immunofluorescence of CellCollector® in vivo-captured CTCs-using the same blood draw.

    Methods: EpCAM-positive CTCs were isolated in vivo using the CellCollector from 108 high-risk PCa patients and 36 healthy volunteers. Read More

    Multiple Hotspot Mutations Scanning by Single Droplet Digital PCR.
    Clin Chem 2017 Nov 9. Epub 2017 Nov 9.
    Circulating Tumor Biomarkers Laboratory, SiRIC, Translational Research Department, Institut Curie, PSL Research University, Paris, France
    Background: Progress in the liquid biopsy field, combined with the development of droplet digital PCR (ddPCR)(12), has enabled noninvasive monitoring of mutations with high detection accuracy. However, current assays detect a restricted number of mutations per reaction. ddPCR is a recognized method for detecting alterations previously characterized in tumor tissues, but its use as a discovery tool when the mutation is unknown a priori remains limited. Read More

    Leukocyte Counts Based on DNA Methylation at Individual Cytosines.
    Clin Chem 2017 Nov 8. Epub 2017 Nov 8.
    Helmholtz-Institute for Biomedical Engineering, Stem Cell Biology and Cellular Engineering, RWTH Aachen University Medical School, Aachen, Germany
    Background: White blood cell counts are routinely measured with automated hematology analyzers, by flow cytometry, or by manual counting. Here, we introduce an alternative approach based on DNA methylation (DNAm) at individual CG dinucleotides (CpGs).

    Methods: We identified candidate CpGs that were nonmethylated in specific leukocyte subsets. Read More

    Wearables for Promoting Physical Activity.
    Clin Chem 2017 Nov 8. Epub 2017 Nov 8.
    Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee WI.
    Background: The rapid expansion and popularity of consumer-wearable physical activity monitors (WPAMs) has enabled the integration of technology into physical activity (PA) intervention, deployment, and evaluation. This brief review reports on the accuracy of consumer-WPAMs, considers the intervention effects of using consumer-WPAMs, and offers future considerations as the proliferation of this area of product development and consumer use continues to escalate.

    Content: The studies reviewed document the utility for consumer-WPAMs to objectively assess PA, with output metrics similar to research-grade activity monitors. Read More

    Neuropeptides in Obesity and Metabolic Disease.
    Clin Chem 2017 Nov 2. Epub 2017 Nov 2.
    Department of Clinical Biochemistry, Metabolic Research Laboratories, University of Cambridge, Cambridge, England.
    Background: The global rise in the prevalence of obesity and associated comorbidities such as type 2 diabetes, cardiovascular disease, and cancer represents a major public health concern.

    Content: Studies in rodents with the use of global and targeted gene disruption, and mapping of neurocircuitry by using optogenetics and designer receptors exclusively activated by designer drugs (DREADDs) have greatly advanced our understanding of the neural control of body weight. In conjunction with analytical chemistry techniques involving classical immunoassays and mass spectrometry, many neuropeptides that are key to energy homeostasis have been identified. Read More

    Planning Risk-Based SQC Schedules for Bracketed Operation of Continuous Production Analyzers.
    Clin Chem 2017 Nov 2. Epub 2017 Nov 2.
    Westgard QC, Inc., Madison WI.
    Background: To minimize patient risk, "bracketed" statistical quality control (SQC) is recommended in the new CLSI guidelines for SQC (C24-Ed4). Bracketed SQC requires that a QC event both precedes and follows (brackets) a group of patient samples. In optimizing a QC schedule, the frequency of QC or run size becomes an important planning consideration to maintain quality and also facilitate responsive reporting of results from continuous operation of high production analytic systems. Read More

    Adiposity and Genetic Factors in Relation to Triglycerides and Triglyceride-Rich Lipoproteins in the Women's Genome Health Study.
    Clin Chem 2017 Nov 2. Epub 2017 Nov 2.
    Preventive Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA;
    Background: Previous results from Scandinavian cohorts have shown that obesity accentuates the effects of common genetic susceptibility variants on increased tri-glycerides (TG). Whether such interactions are present in the US population and further selective for particular TG-rich lipoprotein subfractions is unknown.

    Methods: We examined these questions using body mass index (BMI) and waist circumference (WC) among women of European ancestry from the Women's Genome Health Study (WGHS) (n = 21840 for BMI; n = 19313 for WC). Read More

    Policies to Prevent Obesity and Promote Healthier Diets: A Critical Selective Review.
    Clin Chem 2017 Nov 2. Epub 2017 Nov 2.
    Cornell University, Ithaca, NY.
    Background: Obesity has risen dramatically in recent decades in the US and most other countries of the world. This has led to a search for public policies and other interventions that can prevent obesity and improve diets. However, there remain considerable uncertainty and confusion about the effectiveness for many potential policies. Read More

    The Impact of Obesity on Medical Care Costs and Labor Market Outcomes in the US.
    Clin Chem 2017 Nov 2. Epub 2017 Nov 2.
    Department of Economics, Lehigh University, Bethlehem, PA.
    Background: The prevalence of obesity has risen dramatically in most countries of the world, and the economic consequences of obesity are not well understood.

    Methods: We analyzed data from the Medical Expenditure Panel Survey (MEPS) for 2001-2015 and estimated the percentage of healthcare costs that were associated with adult obesity, both for the US as a whole and for the most populous states. We also reviewed the literature on the impact of obesity on economic outcomes such as medical care costs, employment, and wages. Read More

    New Insights into Cardiac and Vascular Natriuretic Peptides: Findings from Young Adults Born with Very Low Birth Weight.
    Clin Chem 2017 Nov 2. Epub 2017 Nov 2.
    Department of Medicine, University of Otago, Christchurch, New Zealand.
    Background: In community studies, plasma B-type natriuretic peptide (BNP) is positively associated with cardiovascular disorders. Those born with very low birth weight (VLBW) have increased risk of metabolic and vascular disorders in later life, but plasma concentrations of natriuretic peptides have not been studied. The objectives here were to evaluate BNP and C-type natriuretic peptide (CNP)-a putative marker of vascular risk-in young adults born with VLBW. Read More

    Precision Medicine in Obesity and Type 2 Diabetes: The Relevance of Early-Life Exposures.
    Clin Chem 2017 Nov 2. Epub 2017 Nov 2.
    Department of Clinical Sciences, Genetic and Molecular Epidemiology Unit, Lund University, Skåne University Hospital Malmö, Malmö, Sweden;
    Background: Type 2 diabetes is highly prevalent and devastating. Obesity is a diabetogenic factor, driving insulin resistance and a compensatory demand for increased insulin secretion from the pancreatic β cells; a failure to address this demand results in diabetes. Accordingly, primary and secondary prevention of obesity are at the core of diabetes prevention programs. Read More

    Noninvasive Prenatal Diagnosis of Single-Gene Disorders by Use of Droplet Digital PCR.
    Clin Chem 2017 Nov 2. Epub 2017 Nov 2.
    Department of Bioengineering, Stanford University, Stanford, CA;
    Background: Prenatal diagnosis in pregnancies at risk of single-gene disorders is currently performed using invasive methods such as chorionic villus sampling and amniocentesis. This is in contrast with screening for common aneuploidies, for which noninvasive methods with a single maternal blood sample have become standard clinical practice.

    Methods: We developed a protocol for noninvasive prenatal diagnosis of inherited single-gene disorders using droplet digital PCR from circulating cell-free DNA (cfDNA) in maternal plasma. Read More

    Pharmacotherapy for Patients with Obesity.
    Clin Chem 2017 Oct 20. Epub 2017 Oct 20.
    Pennington Biomedical Research Center, Baton Rouge, LA.
    Background: Although pharmacotherapy is not the cornerstone of obesity treatment, it is a valuable tool that could be considered for patients who have not had adequate benefit from lifestyle interventions or who have difficulty maintaining initial weight loss over longer periods.

    Content: This review focuses on the role of antiobesity drugs, the mechanisms by which the drugs work, potential pharmacological targets in the neural control of food intake and regulation of body weight, the history of antiobesity drugs, a summary of efficacy and safety data from clinical trials, and the clinical application of pharmacotherapy. Currently, 5 approved drug therapies are available in the US for long-term weight management, with only 2 of these meeting the stronger Food and Drug Administration (FDA) criteria of 5% weight loss relative to a placebo after 1 year and others receiving approval based on the categorical criterion of the proportions of patients achieving 5% weight loss. Read More

    Activity of the Calcineurin Pathway in Patients on the Liver Transplantation Waiting List: Factors of Variability and Response to Tacrolimus Inhibition.
    Clin Chem 2017 Nov;63(11):1734-1744
    U850 INSERM, University of Limoges, CHU Limoges, FHU SUPORT, Limoges, France;
    Background: We sought to evaluate, in patients on a liver transplantation waiting list, potential biomarkers of the base calcineurin pathway activity with use of a new model of nonstimulated peripheral blood mononuclear cells (PBMC) and ex vivo response to tacrolimus (TAC).

    Methods: The calcineurin pathway activity was explored ex vivo in stimulated and nonstimulated PBMC from 19 patients. The inhibition of NFAT1 translocation to PBMC nuclei, expression of intracellular IL-2, and membrane CD25 in different T-cell subsets were measured by multiparametric flow cytometry before and after exposure to TAC. Read More

    Protein Turnover Measurements in Human Serum by Serial Immunoaffinity LC-MS/MS.
    Clin Chem 2017 Oct 20. Epub 2017 Oct 20.
    Biomedicine Design, Worldwide Research & Development, Pfizer, Inc., Andover, MA.
    Background: The half-life of target proteins is frequently an important parameter in mechanistic pharmacokinetic and pharmacodynamic (PK/PD) modeling of biotherapeutics. Clinical studies for accurate measurement of physiologically relevant protein turnover can reduce the uncertainty in PK/PD model-based predictions, for example, of the therapeutic dose and dosing regimen in first-in-human clinical trials.

    Methods: We used a targeted mass spectrometry work flow based on serial immunoaffinity enrichment of multiple human serum proteins from a [5,5,5-(2)H3]-L-leucine tracer pulse-chase study in healthy volunteers. Read More

    Adipose Tissue LPL Methylation is Associated with Triglyceride Concentrations in the Metabolic Syndrome.
    Clin Chem 2017 Oct 18. Epub 2017 Oct 18.
    Unidad de Gestión Clínica de Endocrinología y Nutrición del Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga (IBIMA), Universidad de Málaga, Málaga, Spain.
    Background: DNA methylation is one of the epigenetic mechanisms that regulate gene expression. DNA methylation may be modified by environmental and nutritional factors. Thus, epigenetics could potentially provide a mechanism to explain the etiology of metabolic disorders, such as metabolic syndrome (MetS). Read More

    Systematic Review and Metaanalysis Comparing the Bias and Accuracy of the Modification of Diet in Renal Disease and Chronic Kidney Disease Epidemiology Collaboration Equations in Community-Based Populations.
    Clin Chem 2017 Oct 18. Epub 2017 Oct 18.
    Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom;
    Background: The majority of patients with chronic kidney disease are diagnosed and monitored in primary care. Glomerular filtration rate (GFR) is a key marker of renal function, but direct measurement is invasive; in routine practice, equations are used for estimated GFR (eGFR) from serum creatinine. We systematically assessed bias and accuracy of commonly used eGFR equations in populations relevant to primary care. Read More

    Increased Plasma Ferritin Concentration and Low-Grade Inflammation-A Mendelian Randomization Study.
    Clin Chem 2017 Oct 16. Epub 2017 Oct 16.
    Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark;
    Background: It is unknown why increased plasma ferritin concentration predicts all-cause mortality. As low-grade inflammation and increased plasma ferritin concentration are associated with all-cause mortality, we hypothesized that increased plasma ferritin concentration is genetically associated with low-grade inflammation.

    Methods: We investigated whether increased plasma ferritin concentration is associated with low-grade inflammation [i. Read More

    Human Toxicity Caused by Indole and Indazole Carboxylate Synthetic Cannabinoid Receptor Agonists: From Horizon Scanning to Notification.
    Clin Chem 2017 Oct 16. Epub 2017 Oct 16.
    National Institute for Health Research Health Protection Research Unit in Chemical and Radiation Threats and Hazards, Medical Toxicology Centre, Newcastle University, Newcastle upon Tyne, UK.
    Background: The emergence of novel psychoactive substances (NPS), particularly synthetic cannabinoid receptor agonists (SCRA), has involved hundreds of potentially harmful chemicals in a highly dynamic international market challenging users', clinicians', and regulators' understanding of what circulating substances are causing harm. We describe a toxicovigilance system for NPS that predicted the UK emergence and identified the clinical toxicity caused by novel indole and indazole carboxylate SCRA.

    Methods: To assist early accurate identification, we synthesized 5 examples of commercially unavailable indole and indazole carboxylate SCRA (FUB-NPB-22, 5F-NPB-22, 5F-SDB-005, FUB-PB-22, NM-2201). Read More

    Deactivated CRISPR Associated Protein 9 for Minor-Allele Enrichment in Cell-Free DNA.
    Clin Chem 2017 Oct 16. Epub 2017 Oct 16.
    Department of Bioengineering, Stanford University School of Medicine, Stanford, CA;
    Background: Cell-free DNA (cfDNA) diagnostics are emerging as a new paradigm of disease monitoring and therapy management. The clinical utility of these diagnostics is relatively limited by a low signal-to-noise ratio, such as with low allele frequency (AF) mutations in cancer. While enriching for rare alleles to increase their AF before sample analysis is one strategy that can greatly improve detection capability, current methods are limited in their generalizability, ease of use, and applicability to point mutations. Read More

    Prospective Validation of a Biomarker-Based Rule Out Strategy for Functionally Relevant Coronary Artery Disease.
    Clin Chem 2017 Oct 16. Epub 2017 Oct 16.
    Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.
    Background: This study aimed to prospectively advance a rule-out strategy for functionally significant coronary artery disease (CAD) by use of high-sensitivity cardiac troponin I (hs-cTnI) from bench to bedside, by application of a 3-step approach: validation in serum, correlation in plasma, and application on a clinical platform.

    Methods: Patients without known CAD referred for rest/stress myocardial perfusion single-photon emission tomography/computer tomography (MPI-SPECT/CT) were assigned to 3 consecutive cohorts: validation, correlation, and application. Functionally relevant CAD was adjudicated with the use of expert interpretation of MPI-SPECT/CT and, if available, coronary angiography. Read More

    Obesity and Cancer: Evidence, Impact, and Future Directions.
    Clin Chem 2017 Oct 16. Epub 2017 Oct 16.
    Department of Medicine, Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO.
    Background: Mounting evidence, particularly from prospective epidemiologic studies but with additional support from animal models and mechanistic studies, supported conclusions in 2016 by the International Agency for Research on Cancer (IARC)(3) in their review of the preventive effects of weight control on cancer risk.

    Content: The workgroup concluded that obesity is causally related to cancer at 13 anatomic sites (esophagus: adenocarcinoma; gastric cardia; colon and rectum; liver; gallbladder; pancreas; breast: postmenopausal; uterine endometrial; ovary; kidney: renal cell; meningioma; thyroid; and multiple myeloma). Further, avoiding weight gain and excess body fat will prevent cancer. Read More

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