Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Biomarker testing”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,459 records · Page 81Linked to original sources
PubMed2004

Genomic biomarkers for cancer assessment: implementation challenges for laboratory practice.

Genomic biomarkers are an emerging class of laboratory tests, which present special implementation challenges for clinical laboratory services, compared to conventional laboratory tests. These challenges, which include analytical, bioinformatics, bioethical, interpretation and commercialization issues, represent real obstacles to widespread implementation of these tests. Technical challenges include the capacity to detect and identify many different kinds of markers for different diseases in a short time period, capacity to identify simultaneously gene rearrangements, amplification, inhibition, deletions and replications. Bioinformatics challenges include rapid analysis of genomic data, as well as the cross reference to other genomic data, and to other laboratory tests. Bioethical issues relate to consent to retain and use genetic data, which may be obtained inadvertently during analysis for genomic markers. Interpretation challenges include observations that the particular genomic markers may not be independent variables, as other undetected genomic alterations could invalidate or alter genomic marker interpretation. Further, as early experience with predictive genetic markers for cancer has shown, proprietary commercial interests may conflict with public health values of identifying genomic markers in subject populations. Based on our 10 years of experience with genomic biomarkers, important implementation strategies for genomic markers include development of:Standard high throughput analyzers capable of detecting any alteration of any genomic variant at any time. Bioinformatics analysis online, coupled to stored patient data. Laboratory service framework that preserves confidentiality but integrates genomic data with other laboratory tests. Laboratory service framework, which links consents, genomic analysis, reports to both specimen and data repositories. Overall, the laboratory service challenges for genomic markers are to manage very large analytical sets and very large data sets in finite time with responsible interpretation, all within finite funding. To meet these challenges, implementation strategies beyond the one disease, one diagnosis, one genomic marker concept must begin now.

Biomarkers, Tumor↗
PubMed2005

Regional comparisons of coastal sediment contamination detected by a biomarker (P450 HRGS; EPA Method 4425).

Pollution investigations by the Center for Coastal Monitoring and Assessment of the National Oceanic and Atmospheric Administration (NOAA) have been conducted since 1984 and have incorporated extensive biological and chemical analyses. Since 1993, one of the biological tests utilized in these studies has been the biomarker P450HRGS, which is more recently described as EPA Method 4425. Extracts of sediments are applied to a human cell line with a reporter gene (firefly luciferase) at the CYP1A1 site. Light produced by the extracts is a function of the concentrations and potencies of those compounds with an affinity for Ah-receptor (certain polycyclic aromatic hydrocarbons, polychlorinated biphenyls, and dioxins/ furans). These compounds are carcinogenic and can produce chronic toxicity, and those containing chlorine are persistent and bioaccumulated. Nineteen coastal regions and 1309 samples from the three U.S. coasts have been evaluated as part of the NOAA investigations. The stratified random sampling approach used by NOAA provides estimates of the areas (km2) of each region containing levels of the compounds above thresholds. From analysis of the database, sediments with concentrations at or below 11 microg benzo[a]pyrene equivalents (B[a]PEq)/g would not be expected to produce effects on the benthos. At 32 microg B[a]PEq/g and above there is the potential for impacts on the biota, and above 60 microg/g, the degradation of the benthic community has been observed. Several of the regional surveys found no samples at or above 60 microg B[a]PEq/g, but 60% of the samples from New York Harbor (280 km2) were above this level. Analyses of data from Puget Sound and Chesapeake Bay demonstrate an increase in samples above 32 microg B[a]PEq/g in more populated and industrial regions. Method 4425 serves as both a biomarker, simulating the response of an organism (with CYP1A) exposed to inducing compounds, and as a bioanalytical technique measuring the levels of these chemicals in the samples. A targeted investigation of the distribution of the three important classes of compounds identified by Method 4425 would be more cost-effective by first screening samples by this method before expending substantial funds in the detailed chemical analysis of all samples.

Biomarkers↗
PubMed2004

The 'Coral Bulker' fuel oil spill on the north coast of Portugal: spatial and temporal biomarker responses in Mytilus galloprovincialis.

In December 2000, the ship 'Coral Bulker' ran aground at the entrance of the port of Viana do Castelo (North-west coast of Portugal). A large amount of fuel oil was spilled and part of it reached the shore. To evaluate the spatial and temporal impact of this oil spill, a field study, and several laboratory toxicity tests were performed using Mytilus galloprovincialis as biological indicator of environmental contamination and the biomarkers glutathione S-transferases (GSTs) and acetylcholinesterase (AChE) as indicative criteria. Fifteen days after the oil spill, mussels collected at stations located near the ship presented higher and lower values of GSTs and AChE activity, respectively. These results, and those obtained in the laboratory toxicity tests, evidence that these biomarkers were sensitive indicators of exposure to this kind of pollution and were able to monitor a spatial impact of the oil spill of at least 10 km, confirming the higher level of contamination near the ship and a contamination gradient along the sampling stations. One year after the accident, such a contamination gradient was no longer evident. This study highlight the potential suitability of a biomarker approach for assessing spatial and temporal impacts of marine pollution accidents, such as fuel oil spills, suggesting the inclusion of these biomarkers in risk assessment studies, as cost-effective and early warning recognized tools. Major advantages and limitations of the biomarker approach used in this study are further discussed.

Acetylcholinesterase↗
PubMed2026

Systemic treatment of advanced pancreatic cancer: A Comprehensive Review.

IMPORTANCE: Pancreatic adenocarcinoma (PDAC) is an uncommon but potentially catastrophic diagnosis with historically poor prognosis. It is the tenth most prevalent cancer in the US & UK. Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies worldwide, with a five-year survival rate of approximately 10%. Despite increasing understanding of its molecular biology, systemic treatment options for advanced disease remain limited, and survival outcomes have improved only modestly over the past decade. OBSERVATIONS: This narrative review traces the evolution of systemic therapy for advanced PDAC from gemcitabine monotherapy through the landmark FOLFIRINOX (PRODIGE trial) and gemcitabine/nab-paclitaxel (MPACT trial) combination regimens, which remain the standard of care. Second-line options including liposomal irinotecan plus 5-FU/LV (NAPOLI-1) and maintenance olaparib for germline BRCA1/2-mutated disease (POLO) are also reviewed. Emerging data on sequential treatment strategies (SEQUENCE trial), biomarker-driven treatment selection (PRIMUS-001, PASS-01), and precision medicine approaches targeting actionable molecular subgroups, including dMMR/MSI-H, NTRK fusions, and homologous recombination deficiency are discussed. Real-world evidence comparing FOLFIRINOX and gemcitabine/nab-paclitaxel is critically appraised, including the challenges of patient selection, tolerance, and applicability outside clinical trial settings. CONCLUSION AND RELEVANCE: Despite incremental progress, the treatment landscape of advanced PDAC remains challenging. Molecular stratification and biomarker-driven precision oncology represent the most promising path forward. This review serves as a clinical reference for physicians managing advanced pancreatic cancer, highlighting current evidence, evidence limitations, and future research priorities including prospective biomarker-driven trials and improved access to genomic testing.

Biomarkers↗
PubMed2006

Protein biomarker discovery and validation: the long and uncertain path to clinical utility.

Better biomarkers are urgently needed to improve diagnosis, guide molecularly targeted therapy and monitor activity and therapeutic response across a wide spectrum of disease. Proteomics methods based on mass spectrometry hold special promise for the discovery of novel biomarkers that might form the foundation for new clinical blood tests, but to date their contribution to the diagnostic armamentarium has been disappointing. This is due in part to the lack of a coherent pipeline connecting marker discovery with well-established methods for validation. Advances in methods and technology now enable construction of a comprehensive biomarker pipeline from six essential process components: candidate discovery, qualification, verification, research assay optimization, biomarker validation and commercialization. Better understanding of the overall process of biomarker discovery and validation and of the challenges and strategies inherent in each phase should improve experimental study design, in turn increasing the efficiency of biomarker development and facilitating the delivery and deployment of novel clinical tests.

Animals↗
PubMed1999

Growth curves and survival characteristics of the animals used in the Biomarkers of Aging Program.

The collaborative Interagency Agreement between the National Center for Toxicological Research (NCTR) and the National Institute on Aging (NIA) was aimed at identifying and validating a panel of biomarkers of aging in rodents in order to rapidly test the efficacy and safety of interventions designed to slow aging. Another aim was to provide a basis for developing biomarkers of aging in humans, using the assumption that biomarkers that were useful across different genotypes and species were sensitive to fundamental processes that would extrapolate to humans. Caloric restriction (CR), the only intervention that consistently extends both mean and maximal life span in a variety of species, was used to provide a model with extended life span. C57BI/6NNia, DBA/2JNia, B6D2F1, and B6C3F1 mice and Brown Norway (BN/RijNia), Fischer (F344/NNia) and Fischer x Brown Norway hybrid (F344 x BN F1) rats were bred and maintained on study. NCTR generated data from over 60,000 individually housed animals of the seven different genotypes and both sexes, approximately half ad libitum (AL) fed, the remainder CR. Approximately half the animals were shipped to offsite NIA investigators internationally, with the majority of the remainder maintained at NCTR until they died. The collaboration supplied a choice of healthy, long-lived rodent models to investigators, while allowing for the development of some of the most definitive information on life span, food consumption, and growth characteristics in these genotypes under diverse feeding paradigms.

Aging↗
PubMed2005

Liquid-based cytology for cervical cancer screening.

In multiple studies during the last decade, liquid-based cytology for cervical cancer screening has been shown to increase the detection rate for preneoplastic squamous intraepithelial lesions equal to or greater than the conventional Papanicolaou (Pap) smear method. Liquid-based collection and processing provide more representative cervical sampling than conventional smearing of the specimen on a glass slide. Currently, there are two test methodologies that are widely marketed and available to clinical laboratories, health systems and clinicians that undertake cervical cytology. The purpose of this article is to provide an overview of the methodology and performance of SurePath Liquid-Based Pap Test in cervical cytology screening. The SurePath liquid-based Pap test significantly reduces the unsatisfactory rate of Pap test slides, and detects a significantly higher number of low- and high-grade squamous lesions when compared with the conventional Pap smear technique. Biopsy confirmation shows that this increased detection does not come at a cost of decreasing specificity, and sensitivity for histologic dysplasia is equal to or greater than the best available data for the conventional Pap method. The SurePath collection vial provides residual cellular material for adjunctive out-of-the-vial molecular testing, including sexually transmitted diseases and oncologic biomarkers associated with cervical carcinoma. Finally, SurePath slides can be placed on an automated cervical cytology screening device (FocalPoint), thus providing improved disease detection and enhanced laboratory productivity.

Biopsy↗
PubMed2004

Serum levels of thiobarbituric acid reactive substances predict cardiovascular events in patients with stable coronary artery disease: a longitudinal analysis of the PREVENT study.

OBJECTIVES: The objective of this study was to test the predictive value of an oxidative stress biomarker in 634 patients from the Prospective Randomized Evaluation of the Vascular Effects of Norvasc Trial (PREVENT). BACKGROUND: Oxidative stress contributes to mechanisms of atherosclerosis and plaque instability. Biomarkers of oxidation, such as malondialdehyde (MDA), may represent independent indicators of risk for patients with stable coronary artery disease (CAD). METHODS: Serum MDA levels were measured as thiobarbituric acid reactive substances (TBARS) in 634 patients with documented CAD using reverse-phase high-performance liquid chromatography and spectrophotometric approaches. RESULTS: During the three-year study, there were 51 major vascular events such as fatal/nonfatal myocardial infarction, 149 hospitalizations for nonfatal vascular events, and 139 patients underwent a major vascular procedure. At baseline, patients with TBARS levels in the highest quartile had a relative risk (RR) of 3.30 (95% confidence interval [CI] 1.47 to 7.42; p = 0.038) for major vascular events, RR of 4.10 (95% CI 2.55 to 6.60; p < 0.0001) for nonfatal vascular events, and RR of 3.84 (95% CI 2.56 to 5.76; p < 0.0001) for major vascular procedures. The effect of TBARS on events and procedures was also seen in a multivariate model adjusted for inflammatory markers (C-reactive protein, soluble intercellular adhesion molecule-1, interleukin-6), and other risk factors (age, low-density lipoprotein, high-density lipoprotein, total cholesterol, triglycerides, body mass index, and blood pressure). This analysis showed an independent effect of TBARS on major vascular events (p = 0.0149), nonfatal vascular events (p < 0.0001), major vascular procedures (p < 0.001), and all vascular events and procedures (p < 0.0001). CONCLUSIONS: Serum levels of TBARS were strongly predictive of cardiovascular events in patients with stable CAD, independently of traditional risk factors and inflammatory markers.

Adult↗
PubMed2003

Hypercoagulable states and central retinal vein occlusion.

Central retinal vein occlusion is a common cause of permanent visual loss. Work up and laboratory evaluation of patients requires the clinician to rule out hypertension, diabetes, hyperlipidemia, and glaucoma. Patients without an identifiable risk factor are often subject to extensive testing for primary and secondary thrombophilias. The purpose this paper is to review the literature to determine which of these tests is associated with central retinal vein occlusion. Antiphospholipid antibodies and elevated plasma homocysteine levels appear to be the tests associated most commonly in patients with central retinal vein occlusion in most controlled studies. Primary thrombophilias are found rarely when screening patients with central retinal vein occlusion. Extensive testing for thrombophilias is not warranted in the vast majority of patients with central retinal vein occlusion. Older patients with any of the common vascular risk factors do not require thrombophilic screening. By carefully selecting the patients who are evaluated for thrombophilias, the likelihood of finding true-positive tests is increased.

Biomarkers↗
PubMed2006

Development and characterization of dried blood spot materials for the measurement of immunoreactive trypsinogen.

OBJECTIVES: In response to increasing numbers of states in the US that test newborn babies for cystic fibrosis (CF), the Newborn Screening Quality Assurance Programme initiated a pilot proficiency testing programme for immunoreactive trypsinogen (IRT), the biomarker for CF. Dried blood spot specimens (DBS) were used to evaluate the performance of laboratories that screen babies for CF. METHODS: DBS were prepared from human whole blood enriched with physiologically relevant levels of IRT. Various methods of making IRT-enriched DBS were used to optimize the recovery and stability of the biomarker, including preparation of DBS from either intact or lysed red blood cells, varying the timing of IRT addition to blood before dispensing onto filter paper, adding a protease inhibitor cocktail, and treating serum with charcoal before IRT enrichment. The recovery and stability of IRT in DBS were assessed. Newborn screening laboratories were offered the opportunity to test blind-coded DBS in the pilot PT programme. RESULTS: IRT was stable in the filter paper matrix when stored for one year at either -20 degrees C or 4 degrees C. Fifty percent more IRT was recovered from DBS prepared with lysed red blood cells where the IRT was added to blood just before dispensing; however, protease inhibitors did not improve IRT recovery. CONCLUSIONS: IRT in the DBS matrix is stable and can be shipped worldwide under ambient conditions. Optimal IRT recovery was achieved by adjustment of DBS production practices. Laboratories receiving specimens accurately measured IRT by a variety of commercial and in-house methods.

Charcoal↗
PubMed1996

Porphyrin enzyme analysis in an oral pathology practice: a look back over four years.

The porphyrias are defined by specific enzymes having diminished activity. More enzymes have become available for routine testing. Measurement of urine and stool porphyrin and porphyrin precursor elevations are important, but in many instances are not found or found in confusing patterns. The use of enzyme analysis can often be helpful in identifying those patients with a genetically diminished enzyme activity level. Looking back over the last four years, modifications in evaluating patients for porphyria were developed and are related in this article. In 91 patients, patterns of enzyme deficiencies were seen that have been observed by others; however, new observations have been made. While many of the enzymes in the porphyrin pathway are available for testing, others need to come on line as soon as possible, particularly protoporphyrinogen oxidase.

Adolescent↗
PubMed2024

Stroke genetics and how it Informs novel drug discovery.

INTRODUCTION: Stroke is one of the main causes of death and disability worldwide. Nevertheless, despite the global burden of this disease, our understanding is limited and there is still a lack of highly efficient etiopathology-based treatment. It is partly due to the complexity and heterogenicity of the disease. It is estimated that around one-third of ischemic stroke is heritable, emphasizing the importance of genetic factors identification and targeting for therapeutic purposes. AREAS COVERED: In this review, the authors provide an overview of the current knowledge of stroke genetics and its value in diagnostics, personalized treatment, and prognostication. EXPERT OPINION: As the scale of genetic testing increases and the cost decreases, integration of genetic data into clinical practice is inevitable, enabling assessing individual risk, providing personalized prognostic models and identifying new therapeutic targets and biomarkers. Although expanding stroke genetics data provides different diagnostics and treatment perspectives, there are some limitations and challenges to face. One of them is the threat of health disparities as non-European populations are underrepresented in genetic datasets. Finally, a deeper understanding of underlying mechanisms of potential targets is still lacking, delaying the application of novel therapies into routine clinical practice.

Humans↗