Cancer Biomarker Validation: Standards and Process

Barker, Peter E.

doi:10.1111/j.1749-6632.2003.tb05969.x

Cited by 50 publications

(13 citation statements)

References 14 publications

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“…In contrast, in early disease, the biological distinctions between healthy and disease states or alternative diagnosis are often more subtle, and clear differentiation even for a gold standard becomes more challenging. Therefore, the evaluation of a candidate diagnostic biomarker requires an infallible diagnosis to be established which in RA remains difficult [215]. …”

Section: Cytokines Network In Ramentioning

confidence: 99%

Cytokines as Biomarkers in Rheumatoid Arthritis

Burska

Boissinot

Ponchel

2014

Mediators of Inflammation

179

139

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RA is a complex disease that develops as a series of events often referred to as disease continuum. RA would benefit from novel biomarker development for diagnosis where new biomarkers are still needed (even if progresses have been made with the inclusion of ACPA into the ACR/EULAR 2010 diagnostic criteria) and for prognostic notably in at risk of evolution patients with autoantibody-positive arthralgia. Risk biomarkers for rapid evolution or cardiovascular complications are also highly desirable. Monitoring biomarkers would be useful in predicting relapse. Finally, predictive biomarkers for therapy outcome would allow tailoring therapy to the individual. Increasing numbers of cytokines have been involved in RA pathology. Many have the potential as biomarkers in RA especially as their clinical utility is already established in other diseases and could be easily transferable to rheumatology. We will review the current knowledge's relation to cytokine used as biomarker in RA. However, given the complexity and heterogeneous nature of RA, it is unlikely that a single cytokine may provide sufficient discrimination; therefore multiple biomarker signatures may represent more realistic approach for the future of personalised medicine in RA.

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Section: Cytokines Network In Ramentioning

confidence: 99%

Cytokines as Biomarkers in Rheumatoid Arthritis

Burska

Boissinot

Ponchel

2014

Mediators of Inflammation

179

139

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“…Defined mixtures of control proteins and protein solubility at high concentrations may be problematic for multiplexed assays (47). These issues are receiving attention from agencies, such as the National Institute of Standards and Technology, that produce and distribute standard reference materials for clinical applications (48). …”

Section: Operational Controlmentioning

confidence: 99%

Antibody-Based Protein Multiplex Platforms: Technical and Operational Challenges

Ellington

Kullo²,

Bailey³

et al. 2010

Clinical Chemistry

278

241

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BACKGROUND:The measurement of multiple protein biomarkers may refine risk stratification in clinical settings. This concept has stimulated development of multiplexed immunoassay platforms that provide multiple, parallel protein measurements on the same specimen. CONTENT:We provide an overview of antibody-based multiplexed immunoassay platforms and discuss technical and operational challenges. Multiplexed immunoassays use traditional immunoassay principles in which high-affinity capture ligands are immobilized in parallel arrays in either planar format or on microspheres in suspension. Development of multiplexed immunoassays requires rigorous validation of assay configuration and analytical performance to minimize assay imprecision and inaccuracy. Challenges associated with multiplex configuration include selection and immobilization of capture ligands, calibration, interference between antibodies and proteins and assay diluents, and compatibility of assay limits of quantification. We discuss potential solutions to these challenges. Criteria for assessing analytical multiplex assay performance include the range of linearity, analytical specificity, recovery, and comparison to a quality reference method. Quality control materials are not well developed for multiplexed protein immunoassays, and algorithms for interpreting multiplex quality control data are needed.

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“…Validation of cancer biomarkers is complex and must be thorough if the marker is to be used in patient care 4-6. The aim of this comprehensive review was to identify important biomarkers associated with DCIS and candidate biomarkers associated with increased risk of ipsilateral recurrence after diagnosis of DCIS.…”

Section: Introductionmentioning

confidence: 99%

Biological Markers in DCIS and Risk of Breast Recurrence: A Systematic Review

2011

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Understanding of the biology and clinical behavior of ductal carcinoma in situ (DCIS) is currently inadequate. The aim of this comprehensive review was to identify important molecular biological markers associated with DCIS and candidate markers associated with increased risk of ipsilateral recurrence after diagnosis of DCIS. A comprehensive systematic review was performed to identify studies published in the past 10 years that investigated biological markers in DCIS. To be included in this review, studies that investigated the rate of biological expression of markers had to report on at least 30 patients; studies that analyzed the recurrence risk associated with biomarker expression had to report on at least 50 patients. There were 6,252 patients altogether in our review. Biological markers evaluated included steroid receptors, proliferation markers, cell cycle regulation and apoptotic markers, angiogenesis-related proteins, epidermal growth factor receptor family receptors, extracellular matrix-related proteins, and COX-2. Although the studies in this review provide valuable preliminary information regarding the expression and prognostic significance of biomarkers in DCIS, common limitations of published studies (case-series, cohort, and case-control studies) were that they were limited to small patient cohorts in which the extent of surgery and use of radiotherapy or endocrine therapy varied from patient to patient, and variable methods of determining biomarker expression. These constraints made it difficult to interpret the absolute effect of expression of various biomarkers on risk of local recurrence. No prospective validation studies were identified. As the study of biomarkers are in their relative infancy in DCIS compared with invasive breast cancer, key significant prognostic and predictive markers associated with invasive breast cancer have not been adequately studied in DCIS. There is a critical need for prospective analyses of novel and other known breast cancer molecular markers in large cohorts of patient with DCIS to differentiate indolent from aggressive DCIS and better tailor the need and extent of current therapies.

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Cancer Biomarker Validation: Standards and Process

Cited by 50 publications

References 14 publications

Cytokines as Biomarkers in Rheumatoid Arthritis

Cytokines as Biomarkers in Rheumatoid Arthritis

Antibody-Based Protein Multiplex Platforms: Technical and Operational Challenges

Biological Markers in DCIS and Risk of Breast Recurrence: A Systematic Review

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