Tumour markers: their use and misuse by clinicians

PJ McGinley, ES Kilpatrick - Annals of clinical biochemistry, 2003 - journals.sagepub.com
Background: Several guidelines exist on the appropriate use of serum tumour markers in the
management of patients with cancer. This study audited tumour marker requesting against …

Validation of analytic methods for biomarkers used in drug development

CH Chau, O Rixe, H McLeod, WD Figg - Clinical Cancer Research, 2008 - AACR
The role of biomarkers in drug discovery and development has gained precedence over the
years. As biomarkers become integrated into drug development and clinical trials, quality …

Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis

JW Lee, M Hall - Journal of Chromatography B, 2009 - Elsevier
Protein biomarkers are used for various purposes in drug development and clinical
diagnosis and prognosis. In this review, a fit-for-purpose method validation approach is …

Statistical issues in tumor marker studies

TF Pajak, GM Clark, DJ Sargent… - … of pathology & …, 2000 - meridian.allenpress.com
Context.—Inferences from tumor marker studies are complicated by a variety of statistical
concerns, which can make proper interpretation of results difficult. This article focuses on …

Can molecular markers now be used for early diagnosis of malignancy?

MJ Duffy - Clinical chemistry, 1995 - academic.oup.com
Most of the presently available cancer markers are neither specific for malignancy nor allow
early diagnosis. However, the recent elucidation of the molecular events occurring during …

A consortium for analytic standardization in immunohistochemistry

SA Bogen, DJ Dabbs, KD Miller… - … of pathology & …, 2023 - meridian.allenpress.com
Context.—The authors announce the launch of the Consortium for Analytic Standardization
in Immunohistochemistry, funded with a grant from the National Cancer Institute. As with …

Principles of analytic validation of immunohistochemical assays: guideline from the College of American Pathologists Pathology and Laboratory Quality Center

PL Fitzgibbons, LA Bradley… - … of Pathology and …, 2014 - meridian.allenpress.com
Context Laboratories must validate all assays before they can be used to test patient
specimens, but currently there are no evidence-based guidelines regarding validation of …

Kinetics of serum tumor marker concentrations and usefulness in clinical monitoring

JM Bidart, F Thuillier, C Augereau, J Chalas… - Clinical …, 1999 - academic.oup.com
Only a few markers have been instrumental in the diagnosis of cancer. In contrast, tumor
markers play a critical role in the monitoring of patients. The patient's clinical status and …

Early detection of cancer: immunoassays for plasma tumor markers

DL Meany, LJ Sokoll, DW Chan - Expert opinion on medical …, 2009 - Taylor & Francis
Background: Plasma tumor biomarkers are widely used clinically for monitoring response to
therapy and detecting cancer recurrence. Only a limited number of them, however, have …

Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics

H Rodriguez, Z Tezak, M Mesri, SA Carr… - Clinical …, 2010 - academic.oup.com
Clinical proteomics has the potential to enable the early detection of cancer through the
development of multiplex assays that can inform clinical decisions. However, there has been …