Author: | Rai, A. J. |
Article Title: | Biomarkers in translational research: Focus on discovery, development and translation of protein biomarkers to clinical immunoassays |
Abstract: | The field of biomarker discovery has exhibited a great surge of interest in recent years. Biomarkers can be used for many purposes including diagnosis, prognosis and selecting appropriate patient therapy, and can provide information on disease mechanism or progression. Translation of such markers to clinical testing encompasses phases for their discovery and characterization, assay development, and finally, implementation using automated platforms employed in clinical laboratories. With a focus on protein-based biomarkers and clinical immunoassays, the three phases are discussed in greater detail. The currently used technologies in the clinical laboratory are described, including attributes of existing immunoassay types, and some recent advances in methods development for multiplexed immnuoassays. Finally, regulatory considerations that need to be addressed before a biomarker assay is commercialized are discussed briefly. © 2007 Future Drugs Ltd. |
Keywords: | genetics; disease course; review; nonhuman; methodology; sensitivity and specificity; neoplasm; neoplasms; quantitative assay; reproducibility; proteins; biological marker; protein analysis; biological markers; blood proteins; reproducibility of results; protein targeting; tumor markers, biological; protein; high throughput screening; tumor marker; blood; protein synthesis; biomarker; recombinant protein; clinical research; protein biosynthesis; immunoassay; antibodies; clinical laboratory; antibody; enzyme assay; electrophoresis; plasma protein; translational research; photometry; antigen antibody complex; translation regulation; antigen antibody reaction; polyclonal antibody; spectrophotometry; assay development; clinical laboratory testing; nephelometry; turbidimetry; antigen-antibody complex |
Journal Title: | Expert Review of Molecular Diagnostics |
Volume: | 7 |
Issue: | 5 |
ISSN: | 1473-7159 |
Publisher: | Informa Healthcare |
Date Published: | 2007-09-01 |
Start Page: | 545 |
End Page: | 553 |
Language: | English |
DOI: | 10.1586/14737159.7.5.545 |
PUBMED: | 17892363 |
PROVIDER: | scopus |
DOI/URL: | |
Notes: | --- - "Cited By (since 1996): 8" - "Export Date: 17 November 2011" - "CODEN: ERMDC" - "Source: Scopus" |