Evolution of Translational Omics Lessons Learned and the Path Forward (2012) / Chapter Skim
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Appendix C: Introduction to Biomarkers
Appendix C: Introduction to Biomarkers
Pages 281-288
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report on Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease provided the following description of biomarkers (IOM, 2010) : Biomarkers can be measurements of macromolecules (DNA, RNA, proteins, lipids)
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Although these uses are applicable to most if not all disease processes, this appendix refers to oncologic examples because most of the case studies for this report arose from the field of oncology. Prognostic Factors and Effect Modifiers1 Prognostic Factors Prognostic factors, used to estimate the risk of or time to clinical outcomes such as disease recurrence or progression, may be useful even though these biomarkers are simply correlated with the causal mechanisms of the disease process (Fleming, 2005)
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From page 283... ...
For example, if the level of a tumor biomarker in the bloodstream is rising in a patient with previously established cancer, that may be an indication of an impending relapse, and might guide earlier intervention than if the clinician waits for the relapse to be detectable by other means. Such a surrogate endpoint may have clinical/biological validity but may or may not have clinical utility.
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Risk assessment is particularly valuable if preventive measures and/or early detection and intervention have been shown to effectively reduce morbidity or mortality. For example, prophylactic surgery and/or chemoprevention with the selective estrogen receptor modulators (SERMs; tamoxifen, raloxifene)
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Pharmacogenetics In many diseases, inherited germline DNA sequence variants, known as single nucleotide polymorphisms (SNPs) , may determine individual differences in drug distribution within the body, metabolism, or effect on target tissues.
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Technologies Enabling Omics Research Technologies enabling omics research include gene expression microarrays, multiplex quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) , sequence analysis of DNA, RNA, and proteins, and multiple mass spectrometry techniques.
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2009. American Society of Clinical Oncology provisional clinical opinion: Testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy.
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2007. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer.
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