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From genome to bedside: are we lost in translation?
1University of Michigan Comprehensive Cancer Center, 1500 E. Medical Center Drive, Ann Arbor, MI 48109, USA.
Breast (Edinburgh, Scotland)
|October 1, 2013
Summary
Omics technologies characterize biological molecules like DNA and proteins. Rigorous validation is essential for clinical use of omics-based tests in patient care, similar to drug development.
Area of Science:
- Biomarker Discovery
- Translational Science
- Clinical Diagnostics
Background:
- The
Purpose of the Study:
- To outline the Institute of Medicine's roadmap for omics-based test validation.
- To emphasize the necessity of clinical validity and utility for diagnostic tests.
Main Methods:
- Following Institute of Medicine committee guidelines for test development.
- Utilizing prospective retrospective or prospective study designs for validation.
Main Results:
- Omics technologies enable comprehensive characterization of biological molecules.
- A multi-disciplinary approach is crucial for translating omics discoveries into clinical practice.
Conclusions:
- Rigorous scientific validation is paramount for the clinical application of omics-based diagnostic tests.
- The development of diagnostic tests requires a level of scientific rigor comparable to therapeutic agent assessment.
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