Journal
PROTEOMICS CLINICAL APPLICATIONS
Volume 2, Issue 10-11, Pages 1378-1385Publisher
WILEY-V C H VERLAG GMBH
DOI: 10.1002/prca.200780170
Keywords
Biomarker development; FDA filing
Funding
- National Cancer Institute, National Institutes of Health [N01-CO-12400]
- NIH, National Cancer Institute, Center for Cancer Research
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With the numerous reports of new technologies and biomarkers reported in the literature, it may be surprising that there are not an equal number of new products available to the clinical diagnostic laboratory. Powerful potential tools such as protein microarrays and MS patterns have been extensively published yet commercialization and acceptance of these technologies has yet to happen. The reasons for this are a combination of industry risk avoidance, academic focus on discovery, and a lack of appreciation for the high standards and regulation that surrounds the clinical diagnostic laboratory. The development and validation of a new technology or biomarker ensures that a test is reproducible, controllable, and has a defined accuracy and clinical predictive result but this information is only obtained through somewhat mundane but necessary experimental work. The use of design of experiment principles helps to define material parameters to ensure performance. The organization and documentation of this work through a quality system is both mandated and practical. All of this must be done before a test can reach the market with the safety and effectiveness review of regulatory agencies.
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