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Activity Number:
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329
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #309819 |
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Title:
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Multivariate Assays Reporting a Composite Score
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Author(s):
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Estelle Russek-Cohen*+ and Mary Pastel and Zivana Tezek
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Companies:
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Food and Drug Administration and Food and Drug Administration and Food and Drug Administration
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Address:
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1350 Piccard Dr, CDRH, Rockville, MD, 20850,
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Keywords:
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In vitro diagnostics ; medical devices ; microarrays
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Abstract:
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With the rise of genomic and proteomic technologies, one would expect to see medical devices that combine the results of multiple probes, analytes or biomarkers into a single result or score that is then interpreted. These assays need to be sufficiently robust that they can be performed over long time periods and in multiple labs and still be reproducible. This talk will include a discussion of how performance in these in vitro devices could be measured, whether a device is associated with a diagnostic or prognostic intended use. The role of an external validation dataset will also be covered.
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