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Abstract Details
Activity Number:
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457
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #301472 |
Title:
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Individualized Disease Diagnostics: Improving Diagnostic Tests with Genomic/Genetic/Clinical Information
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Author(s):
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Meijuan Li*+
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Companies:
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U.S. Food and Drug Administration/CDRH
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Address:
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#2225/66, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA
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Keywords:
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Individualized Disease Diagnostics ;
cutoff ;
diagnostics medicine ;
predictive value ;
diagnostic accuracy ;
overdiagnosis and overtreatment
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Abstract:
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A patient's certain clinical or genetic/genomic characteristics may affect his diagnostic test level independent of his disease status. However, a uniform cutoff (i.e. a population based cutoff) regardless of patients' characteristics is often used in diagnostics medicine where a cutoff is defined as the threshold at which the test differentiates a positive from a negative outcome. Consequently, such test can be controversial because of its modest predictive value and diagnostic accuracy; the potential overdiagnosis and overtreatment of the disease. Therefore, using more individualized thresholds based on a test; molecular measures; and patient age, ethnicity, and family history of disease can improve the predictive ability and the accuracy of this test. In this talk, we will discuss issues related to population-based diagnostic approaches and discuss some statistical methods for individualized diagnostic approaches.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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