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Glossary
Pages 73-76

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From page 73...
... Clinical validity – the accuracy of a test for a specific clinical purpose, such as diagnosing or predicting risk for a disorder. Companion Diagnostic Test – in this report, companion diagnostic tests include tests that are predictive of a therapeutic response that have gone through the FDA approval process.
From page 74...
... Several new drugs recently approved by the Food and Drug Administration specifically target EGFR. Genomics – the study of all of the nucleotide sequences, including structural genes, regulatory sequences, and noncoding DNA segments, in the chromosomes of an organism or tissue sample.
From page 75...
... The Food and Drug Administration generally requires new drugs to be tested in Phase III trials before they can be put on the market. Predictive tests – in this report, tests that are predictive of a therapeutic response are referred to as "predictive tests." Premarket approval – a Food and Drug Administration approval for a new test or device that enables it to be marketed for clinical use.
From page 76...
... Trastuzumab – see Human epidermal growth factor receptor 2. validation – the process of assessing the assay or measurement performance characteristics.


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