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IVD Test Reagent/Kits, Molecular Assay, Gene Expression, Cancer Recurrence

Definition : Gene expression molecular assay reagents intended to determine the level at which certain genes are expressed (i.e., the gene activity) in a cancer tumor tissue. The tissue sample is analyzed to determine the presence or levels of nucleic acids, proteins, and/or other molecular products by one or more of a variety of methods, such as reverse transcription-polymerase chain reaction (RT-PCR), fluorescent in-situ hybridization (FISH), or microarray analysis. The overexpression or underexpression of these genes may be associated with the likelihood of certain cancer patient outcomes. Cancer recurrence gene expression tests are frequently used to obtain a more precise estimate of the risk of disease recurrence; the tests also may be used to determine appropriate (e.g., drug-specific) treatment and/or to identify the tissue of origin for tumors with unclear pathology. Some tests give a recurrence score that predicts the chance of the cancer returning within a given period (e.g., 10 years) of the original diagnosis.

Entry Terms : "Oncotype DX Molecular Assays" , "Cancer Recurrence Oncotype DX Molecular Assays" , "Cancer Recurrence Gene Expression Reagents" , "Reagents, Molecular Assay, Gene Expression, Cancer Recurrence"

UMDC code : 26999

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