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The Vysis EGR1 FISH Probe Kit is intended to detect deletion of the LSI EGR1 probe target on chromosome 5q in bone marrow specimens and to be used, in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of acute myeloid leukemia (AML) diagnosis as an aid in determining prognosis. Deletion of chromosome 5q has been associated with an unfavorable prognosis in AML patients. It is intended to be used in combination with additional biomarkers, morphology, and other clinical information.
Cancer:
Acute Myelogenous Leukemia
Gene:
EGR1 (Early Growth Response 1)
Method:
Fluorescence in situ hybridization (FISH)
Approvals
Date
Cancer
Gene
Drug
By
08/29/11
FDA
Confirmatory trial(s)