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Qualitative determination of HER-2/neu gene amplification; prognostic information regarding risk of recurrence and disease-related death; predict response to therapies, including targeted immunotherapy
Use of fixatives other than 10% formalin or fixation times less than six hours or more than 48 hours may not yield reliable results.
Results of the HER-2/CEP17 FISH assay should always be used in conjunction with other information available from the clinical evaluation of the patient and other prognostic factors, such as tumor size, histologic grade, nodal status, patient's age, hormone receptor status, and other known risk factors.
Fluorescence in situ hybridization (FISH)
Formalin-fixed, paraffin-embedded (FFPE) tumor (tissue block)
One paraffin block or four unstained, positively-charged tissue slides cut at 4 to 5 microns and dried overnight at 56°C.
Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 72 hours according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18 and 24 hours.
Maintain specimen at room temperature.
Causes for Rejection
Fixative other than neutral buffered formalin; quantity not sufficient for analysis; tumor other than breast tumor
Please direct any questions regarding this test to oncology customer service at 800-345-4363.