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HER-2/CEP17, FISH With Reflex to HERmark® if FISH Equivocal
- HERmark® Reflex
Qualitative determination of HER-2/neu gene amplification; prognostic information regarding risk of recurrence and disease-related death; predict response to therapies, including targeted immunotherapies
Use of fixatives other than 10% formalin, fixation times less than 6 hours or greater than 48 hours may not yield reliable results.
Results of the HER-2/neu 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)
Tumor (formalin-fixed, paraffin-embedded)
One paraffin block or eight 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
Fixation time and fixative used must be indicated on the test request form.
Please attach pathology report. Direct any questions regarding this test to oncology customer service at 800-345-4363.