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HER-2 Immunohistochemistry (IHC), Breast With Reflex to FISH if 0, 1+, or 2+ by IHC
Tissues are evaluated by immunohistochemistry. Specimens demonstrating 0, 1+ (mild) or 2+ (moderate) staining for the HER-2/neu protein are evaluated for gene amplification status by FISH. In such cases, FISH provides a better indication of potential response to therapy. (See also reflex testing for IHC results of 2+ .)
Use of fixatives other than 10% neutral-buffered formalin or fixation times less than six hours or more than 48 hours may not yield equivalent or satisfactory results.
Tumor (formalin-fixed, paraffin-embedded)
One paraffin block
Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between six 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
Tumor other than breast tumor
Please direct any questions regarding this test to oncology customer service at 800-345-4363.
Note: Per client request, the IHC will reflex to FISH if the result is 0, 1+ or 2+.