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The HER-2/neu protein is a product of the HER-2/neu oncogene, and the detection of overexpression of the HER-2/neu protein has been associated in clinical evaluations with a decreased survival time and a decreased time to relapse in patients with breast cancer.1-3 HER-2/neu overexpression is also a predictor of response to certain breast cancer therapies, including targeted immunotherapies.4-6
Use of fixatives other than 10% neutral-buffered formalin or fixation times less than six hours or more than 48 hours may not yield reliable results.
Formalin-fixed, paraffin-embedded (FFPE) tumor
One paraffin block or five unstained, positively-charged tissue slides cut at 4 to 5 microns and dried for one hour at 60°C
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
Fixation time and fixative used must be indicated on the test request form. Please direct any questions regarding this test to oncology customer service at 800-345-4363.
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|480376||HER-2/neu Oncoprot, Paraffin||480449||HER-2/neu (C-erbB-2)||18474-7|
|480376||HER-2/neu Oncoprot, Paraffin||480458||Scoring Guide||19147-8|
|480376||HER-2/neu Oncoprot, Paraffin||480381||Comment||77202-0|
|480376||HER-2/neu Oncoprot, Paraffin||483256||Fixation Time||N/A|
|480376||HER-2/neu Oncoprot, Paraffin||483257||Fixative||N/A|
|480376||HER-2/neu Oncoprot, Paraffin||480233||Director Review||69426-5|