2 - 4 days
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. This IHC test is indicated for identifying breast cancer patients who are eligible for treatment with Herceptin® (IHC 3+ or IHC 2+/ISH amplified), KADCYLA® (IHC 3+ or IHC 2+/ISH amplified) or ENHERTU® (HER2-low: IHC 1+ or IHC 2+/ISH non-amplified).
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.
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.
Modi S, et al. DESTINY-Breast04 Trial Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. doi: 10.1056/
NEJMoa2203690. Epub 2022 Jun 5. PMID: 35665782.
PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody [package insert]. Tucson, AZ: Roche Ventana; 2022.
Wolff AC, Hammond EH, et al: Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: ASCO/CAP Clinical Practice Guideline Focused Update. J Clin Oncol: 36:2105-2122, July 10, 2018.
Information on collection, storage, and volume
Formalin-fixed, paraffin-embedded (FFPE) tumor
One paraffin block or seven unstained, positively-charged air-dried and unbaked slides cut at 4 to 5 microns. This includes specimen requirements for FISH reflex.
Paraffin block transport pouch or slide mailer
Maintain specimen at room temperature.
Tumor other than breast tumor
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.
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