Alternative Name
HER2 neu
Methodology
FISH
Test Description
Probes: HER2 (17q11.2-q12) | Centromere 17 (Cen 17)
Disease(s): Endometrial cancer, salivary duct carcinoma, ovarian cancer, serous carcinomas, and other various tumor types
Clinical Significance
HER2, a member of the epidermal growth factor receptor family, is a transmembrane protein with tyrosine kinase activity. Gene amplification and protein overexpression of HER2 have been found in a variety of tumors. This test provides HER2 amplification status to aid in determining anti-HER2 targeted therapies for patients. Scoring is performed using the following:
- HER2 (Other) with Breast scoring uses the 2018 CAP/ASCO guidelines for breast cancer for HER2 evaluation. Breast scoring is recommended for indications such as endometrium cancer, salivary duct carcinoma, serous carcinoma, and ovarian cancer as well as other clinical indications without consensus guidelines.
- HER2 (Other) with Gastric scoring uses the 2016 CAP/ASCP/ASCO consensus guidelines for gastric/gastroesophageal adenocarcinoma for HER2 evaluation.
Specimen Requirements
- Pathology Report: For global HER2 FISH cases we require a copy of the HER2 IHC pathology report (if it is not available to us in NeoLINK™). For HER2 (Other) with Breast Scoring, the HER2 IHC slide may also be required for intrepation of results. Client Services will call your office or lab for missing IHC reports or to request slides.
- Bone Marrow Aspirate: N/A
- Peripheral Blood: N/A
- Fresh, Unfixed Tissue: N/A
- Fluids: N/A
- Paraffin Block: H&E slide (required) plus paraffin block. Circle H&E for tech-only.
- Cut Slides: H&E slide (required) plus 2 unstained slides cut at 4 microns.Circle H&E for tech only.
Storage & Transportation
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
CPT Code(s)*
88374x1 automated. Codes may differ if manual analysis is performed.
Turnaround Time
3-5 Days
Level of Service
Global
Technical
New York Approved
Yes
References
- Bartley AN, Washington MK, Ventura CB, et al. HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology. Arch Pathol Lab Med. 2016;140(12):1345-1363. doi:10.5858/arpa.2016-0331-CP
- Cancer Protocol Templates- Biomarker Reporting. College of American Pathologists. https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates. Accessed November 24, 2020.
- Wolff AC, Hammond MEH, Allison KH, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. Arch Pathol Lab Med. 2018;142(11):1364-1382. doi:10.5858/arpa.2018-0902-SA