Alternative Name
HER2 neu
Methodology
FISH
Test Description
Probes: HER2 (17q11.2-q12) | Centromere 17 (Cen 17)
Disease(s): Gastric cancer, Gastroesophageal Adenocarcinoma, Gastroesophageal junction (GEJ) cancer
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 with gastric cancer. Scoring for HER2 is performed according to 2016 CAP/ASCP/ACSO consensus guidelines for gastric/gastroesophageal adenocarcinoma.
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™). Client Services will call your office or lab for missing IHC reports.
- 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