Alternative Name
HER2 neu
Methodology
FISH
Test Description
Probes: HER2 (17q11.2-q12) | Centromere 17 (Cen 17)
Disease(s): Colorectal 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 colorectal cancer. Scoring is performed based on clinical guideline and clinical trial recommendations for colorectal cancer.
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 and 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
References
- Hainsworth JD, Meric-Bernstam F, Swanton C, et al. Targeted Therapy for Advanced Solid Tumors on the Basis of Molecular Profiles: Results From MyPathway, an Open-Label, Phase IIa Multiple Basket Study [published correction appears in J Clin Oncol. 2019 Feb 1;37(4):360]. J Clin Oncol. 2018;36(6):536-542. doi:10.1200/JCO.2017.75.3780
- Sartore-Bianchi A, Trusolino L, Martino C, et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial [published correction appears in Lancet Oncol. 2016 Oct;17 (10 ):e420]. Lancet Oncol. 2016;17(6):738-746. doi:10.1016/S1470-2045(16)00150-9
- Valtorta E, Martino C, Sartore-Bianchi A, et al. Assessment of a HER2 scoring system for colorectal cancer: results from a validation study. Mod Pathol. 2015;28(11):1481-1491. doi:10.1038/modpathol.2015.98
New York Approved
Yes
Level of Service
Global
Technical