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HER2 neu

Test ID: I HER2 CPT Code: 88360
Expected Turnaround Time
2 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Clinical Information
HER2 is a membrane receptor tyrosine kinase expressed in breast cells. HER2 amplification is observed in malignant transformation and tumor progression in a fraction of patients with breast cancer. The Pathway Her-2/neu IHC assay is a companion diagnostic used to identify patients who are eligible for treatment with HERCEPTIN, KADCYLA, or ENHERTU.
Requisition Forms
Immunohistochemistry Requisition

A series of immunohistochemistry (IHC) tests used for detai…

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Oncology Pathology Requisition

A set of pathology tests designed for cancer diagnostics, i…

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Specimen Requirements

Specimen Requirements
  • Fresh Tissue Biopsies and resections: Fixative should be at a 20:1 fixative to tissue ratio, 10% neutral buffered formalin (NBF) for 6-72 hours (48-72 hours PREFERRED)
  • Paraffin Embedded Tissue FFPE Block: 10% NBF Fixed
  • Paraffin Embedded Tissue Slides: 2 slides (3-5 μM) per stain (1 slide per stain minimum), 10% NBF Fixed
Specimen Stability
  • Fresh Tissue Tissues: ≤ 72 Hours
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): Indefinite
  • Unstained slides: Indefinite
Storage Requirements

15°C to 25°C

Shipping Conditions
Ambient
Shipping Recommendations
  • Fresh Tissues: AMBIENT
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks) and unstained slides: AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.
  • Specimens may be transferred to 70% alcohol for transportation purposes after fixation in 10% NBF or B plus.
Specimen Rejection Criteria

Specimens must be fixed in 10% NBF or B plus. All other fixatives will be rejected. 

Test Details

Synonyms

Anti-HER-2/neu (4B5), Human Epidermal Growth Factor Receptor, Receptor tyrosine-protein kinase 2, ErbB2, ERBB2, p185, C-erb-2, MLN-19, HER-2, CD340, Metastatic lymph node gene 19 protein, p185erbB2, C-Erb B2/Neu

Test Method
Immunohistochemistry
Methodology Category
IHC
Regulatory Status
FDA-Approved Companion Diagnostic (CDx), IVD, CE-marked
Special Considerations
  • Fresh Tissue Biopsies and resections: Specimens should be immersed in fixative within one hour of the biopsy or resection. The time of immersion of the tissue in fixative should be recorded and submitted to the laboratory.
  • Paraffin Embedded Tissue FFPE Block: Total fixation time must be noted. FFPE block or fresh tissue preferred.
  • Unstained Paraffin Embedded Tissue Slides: Positively charged glass slides required to prevent background staining and prevent tissue loss. Slides should be left unbaked.