Her2/neu Gastric cancer
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.
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 in which overexpression bodes poor prognosis in untreated gastric and gastroesophageal junction (GEJ) adenocarcinomas. The Her2/neu Pathway IHC assay identifies tumors with HER2 overexpression that might respond to HER2 targeted therapy with trastuzumab.
Requisition Forms
Immunohistochemistry Requisition
A series of immunohistochemistry (IHC) tests used for detai…
Oncology Pathology Requisition
A set of pathology tests designed for cancer diagnostics, i…
Specimen Requirements
Specimen Requirements
- Fresh Tissues: Fixative should be at a 20:1 fixative to tissue ratio, 10% neutral buffered formalin (NBF) for 6-72 hours (48-72 hours PREFERRED)
- Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): FFPE Block, Formalin Fixed
- Unstained slides: 2 slides (3-5 μM) per stain (min 1 slide per stain), Formalin 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.