HER2/neu Gastric Cancer, paraffin
Expected Turnaround Time
5 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
FISH testing on paraffin-embedded cells for detection of HER2/neu (ERBB2; 17q12) gene amplification in primary and/or metastatic breast cancer. Patients with HER2 amplification may benefit from treatment with trastuzumab. The FDA-approved PathVysion HER2 assay is available upon request.
Requisition Forms
Specimen Requirements
Specimen Requirements
- FFPE Tissue Block
- Unstained FFPE tissue: 5 slides preferred (3 slides minimum) cut at 3-5 μM and mounted on positively charged slides.
Specimen Stability
Stable indefinitely
Storage Requirements
15°C to 25°C
Shipping Conditions
Ambient
Shipping Recommendations
AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen. Do not freeze.
Specimen Rejection Criteria
Improper fixative; Tissue not fixed; Insufficient tissue; Specimen exposed to extreme temperature
Test Details
Synonyms
Gastric HER2/neu, CEP 17,17q11.2q12 amplification
Keywords
Companion Diagnostics, Fluorescence in-situ Hybridization, Oncology, Oncology FISH Probes, Gastrointestinal Cancer, Genomics
Test Method
Fluorescence in situ hybridization (FISH)
Methodology Category
FISH
Regulatory Status
ASR, FDA-Approved Companion Diagnostic (CDx), IVD
Special Considerations
Tissues should be fixed in 10% neutral buffered formalin (NBF). Tissues preserved in B+ fixative or decalcified are usually not suitable for FISH. Assay requires 3 unstained slides minimum (two for each probe) and one H&E stained slide. If unstained slides are sent, cut FFPE tissue sections at 3-5 μm thickness, mounted on positively charged slides.
Associations
Gastric and gastroesophageal junction (GEJC) cancer;
Herceptin