HER2/neu Gastric Cancer, paraffin

Test ID: FP HER2 GA CPT Code: 88377

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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.

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

Oncology Pathology Requisition

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

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