HER2/neu Gastric Cancer, paraffin
Companion Diagnostic
HER2/neu Gastric Cancer, paraffin is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
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.
Special Instructions
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.
Limitations
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.
FDA ApprovedCompanion Diagnostic
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
ERBB2
Gene
Result Turnaround Time
5 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen. Do not freeze.
Storage Instructions
15°C to 25°C
Causes for Rejection
Improper fixative; Tissue not fixed; Insufficient tissue; Specimen exposed to extreme temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Stable indefinitely |