FISH, HER-2/neu, Paraffin Block
Also known as: Breast cancer, HER2 IQFISH pharmDx, Her-2/neu, c-erbB2, ERBB2
Use
HER‑2 oncogene amplification in stage 2 lymph node‑positive breast cancer, which aids in treatment selection and prognostication. Identifies HER‑2 gene amplification in invasive primary or metastatic breast or gastric cancer. Helps guide Herceptin (trastuzumab) therapy decisions.
Special Instructions
Pathology report must accompany paraffin block or slides. Specimen must be fixed in 10% neutral buffered formalin with cold ischemic time <1 hour and fixation 6‑72 hours. Specimen may be paraffin‑embedded tissue block or unstained sections on charged slides. Ship at room temperature. Do not freeze.
Limitations
The analytical performance characteristics were determined by Quest Diagnostics; modifications have not been cleared or approved by FDA. Validated pursuant to CLIA regulations.
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
Result Turnaround Time
4 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
5 micron (minimum 4 micron) sections collected on each of (x6) positively charged slides
Collection Instructions
Invasive primary or metastatic breast or gastric cancer formalin‑fixed, paraffin‑embedded tissue or charged/+slides. Fix in 10% neutral buffered formalin, cold ischemic time <1 hour, fixation 6‑72 hours. Pathology report must accompany specimen.
Storage Instructions
Ship at room temperature; Do Not Freeze.
Causes for Rejection
Non‑invasive tumors; unfixed or improperly fixed tissue; freezing
Stability Requirements
| Temperature | Period |
|---|---|
| Frozen | Unacceptable |