Intended Use: ERBB2 (HER2/neu) gene amplification
Amplification or over-expression of the ERBB2 (HER2/NEU) gene occurs in approximately 15-30% of breast cancers. It is strongly associated with increased disease recurrence and a poor prognosis. Over-expression is also known to occur in ovarian, stomach, and aggressive forms of uterine cancer, such as uterine serous endometrial carcinoma.
Specimen Required
Paraffin-embed tissue (3–4-micron thick sections in positively charged/silanized slides).
Patient Preparation
- Sample collection: Tumor tissue (FFPE tissue block). Submit block/slides along with the corresponding Histopathology Report.
- Specimen preparation: Formalin fix (10 percent neutral buffered formalin) and paraffin-embed tissue (3–4-micron thick sections). Fixative duration: 6-48 hours.
- Storage/Transport Temperature: Room temperature. Protect paraffin block from excessive heat. Also acceptable: Refrigerated. Ship in cooled container during summer months.
- Unacceptable Conditions: Paraffin block with no tumor tissue remaining. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens. Specimens with fixation delayed for more than one hour. Tissue fixed or less than 6 hours of greater than 48 hours.
- Remarks
- Stability: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Methodology
Fluorescence in situ Hybridization (FISH)
Sample received to report Turnaround time (TAT)
5 working days
Reference Interval
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Interpretive Data
The most recent ASCO/CAP interpretation criteria for evaluating ERBB2 (HER2/neu) gene amplification status is used.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report