HER2/neu Breast Cancer, paraffin
Companion Diagnostic
HER2/neu Breast 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. HER2-positive tumors have shown to benefit from Herceptin treatment. Current recommendations for HER2 testing include using FISH as a follow up for all IHC 2+ cases.
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
Improper fixation of tissue could affect the accuracy of the test. Tissues preserved in B+ fixative or decalcified are usually not suitable for FISH. Insufficient tissue, specimen exposed to extreme temperature, or tissue not fixed properly leads to specimen rejection.
FDA ApprovedCompanion Diagnostic
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
Result Turnaround Time
5 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
3 slides minimum
Container
Positively charged slides
Collection Instructions
Cut FFPE tissue sections at 3-5 μm thickness, mounted on positively charged slides.
Patient Preparation
Tissues should be fixed in 10% neutral buffered formalin (NBF).
Storage Instructions
Store at 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 |