HER-2/CEP17, FISH
Use
Qualitative determination of HER-2/neu gene amplification; prognostic information regarding risk of recurrence and disease-related death; predict response to therapies, including targeted immunotherapy
Special Instructions
Please direct any questions regarding this test to oncology customer service at 800-345-4363. Ensure specimens are fixed in 10% neutral-buffered formalin with fixation times between 6 and 72 hours as per ASCO/CAP guidelines, although optimal fixation time is between 18 and 24 hours.
Limitations
The reliability of the HER-2/CEP17 FISH assay may be compromised if non-standard fixatives are used or if fixation times fall outside the 6 to 72-hour range. The results should be integrated with clinical evaluations and other known prognostic factors. The test is not applicable to tumors other than breast tumors, and improper specimen handling can lead to rejection.
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
LOINC Codes
- 31150-6
- 49683-6
- 74860-8
- 74861-6
- 62361-1
- 19147-8
Result Turnaround Time
3-5 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
One paraffin block or four unstained, positively-charged tissue slides cut at 4 to 5 microns and dried overnight at 56°C.
Minimum Volume
Not provided
Container
Paraffin block transport pouch or slide mailer
Collection Instructions
Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 72 hours according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18 and 24 hours.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Fixative other than neutral buffered formalin; quantity not sufficient for analysis; tumor other than breast tumor