HER-2/CEP17 FISH, Breast With Reflex to Immunohistochemistry (IHC) if Group 2, 3, 4 by FISH
Use
Tissues are evaluated for gene amplification status by FISH. Specimens demonstrating a classification of Group 2, 3, 4 by FISH are evaluated by immunohistochemistry.
Special Instructions
Not provided.
Limitations
The use of fixatives other than 10% neutral-buffered formalin or variances in fixation time below six hours or exceeding 72 hours can result in unreliable outcomes. Additionally, decalcification procedures may adversely impact antigenicity and DNA quality, potentially affecting the test results.
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
LOINC Codes
- 31150-6 - ERBB2 gene Dp Tiss Ql FISH
- 49683-6 - ERBB2 copy num/Chr 17 copy num Tiss FISH
- 74860-8 - ERBB2 copy num/nucleus EntNum Tiss FISH
- 74861-6 - Chr 17 copy num/nucleus EntNum Tiss FISH
- 62361-1 - Cells counted
- 19147-8 - Ref Lab Test Ref Range
- 59465-5 - Path Rev
- 18474-7 - Her2 Ag Tiss Ql ImStn
- 77202-0 - Laboratory comment Report
- 69426-5 - Medical director review
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 seven unstained tissue slides
Minimum Volume
Not provided
Container
Paraffin block transport pouch or slide mailer
Collection Instructions
Specimen should be fixed in 10% neutral-buffered formalin. Time from tissue acquisition to fixation should be as short as possible. Fixation time should be between six and 72 hours according to ASCO/CAP guidelines.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Tumor other than breast tumor
Other tests from different labs that may be relevant