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HER-2, IHC with Reflex to HER-2, FISH
Test Code15547
CPT Codes
88360
Includes
If HER-2, IHC results are 2+, then HER-2, FISH testing for confirmation will be performed at an additional charge (CPT code(s): 88377).
Preferred Specimen
Formalin-fixed, paraffin-embedded tumor tissue block submitted in an IHC specimen transport kit
Other Acceptable Specimens
5 unstained (4-microns) sections, positively charged on Poly-L-Lysine or Silane-coated slides
Instructions
Tumor paraffin block (formalin-fixed only) or five 4-micron unstained sections on Poly-L-Lysine or Silane coated slides. Do not place paper labels with adhesive backing on slides. Use pencil or xylene resistant pen to write on the frosted end of the slide only.
Invasive or metastatic breast cancer formalin fixed paraffin embedded tissue or charged/+slides from formalin fixed paraffin embedded tissue.
Specimen must be fixed in 10% neutral buffered formalin. Fixation between 6 and 72 hours is recommended. Pathology report must accompany paraffin block or slides.
Information required in this report include: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis, and IHC score, if performed elsewhere.
Ship at room temperature. Do not freeze.
Invasive or metastatic breast cancer formalin fixed paraffin embedded tissue or charged/+slides from formalin fixed paraffin embedded tissue.
Specimen must be fixed in 10% neutral buffered formalin. Fixation between 6 and 72 hours is recommended. Pathology report must accompany paraffin block or slides.
Information required in this report include: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis, and IHC score, if performed elsewhere.
Ship at room temperature. Do not freeze.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Refrigerated: Indefinitely
Frozen: Unacceptable
Methodology
Immunocytochemical Assay • Reflex: Fluorescence in situ Hybridization (FISH)
Setup Schedule
Set up: Mon-Fri; Report available: 2 days
(If initial testing reflexes to HER-2/NEU, FISH, report is available 7-10 days)
(If initial testing reflexes to HER-2/NEU, FISH, report is available 7-10 days)
Limitations
Lack of HER-2 protein overexpression or gene amplification suggests the patient will not respond to trastuzumab therapy; however, clinical trials are needed to confirm this presumption. Similarly, trastuzumab response, or lack thereof, in patients with confirmed equivocal HER-2 test results is uncertain. Trastuzumab is clinically indicated only for patients in whom HER-2 protein overexpression or gene amplification can be confirmed.
Reference Range
See Laboratory Report
Clinical Significance
HER-2/NEU expression is commonly performed on breast carcinomas. Women who have tumors that overexpress HER-2/NEU are most likely to be responsive to monoclonal antibody therapy directed against this target.
Performing Laboratory
Quest Diagnostics Nichols Institute |
14225 Newbrook Drive |
Chantilly, VA 20153 |