HER-2, IHC with Reflex to FISH

Test Code

15547

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 tissue

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 charges/+ 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: Indefinite
Refrigerated: Indefinite
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Non-invasive tumors • Received frozen

Methodology
Immunocytochemical Assay • Reflex: Fluorescence in situ Hybridization (FISH)

Setup Schedule

A.M. Sets up 7 days a week.

Report Available

Reports in 9 to 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.

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.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.