ER/PR/HER2 with Reflex to HER2 FISH, Paraffin Block

Test Code
10970


CPT Codes
88360 (x3)

Includes
If result is 2+, then HER2 FISH is performed at an additional charge (CPT code(s): 88377). Includes Pathologist review for presence of malignant cells.


Preferred Specimen
Formalin-fixed paraffin-embedded tissue in IHC specimen transport kit


Other Acceptable Specimens
Nine 4-micron unstained sections


Instructions
Tumor paraffin block (formalin-fixed only) or nine 4-micron unstained sections on Poly-L-Lysine or Silane coated slides.
See Specimen Collection Section, Oncology.
Please submit stained H & E slide and a copy of the pathology report. Ship at room temperature. Invasive or metastatic breast cancer formalin fixed paraffin-embedded 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
Tissue
Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Not Established

Micron unstained sections
Room temperature: Indefinite
Refrigerated: Unacceptable
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Non-invasive tumors


Methodology
Immunohistochemical Assay (IHC) • Fluorescence in situ Hybridization (FISH)

Setup Schedule
REPORTS IN 7-10 DAYS


Report Available
Reports in 7 to 10 days.


Clinical Significance
Estrogen and progesterone receptor assays are routinely performed on breast carcinomas to assess responsiveness to endocrine therapy and prognosis. HER-2 is associated with cellular proliferation activity. Over-expression is observed in 20-25% of women with breast cancer. These patients are potential candidates for monoclonal therapy.





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.