ARUP's Laboratory Test Directory

ERBB2 (HER2/neu) (HercepTest) by Immunohistochemistry, Tissue with Reflex to FISH if 2+ : 0049178

Mnemonic: HERCEP2IP

Methodology: Immunohistochemistry
Performed: Mon-Fri
Reported: 1-5 days
Reflexed to HER2FISH (0049218) if 2+, FISH assay will be performed and reported within 4-12 days, if no repeats are required.
Specimen Required: Collect: Tumor tissue

Specimen Preparation: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue within 30 minutes of removal from patient. Fixative duration: 8-48 hours. Transport tissue block or 10 unstained (3-to 5-micron thick sections), positively charged slides in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800)522-2787. (Min: 6 slides) If sending precut slides, do not oven bake.

Storage/Transport Temperature: Room temperature or refrigerated. Ship in cooled container during summer months.

Remarks: Pathology report including tissue source and tumor origin must be submitted. Document time from tissue acquisition to fixation and fixation duration on requisition or enter at time of order. IMMUNOHISTOCHEMISTRY ORDERING AND SUBMISSION DETAILS: Submit electronic request. If you do not have electronic ordering capability, use an ARUP Immunohistochemistry form (#32978) with an ARUP client number. For additional technical details, please contact ARUP Client Services at (800) 522-2787.

Unacceptable Conditions: Paraffin block with no tumor tissue remaining. Specimens with fixation delayed for more than 30 minutes. Specimens fixed in any other fixative other than 10 percent neutral buffered formalin. Tissue fixed for less than 8 hours or greater than 48 hours. Cytology specimens fixed in alcohol.

Stability (collection to initiation of testing): Ambient: Indefinite; Refrigerated: Indefinite ; Frozen: Unacceptable
Reference Interval:
Effective August 15, 2011
 
Breast Tumors
These results are given as 0 to 3+ with the following definitions and interpretations.
Grade Interpretation Microscopic Finding
0 Negative No staining is observed in invasive tumor cells.
1+ Negative Weak, incomplete membrane staining in any proportion of invasive tumor cells, or weak, complete membrane staining in less than 10 percent of cells.
2+ Equivocal Complete membrane staining that is nonuniform or weak but with obvious circumferential distribution in at least 10 percent of cells, or intense complete membrane staining in 30 percent or less of tumor cells.
3+ Positive Uniform intense membrane staining of more than 30 percent of invasive tumor cells.
3+ reactions with HercepTest are considered a positive result and indicative of a possible response to Herceptin® therapy. 0 and 1+ reactions are considered negative and suggest a lack of response to Herceptin therapy. It is recommended that a 2+ result be confirmed by FISH testing, and FISH results should be considered definitive.

 
Gastric Specimens
These results are given as 0 to 3+ with the following definitions and interpretations.
Grade Interpretation Surgical Specimen-Microscopic Finding Biopsy Specimen-Microscopic Finding
0 Negative No reactivity or membranous reactivity in less than 10 percent of cells is observed. No reactivity or no membranous reactivity in any or less than 5 clustered tumor cells.
1+ Negative Faint or barely perceptible membranous reactivity in at least 10 percent of cells; cells are reactive in part of their membrane. Tumor cell cluster, at least 5 cells, with a faint or barely perceptible membranous reactivity irrespective of percentage of tumor cells stained.
2+ Equivocal Weak to moderate complete, basolateral or lateral membranous reactivity in at least 10 percent of tumor cells. Tumor cell cluster, at least 5 cells, with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumor cells stained.
3+ Positive Moderate to strong complete, basolateral or lateral membranous reactivity in at least 10 percent of tumor cells. Tumor cell cluster with a strong complete basolateral or lateral membranous reactivity irrespective of percentage of tumor cells stained.
3+ reactions with HercepTest are considered a positive result and indicative of a possible response to Herceptin® therapy. 0 and 1+ reactions are considered negative and suggest a lack of response to Herceptin therapy. It is recommended that a 2+ result be confirmed by FISH testing, and FISH results should be considered definitive.

Interpretive Data: Refer to report.
Note: If ERBB2 (HercepTest) result is 2+, then ERBB2 (HER2/neu) Gene Amplification by FISH will be added. Additional charges apply.
 
CPT Code(s): 88360, if reflexed, add 88368 x2
Cross References: HER2 (ERBB2 (HercepTest®) Tissue Assay, Paraffin) with Reflex to FISH if 2+ , HER2 IHC (ERBB2 (HercepTest®) Tissue Assay, Paraffin) , Herceptin (ERBB2 (HercepTest®) Tissue Assay, Paraffin)