ARUP's Laboratory Test Directory

ERBB2 (HercepTest®) Tissue Assay, Paraffin : 0049174

Mnemonic: HERCEPIP

Methodology: Immunohistochemistry
Performed: Mon-Fri
Reported: 1-5 days
Specimen Required: Collect: Tumor Tissue

Specimen Preparation: Formalin fix and paraffin embed specimen. If sending precut slides, do not oven bake. Protect paraffin block and/or slides from excessive heat.

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. IMMUNOHISTOCHEMISTRY ORDERING AND SUBMISSION DETAILS: Submit electronic request. If you do not have electronic ordering capability, use an ARUP Immunohistochemsitry form (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 fixed in formalin substitute.

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% of cells.
2+ Equivocal Complete membrane staining that is nonuniform or weak but with obvious circumferential distribution in at least 10% of cells, or intense complete membrane staining in 30% or less of tumor cells.
3+ Positive Uniform intense membrane staining of more than 30% 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+ resul

 
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

Interpretive Data: Refer to report.
CPT Code(s): 88360
Cross References: HER2 (ERBB2 (HercepTest®) Tissue Assay, Paraffin) , HER2 IHC (ERBB2 (HercepTest®) Tissue Assay, Paraffin) , Herceptin (ERBB2 (HercepTest®) Tissue Assay, Paraffin)
 
 

 

 

 
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