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ERBB2 (HER2/neu) (HercepTest) by Immunohistochemistry, Tissue with Reflex to FISH if 2+
Ordering Recommendation
Aid in prediction of response to HER2-directed therapy in patients with breast carcinoma or gastroesophageal adenocarcinoma. Refer to ARUP Immunohistochemistry Stain Offerings brochure at www.aruplab.com/ap/resources.
New York DOH Approval Status
Specimen Required
Tumor tissue
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue within 30 minutes of removal from patient. Fixative duration: 6-72 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.
Room temperature or refrigerated. Ship in cooled container during summer months.
Paraffin block with no tumor tissue remaining. Specimens with fixation delayed for more than one hour. Specimens fixed in any other fixative other than 10 percent neutral buffered formalin. Tissue fixed for less than 6 hours or greater than 72 hours. Decalcified specimens.
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.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Methodology
Immunohistochemistry
Performed
Mon-Fri
Reported
1-5 days
If reflexed, add 3-7 days.
Reference Interval
Interpretive Data
Refer to report.
FDA
Note
If ERBB2 (HercepTest) result is 2+, then ERBB2 (HER2/neu) Gene Amplification by FISH, Tissue will be added. Additional charges apply.
Hotline History
CPT Codes
88360; if reflexed, add 88377
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 0049171 | Homogenous Pattern | |
| 0049184 | Intensity of Staining | |
| 0049188 | Percent of Cells/Circumferential | |
| 0049244 | Fixative Used | |
| 0049246 | Time from Bx to Fixative | |
| 0049247 | Duration of Fixation | |
| 0049520 | ERBB2(HercepTest)Rflx to FISH if 2+ | 18474-7 |
| 3005643 | Sample Adequacy | |
| 3005644 | HER2 Reference Number | 94736-6 |
| 3005645 | HER2 Tissue Source | 31208-2 |
Aliases
- 2+ FISH reflex
- c-erbB2 Hercept IHC
- ERBB2 Hercept IHC
- HER-2/neu Hercept IHC
- HER2 (ERBB2 (HercepTest(R)) Tissue Assay, Paraffin) with Reflex to FISH if 2+
- HER2 IHC (ERBB2 (HercepTest(R)) Tissue Assay, Paraffin) with Reflex to FISH if 2+
- Herceptin (ERBB2 (HercepTest(R)) Tissue Assay, Paraffin) with Reflex to FISH if 2+
