HER-2/neu Immunohistochemistry (IHC), Gastric Paraffin

CPT: 88360
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Test Details


  • c-erbB-2


HER-2-positive carcinomas predict response to humanized monoclonal antibody trastuzumab (Herceptin®) in conjunction with chemotherapy in patients with advanced or metastatic gastric or gastro-esphageal junction carcinoma.


Use of fixatives other than 10% formalin, fixation times less than six hours or greater than 48 hours may not yield reliable results.


Immunohistochemistry (IHC)

Specimen Requirements


Tumor (formalin-fixed, paraffin-embedded)


One paraffin block or five unstained, positively charged tissue slides cut at 4 to 5 microns and dried for one hour at 60°C.


Paraffin block transport pouch or slide mailer


FFPE tissue, preserved in 10% neutral buffered formalin, fixed for 18 to 24 hours. ASCO/CAP 2013 guidelines recommend fixation time between six and 72 hours for breast tissue; however, special ASCO/CAP guidelines have not been established for gastric cancer samples.

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

Tumor other than gastric tumor

Clinical Information

Special Instructions

Please direct any questions regarding this test to oncology customer service at 800-345-4363. Please note: fixation time and fixative used must be indicated on the test request form.


Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28; 376(9742):687-697. 20728210
Hofmann M, Stoss O, Shi D, et al. Assessment of a HER2 scoring system for gastric cancer: Results from a validation study. Histopathology. 2008 Jun; 52(7):797-805. 18422971


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
480226 HER-2/neu IHC,Gastric,Paraffin 480423 HER-2/neu (C-erbB-2) 18474-7
480226 HER-2/neu IHC,Gastric,Paraffin 480424 Scoring Guide N/A
480226 HER-2/neu IHC,Gastric,Paraffin 480374 Comment 77202-0
480226 HER-2/neu IHC,Gastric,Paraffin 483318 Fixation Time N/A
480226 HER-2/neu IHC,Gastric,Paraffin 483319 Fixative N/A
480226 HER-2/neu IHC,Gastric,Paraffin 480232 Director Review 69426-5

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