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

CPT: 88360
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Test Details

Synonyms

  • c-erbB-2

Use

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.

Limitations

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

Methodology

Immunohistochemistry (IHC)

Specimen Requirements

Specimen

Tumor (formalin-fixed, paraffin-embedded)

Volume

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

Container

Paraffin block transport pouch or slide mailer

Collection

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.

References

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

LOINC® Map

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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The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf