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

CPT

88360

Synonyms
  • c-erbB-2
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  • Updated on 05/02/2025

Test Details

Methodology

Immunohistochemistry (IHC)

Result Turnaround Time

2 - 4 days

5 - 9 days

2 - 4 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

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.

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.

Limitations

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

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 Instructions

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

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
Bartley A, Washington M, Colasacco C, et al. HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. J Clin Oncol. 2017 Feb;35(4):446-464.28129524
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
Order Code480226
Order Code NameHER-2/neu IHC,Gastric,Paraffin
Order Loinc
Result Code480423
Result Code NameHER-2/neu (C-erbB-2)
UofM
Result LOINC18474-7
Order Code480226
Order Code NameHER-2/neu IHC,Gastric,Paraffin
Order Loinc
Result Code480424
Result Code NameScoring Guide
UofM
Result LOINCN/A
Order Code480226
Order Code NameHER-2/neu IHC,Gastric,Paraffin
Order Loinc
Result Code480374
Result Code NameComment
UofM
Result LOINC77202-0
Order Code480226
Order Code NameHER-2/neu IHC,Gastric,Paraffin
Order Loinc
Result Code483318
Result Code NameFixation Time
UofM
Result LOINCN/A
Order Code480226
Order Code NameHER-2/neu IHC,Gastric,Paraffin
Order Loinc
Result Code483319
Result Code NameFixative
UofM
Result LOINCN/A
Order Code480226
Order Code NameHER-2/neu IHC,Gastric,Paraffin
Order Loinc
Result Code480232
Result Code NameDirector Review
UofM
Result LOINC69426-5