Find Locations
For hours, walk-ins and appointments.Synonyms
- c-erbB-2
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.
Expected Turnaround Time
5 - 9 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.
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
Test Details
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)
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 |
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