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HER-2 Immunohistochemistry (IHC), Gastric With Reflex to FISH if 2+ by IHC
CPT:
88360. If reflex testing is performed, concomitant CPT codes/charges will apply.
Synonyms
- HER-2/neu Oncoprotein, Paraffin Block
Special Instructions
Direct any questions regarding this test to oncology customer service at 800-345-4363.
Expected Turnaround Time
4 - 5 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 seven 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 6 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
Evaluation of tumor tissue. Specimens demonstrating 2+ (moderate) staining for the HER-2/neu protein are evaluated for gene amplification status by FISH. In such cases, FISH provides a better indication of potential response to therapy.
Limitations
Use of fixatives other than 10% formalin may not yield equivalent or satisfactory 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, randomized controlled trial. Lancet. 2010 Oct 16; 376(9742):687-697. Erratum: 2010 Oct 16;376(9749):1302.20728210
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
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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, randomized controlled trial. Lancet. 2010 Oct 16; 376(9742):687-697. 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 |
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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, randomized controlled trial. Lancet. 2010 Oct 16; 376(9742):687-697. Erratum: 2010 Oct 16;376(9749):1302.20728210 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 |
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