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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.
Updated on 04/4/2021

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


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
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
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
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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