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.
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Test Details

Synonyms

  • HER-2/neu Oncoprotein, Paraffin Block

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)

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

Clinical Information

Special Instructions

Direct any questions regarding this test to oncology customer service at 800-345-4363.

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
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
483360 HER-2 IHC RFX FISH, GASTRIC 483362 HER-2/neu (C-erbB-2) 18474-7
483360 HER-2 IHC RFX FISH, GASTRIC 480424 Scoring Guide N/A
483360 HER-2 IHC RFX FISH, GASTRIC 480382 Comment 77202-0
483360 HER-2 IHC RFX FISH, GASTRIC 480383 Fixation Time N/A
483360 HER-2 IHC RFX FISH, GASTRIC 480387 Fixative N/A
483360 HER-2 IHC RFX FISH, GASTRIC 480241 Director Review 72486-4
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483344 HER-2/CEP17 FISH, Gastric 483345 HER-2/neu FISH, Gastric 31150-6
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483344 HER-2/CEP17 FISH, Gastric 483299 HER-2/CEP17 Ratio 49683-6
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483344 HER-2/CEP17 FISH, Gastric 483349 Avg Num Her-2 signals/nucleus: 74860-8
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483344 HER-2/CEP17 FISH, Gastric 483359 Avg Num CEP17 probes/nucleus: 74861-6
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483344 HER-2/CEP17 FISH, Gastric 483361 Methodology: 49549-9
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483344 HER-2/CEP17 FISH, Gastric 483005 Director Review N/A

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