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HER-2 Immunohistochemistry (IHC), Gastric With Reflex to FISH if 2+ by IHC

Test Number 483360
Test number copied
CPT 88360. If reflex testing is performed, concomitant CPT codes/charges will apply.
Synonyms
  • HER-2/neu Oncoprotein, Paraffin Block

Test Details

Methodology

Immunohistochemistry (IHC)

Result 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.

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.

Special Instructions

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

Limitations

Use of fixatives other than 10% formalin may not yield equivalent or satisfactory results.

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 Instructions

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

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

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
Order Code483360
Order Code NameHER-2 IHC RFX FISH, GASTRIC
Order Loinc
Result Code483362
Result Code NameHER-2/neu (C-erbB-2)
UofM
Result LOINC18474-7
Order Code483360
Order Code NameHER-2 IHC RFX FISH, GASTRIC
Order Loinc
Result Code480424
Result Code NameScoring Guide
UofM
Result LOINCN/A
Order Code483360
Order Code NameHER-2 IHC RFX FISH, GASTRIC
Order Loinc
Result Code480382
Result Code NameComment
UofM
Result LOINC77202-0
Order Code483360
Order Code NameHER-2 IHC RFX FISH, GASTRIC
Order Loinc
Result Code480383
Result Code NameFixation Time
UofM
Result LOINCN/A
Order Code483360
Order Code NameHER-2 IHC RFX FISH, GASTRIC
Order Loinc
Result Code480387
Result Code NameFixative
UofM
Result LOINCN/A
Order Code483360
Order Code NameHER-2 IHC RFX FISH, GASTRIC
Order Loinc
Result Code480241
Result Code NameDirector Review
UofM
Result LOINC72486-4
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 1
Order Code483344
Order NameHER-2/CEP17 FISH, Gastric
Result Code483345
Result NameHER-2/neu FISH, Gastric
UofM
Result LOINC31150-6
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 1
Order Code483344
Order NameHER-2/CEP17 FISH, Gastric
Result Code483299
Result NameHER-2/CEP17 Ratio
UofM
Result LOINC49683-6
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 1
Order Code483344
Order NameHER-2/CEP17 FISH, Gastric
Result Code483349
Result NameAvg Num Her-2 signals/nucleus:
UofM
Result LOINC74860-8
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 1
Order Code483344
Order NameHER-2/CEP17 FISH, Gastric
Result Code483359
Result NameAvg Num CEP17 probes/nucleus:
UofM
Result LOINC74861-6
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 1
Order Code483344
Order NameHER-2/CEP17 FISH, Gastric
Result Code483361
Result NameMethodology:
UofM
Result LOINC49549-9
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
Reflex 1
Order Code483344
Order NameHER-2/CEP17 FISH, Gastric
Result Code483005
Result NameDirector Review
UofM
Result LOINCN/A