HER-2 Immunohistochemistry (IHC) With Reflex to FISH if 2+ by IHC With Reflex to HERmark® if FISH Equivocal

CPT: 88360. If reflex testing is performed, concomitant CPT codes/charges will apply.
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Test Details

Synonyms

  • c-erb-2

Use

Tissues are evaluated by immunohistochemistry. 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 7 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

Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between six and 72 hours according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18 and 24 hours.

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

Tumor other than breast tumor

Clinical Information

Special Instructions

Fixation time and fixative used must be indicated on the test request form.

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

References

Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1; 31(31):3997-4013. 24101045

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
483200 HER2 Rx FISH Rx HERmark(R) 480528 HER-2/neu (C-erbB-2) 18474-7
483200 HER2 Rx FISH Rx HERmark(R) 480458 Scoring Guide 19147-8
483200 HER2 Rx FISH Rx HERmark(R) 483202 Comment 77202-0
483200 HER2 Rx FISH Rx HERmark(R) 483203 Fixation Time N/A
483200 HER2 Rx FISH Rx HERmark(R) 483204 Fixative N/A
483200 HER2 Rx FISH Rx HERmark(R) 483205 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 483210 HER-2/neu Gene Amplification 483211 HER-2/neu Gene Amplification 31150-6
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483210 HER-2/neu Gene Amplification 483212 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 483210 HER-2/neu Gene Amplification 483328 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 483210 HER-2/neu Gene Amplification 483329 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 483210 HER-2/neu Gene Amplification 483327 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 483210 HER-2/neu Gene Amplification 483213 Reflex to HERmark N/A
Reflex 2 000000 482011 000000 11526-1
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483210 HER-2/neu Gene Amplification 483213 Reflex to HERmark N/A
Reflex 2 000000 482010 000000 72383-3
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483210 HER-2/neu Gene Amplification 483213 Reflex to HERmark N/A
Reflex 2 000000 482013 000000 72382-5
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483210 HER-2/neu Gene Amplification 483213 Reflex to HERmark N/A
Reflex 2 000000 482017 000000 19147-8
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483210 HER-2/neu Gene Amplification 483213 Reflex to HERmark N/A
Reflex 2 000000 482015 000000 77202-0
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483210 HER-2/neu Gene Amplification 483213 Reflex to HERmark N/A
Reflex 2 000000 482016 000000 49549-9
Reflex Table for HER-2/neu (C-erbB-2)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483210 HER-2/neu Gene Amplification 483218 Director Review 72686-4

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