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HER2 by IHC, Pan-Tumor

CPT 88360
Synonyms

C-ERBB2; HER2 IHC; HER2 Overexpression; HER2 Pan-Cancer; HER2/neu

Test Details

Turnaround Time

4 days

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Use

HER2 is known to be expressed in various solid tumor types. This test is used to determine eligibility for HER2-targeted therapy in patients with any solid tumor. There is no equivalent FISH assay or FISH reflex scenario for this pan-tumor indication. For tumor types with specific test devices (e.g., breast, gastric, CRC), use of those tests is recommended instead.

Special Instructions

Please direct any questions regarding this test to Oncology Customer Service at 800-345-4363.

Limitations

Use of fixatives other than 10% neutral-buffered formalin or fixation times less than six hours or more than 48 hours may not yield reliable results.

Methodology

Immunohistochemistry (IHC)

References

Meric-Bernstam F, Makker V, Oaknin A, et al. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-Pan Tumor02 Phase II  Trial. J Clin Oncol. 2024 Jan 1;42(1):47-58. PubMed 37870536

Specimen Requirements

Information on collection, storage, and volume

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tumor

Volume

One paraffin block or five unstained, positively-charged tissue slides cut at 4-5 microns and dried for one hour at  60°C

Minimum Volume

Three unstained slides

Container

Paraffin block transport pouch or slide mailer

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

 Absence of tumor; unacceptable specimen types; non-indicated tumor types

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.

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