HER2 by IHC, Pan-Tumor

CPT: Contact CPT coding at 800-222-7566, ext. 6-8400.

Synonyms

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

Special Instructions

Please direct any questions regarding this test to oncology customer service at 800-345-4363. Please note: Fixation time and fixative used must be indicated on the test request form.


Expected Turnaround Time

4 days


Specimen Requirements


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 60ºC


Minimum Volume

Three unstained slides


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

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


Test Details


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.


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.


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):47-58.37870536

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