HER2 by IHC, Pan-Tumor

TEST: 484482
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CPT: Contact CPT coding at 800-222-7566, ext. 6-8400.
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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

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.

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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