Alternative Name
HER2 neu
Methodology
FISH
Test Description

Probes: TP53 (17p13.1) | SMS Critical Region (SMSCR) (17p11.2) | Centromere 17 | RARA (17q21.1
Disease(s): Breast cancer
Testing is performed only on a global basis at this time.

Clinical Significance

Testing is performed only on a global basis at this time. This panel supplements an equivocal HER2 FISH result by analyzing flanking markers RARA, Smith-Magenis Syndrome Critical Region (SMSCR), and TP53. The additional markers can differentiate gains consistent with polysomy, co-amplification of HER2 and the centromere, or amplification of just the centromere region, which can mask HER2 amplification. Testing can help identify which equivocal patients have appropriate gene status for anti-HER2 therapy. The Equivocal Panel is available as reflex after HER2 FISH global test orders, as an add-on to HER2 FISH, or it can be ordered when HER2 FISH is performed elsewhere. In the latter case when HER2 is tested elsewhere, NeoGenomics will run HER2 concurrently with the Equivocal Panel unless HER2 was tested previously in our lab on the same block. This is because HER2 is a useful internal reference for the Equivocal Panel.

Specimen Requirements
  • Pathology Report: A copy of the pathology report is required (global cases only).
  • Bone marrow aspirate: N/A
  • Peripheral blood: N/A
  • Fresh, unfixed tissue: N/A
  • Fluids: N/A
  • Paraffin block: Send paraffin block.
  • Cut slides: H&E slide (required) plus 4 unstained slides cut at 4-5 microns for stand-alone orders. If ordering globally with reflex after HER2 Breast FISH, add one cut unstained slide (5 total).
Storage and Transportation

Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

CPT Code(s)*
88374x1, 88367x1 automated or 88377x1, 88368x1 manual. Add 88374x1 or 88377x1 if HER2 is also performed.
Turnaround Time

3-5 days. Add 3-5 days if HER2 FISH is performed first.

Level of Service
Global

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.