Alternative Name
HER2 Breast ISH
Methodology
In Situ Hybridization (ISH)
Test Description
The FDA approved Ventana Medical Systems’ (Ventana) INFORM HER2 Dual ISH DNA Probe set is intended to determine HER2 gene status by enumeration of the ratio of theHER2 gene to Chromosome 17 in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. The INFORM HER2 Dual ISH DNA Probe set is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.
Specimen Requirements
  • A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type

    or

  • One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered

  • Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.

Storage and Transportation
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
CPT Code(s)*
88377x1
Turnaround Time
Global: 72 hours, Tech-Only (stain only): 72 hours
Level of Service
Global
Stain Only

*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.