Category
Anatomic Pathology
Sub Category
Surgical/ Histopathology
Synonyms/Aliases
Breast Biomarker Testing; ER, PR, HER2/NEU; ER, PR, ERBB2. HER2 Is Also Known As C-ERBB2, ERBB2, HERCEPT Test.
Abbreviations
ER, PR, HER2
Type
Profile/ panel (bundled tests)
7-14 Days
Results Ready in 7-14 Days
Method
Immunostain (± Reporting)
Temp
Room temperature; refrigerated is also acceptable.
Setup
Mon-Fri
Components Parameters
3 Ihc Markers I.e. Estrogen Receptor (ER), Progesterone Receptor (PR) & Human Epidermal Growth Factor Receptor 2 (HER2).
Pre-analytic Considerations
N/A
Test Ordering Instructions
Fill out test request form fully & legibly. Provide your contact information & complete history. H&E report required.
Patient preparation
N/A
Sample type
Formalin Fixed, Paraffin Embedded Blocks.
Container/ preservative
Formalin Fixed, Paraffin Embedded Blocks.
Sample volume
Residual tissue must be available on the block.
Rejection criteria
Labeling Issue (Unlabeled/ Mislabeled); Missing Request Form; Mismatch Between Request Form & Sample Details; Wrong Sample Type Or Fixative; Insufficient/ Depleted Sample.
Other Instructions
Each of the markers can also be ordered individually.
Reference intervals
Not Applicable
Clinical Utility
Prognostic / Theranostic
Test Limitations/ Confounders
HER2 testing using Fluorescent in SITU Hybridization (fish) is indicated for equivocal (2+) HER2 results on IHC. For optimal results, the wet tissue (primary specimen) should be fixed in Formalin within 30 minutes of removal from the patient and the duration of fixation should be within 6-72 hours (I.e. Not less than 6 hours and not more than 72 hours) to avoid false negative results.