HER2, FISH – ScanLab Center

Sub Category

Oncology (Solid Tymors)

Synonym/Aliases

Human Epidermal Growth Factor Receptor 2 (Her2) Fish. Her2/neu, Fish; C-erbb2, Fish; Erbb2, Fish; Hercept Test, Fish.

Abbreviations

HER2

^Type

Individual Test

^Results

RESULTS READY WITHIN 7 DAYS

^Method

FLUORESCENT IN SITU HYBRIDIZATION (FISH)

^Temp

ROOM TEMPRATURE

^Setup

BATCHED

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. CLINICAL HISTORY, HISTOLOGY (H&E) REPORT ARE MANDATORY.

Patient preparation

- N/A

Sample type

TUMOR POSITIVE FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BLOCK.

Container/ preservative

FORMALIN FIXED, PARAFFIN EMBEDDED BLOCKS [PREFERRED]. ALTERNATIVELY, 4-5 MICRONS UNSTAINED SECTIONS ON POSITIVELY-CHARGED SLIDES (≥FOUR SLIDES).

Sample volume

SUFFICIENT RESIDUAL TISSUE/ TUMOR MUST BE AVAILABLE ON THE BLOCK

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE (E.G. HEPARIN); INSUFFICIENT SAMPLE.

Other Instructions

- N/A

Reference intervals

INTERPRETIVE DATA IS PROVIDED ON THE REPORT.

Clinical Utility

THERANOSTIC MARKER FOR BREAST CANCER I.E. PREDICTS RESPONSE TO HER2 TARGETED THERAPY E.G. TRASTUZUMAB (HERCEPTIN), PERTUZUMAB, LAPATINIB. HER2 TESTING USING FLUORESCENT IN SITU HYBRIDIZATION (FISH) IS INDICATED FOR SAMPLES WITH EQUIVOCAL (2+) HER2 RESULTS ON IHC.

Test Limitations/ Confounders

FOR OPTIMAL RESULTS, THE WET TISSUE (PRIMARY SPECIMEN) SHOULD BE FIXED IN 10% NEUTRAL BUFFERED 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).