HER2 neu
Use
HER2 is a membrane receptor tyrosine kinase expressed in breast cells. HER2 amplification is observed in malignant transformation and tumor progression in a fraction of patients with breast cancer. The Pathway Her-2/neu IHC assay is a companion diagnostic used to identify patients who are eligible for treatment with HERCEPTIN, KADCYLA, or ENHERTU.
Special Instructions
Fresh Tissue Biopsies and resections: Specimens should be immersed in fixative within one hour of the biopsy or resection. The time of immersion of the tissue in fixative should be recorded and submitted to the laboratory.
Limitations
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (Fixed (Non-FFPE))
Volume
Not provided
Minimum Volume
Not provided
Container
10% neutral buffered formalin (NBF) for 6-72 hours (48-72 hours PREFERRED)
Collection Instructions
Fixative should be at a 20:1 fixative to tissue ratio.
Storage Instructions
15°C to 25°C
Causes for Rejection
Specimens must be fixed in 10% NBF or B plus. All other fixatives will be rejected.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | ≤ 72 Hours for Fresh Tissue |