HER2 neu, technical only
Companion Diagnostic
HER2 neu, technical only is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
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. Technical component only. Pathologist read not included.
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. Paraffin Embedded Tissue FFPE Block: Total fixation time must be noted. FFPE block or fresh tissue preferred. Unstained Paraffin Embedded Tissue Slides: Positively charged glass slides required to prevent background staining and prevent tissue loss. Slides should be left unbaked.
Limitations
Specimens must be fixed in 10% NBF or B plus. All other fixatives will be rejected. This test does not include a pathologist read. It is crucial to ensure correct specimen handling to prevent artifacts that could affect the test results. The test is focused solely on the technical component and does not provide comprehensive pathology evaluation.
FDA ApprovedCompanion Diagnostic
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (Fresh)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Fixative should be at a 20:1 fixative to tissue ratio, 10% neutral buffered formalin (NBF) for 6-72 hours (48-72 hours PREFERRED). Immersion of the tissue in fixative must be within one hour of the biopsy or resection.
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 |