Her2/neu Gastric cancer, technical only
Companion Diagnostic
Her2/neu Gastric cancer, 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 in which overexpression bodes poor prognosis in untreated gastric and gastroesophageal junction (GEJ) adenocarcinomas. The Her2/neu Pathway IHC assay identifies tumors with HER2 overexpression that might respond to HER2 targeted therapy with trastuzumab. 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
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.
FDA ApprovedCompanion Diagnostic
Methodology
Immunoassay (IHC)
Biomarkers
HER2/neu
Protein
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
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).
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 |