Her2/neu Gastric cancer
Companion Diagnostic
Her2/neu Gastric cancer 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 with overexpression indicating 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.
Special Instructions
Fresh tissue biopsies and resections should be immersed in fixative within one hour. The time of tissue immersion in fixative must be recorded and submitted to the laboratory. FFPE block or fresh tissue is preferred. For unstained slides, positively charged glass slides are required to prevent background staining and tissue loss. Slides should remain unbaked.
Limitations
Specimens must be fixed in 10% NBF or B plus, and all other fixatives will be rejected. Fresh tissues should be fixed for 6-72 hours (preferably 48-72 hours). Unstained slides and FFPE blocks have indefinite stability if fixed appropriately. Specimens may be transferred to 70% alcohol for transportation after fixation.
FDA ApprovedCompanion Diagnostic
Methodology
Immunoassay (IHC)
Biomarkers
HER2
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
Fresh Tissues should be fixed in a 20:1 fixative to tissue ratio in 10% neutral buffered formalin for 6-72 hours, ideally 48-72 hours.
Storage Instructions
15°C to 25°C
Causes for Rejection
Specimens not fixed in 10% NBF or B plus.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | ≤ 72 Hours |