Estrogen Receptor, technical only
Companion Diagnostic
Estrogen Receptor, technical only is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
Estrogen receptors (ER), encoded by the ESR1 and ESR2 genes, exist as alpha and beta isoforms. ER alpha can primarily be found in luminal epithelial cells, where it promotes normal development and cell proliferation. In cancerous cells, increased ER activity from overexpression leads to hyperproliferation and tumor formation. ER is a crucial marker for predicting responses to endocrine therapy. High ER levels in tumors correlate with better responses to such treatments. Technical component only.
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. Stated turn-around-times 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
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)
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 |