PD-L1 (SP263), technical only
Companion Diagnostic
PD-L1 (SP263), technical only is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
PD-L1 binds to PD-1 receptors found on the T-cell and B-cell surfaces to inhibit proliferation and cytokine production. The PD-L1 (SP263) IHC assay is an FDA approved assay indicated as a companion diagnostic in NSCLC with TECENTRIQ® (atezolizumab) and LIBTAYO® (cemiplimab-rwlc). Technical component only. Pathologist read not included.
Special Instructions
Fresh Tissues: Specimens may be fixed in formalin for 24-72 hours by collection sites, then transferred to 70% ethanol and stored at 2-8°C for longer term storage if needed. Samples must be tested 3 months after placing in ethanol. Unstained 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
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 |