PD-L1 (22C3)
Companion Diagnostic
PD-L1 (22C3) 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 T-cells and B-cells to inhibit proliferation and cytokine production. The PD-L1 (22C3) PharmDx IHC assay is approved as a companion diagnostic for several cancers, including NSCLC, ESCC, cervical cancer, HNSCC, TNBC, and gastric or GEJ adenocarcinoma, particularly when used with KEYTRUDA® (pembrolizumab) and LIBTAYO® (cemiplimab-rwlc).
Special Instructions
Fresh tissues: specimens may be fixed for 24-72 hours, transferred to 70% ethanol, and stored at 2-8°C for longer periods. Unstained slides require positively charged glass slides to prevent background staining and tissue loss. Specimens should be unbaked.
Limitations
Stated turnaround times are for clinical diagnostic purposes and may vary based on specific biopharma protocol requirements. Final turnaround times 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 (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
FFPE Block
Collection Instructions
Fixative should be at a 20:1 fixative to tissue ratio, 10% neutral buffered formalin for 6-72 hours (48-72 hours preferred). Use refrigerated (NOT FROZEN) gel pack for shipment and separate from the specimen.
Storage Instructions
Store at 15°C to 25°C.
Causes for Rejection
Specimens must be fixed in 10% NBF or B plus. All other fixatives will be rejected.