PD-L1 22C3 FDA (KEYTRUDA®) for TNBC (Breast)
Companion Diagnostic
PD-L1 22C3 FDA (KEYTRUDA®) for TNBC (Breast) is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
PD-L1 IHC 22C3 pharmDx is used to detect PD-L1 protein in FFPE triple-negative breast cancer tissue. It aids in identifying TNBC patients for treatment with KEYTRUDA® (pembrolizumab). A CPS ≥10 is considered positive.
Special Instructions
Not provided.
Limitations
The test requires tissue with at least 100 viable tumor cells. Accurate interpretation depends on proper fixation and processing.
FDA ApprovedNew York ApprovedCompanion Diagnostic
Methodology
Immunoassay (IHC)
Biomarkers
PD-L1
Protein
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
A formalin-fixed, paraffin-embedded tissue block is preferred, or provide unstained slides. Tissue must have 100 viable tumor cells.
Storage Instructions
Use cold pack for transport, ensuring it does not contact the specimen.