PD-L1 22C3 FDA (KEYTRUDA®) for Cervical
Companion Diagnostic
PD-L1 22C3 FDA (KEYTRUDA®) for Cervical 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 a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) cervical squamous cell carcinoma tissue using EnVision FLEX visualization system on Autostainer Link 48. It is indicated as an aid in identifying patients with recurrent or metastatic cervical cancer for treatment with KEYTRUDA® (pembrolizumab).
Special Instructions
Not provided.
Limitations
The test requires the presence of 100 viable tumor cells in the submitted tissue. The assay is qualitative and utilizes a specific monoclonal antibody clone.
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 (FFPE) tissue block is preferred or one unbaked, unstained slide for H&E staining and two to three positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered.
Storage Instructions
Use cold pack for transport, ensuring it is not in direct contact with the specimen.