PD-L1 22C3 FDA (KEYTRUDA®) for Gastric/GEA
Companion Diagnostic
PD-L1 22C3 FDA (KEYTRUDA®) for Gastric/GEA 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 formalin-fixed, paraffin-embedded (FFPE) gastric or gastroesophageal junction adenocarcinoma tissue. It aids in identifying patients with metastatic gastric or GEJ cancer for treatment with KEYTRUDA® (pembrolizumab).
Special Instructions
Not provided.
Limitations
For PD-L1 22C3 evaluation, tissue submitted must have 100 viable tumor cells present. Cold pack transport required, ensuring cold pack is not in direct contact with specimen.
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
Slide identifiers should be clearly written and match exactly with specimen ID and requisition labeling.
Storage Instructions
Use cold pack for transport, avoiding direct contact with specimen.
Causes for Rejection
Specimens without 100 viable tumor cells.