PD-L1 22C3 FDA for NSCLC
Also known as: Formerly named PD-L1 22C3 FDA (KEYTRUDA®) for NSCLC
Use
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab) or LIBTAYO® (cemiplimab-rwlc). Results are considered positive for KEYTRUDA when Tumor Proportion Score (TPS) is ≥1% and for LIBTAYO when TPS is ≥50%.
Special Instructions
Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer online interpretation training.
Limitations
The assay is intended for formalin-fixed, paraffin-embedded (FFPE) tissue and may have limitations outside of the specified specimen type. Accurate results depend on the quality of the tissue samples and adherence to proper staining protocols.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
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 (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns). Block and slide identifiers should match the specimen ID.
Storage Instructions
Use cold pack for transport, ensuring no direct contact with specimen.