PD-L1 22C3 FDA for NSCLC
Also known as: Formerly named PD-L1 22C3 FDA (KEYTRUDA®) for NSCLC
Companion Diagnostic
PD-L1 22C3 FDA for NSCLC is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
PD-L1 expression is assessed in formalin-fixed, paraffin-embedded (FFPE) tumor tissue using immunohistochemistry (IHC), with results reported as Tumor Proportion Score (TPS), representing the percentage of viable tumor cells showing membrane staining for PD-L1; this test is used to support treatment decision-making involving therapies targeting the PD-1/PD-L1 pathway, with interpretation dependent on clinical context and established treatment guidelines.
Special Instructions
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen; if submitting slides, include one (1) unstained slide for H&E staining and two to three (2–3) positively charged unstained slides cut at 4–5 microns, ensure proper fixation using 10% neutral buffered formalin and avoid alternative fixatives such as zinc or mercury-based solutions, and confirm that block and slide identifiers match the specimen ID and requisition, noting that stain-only (technical-only) testing may be available for clients who have completed required assay-specific training.
Limitations
This assay is validated for use with formalin-fixed, paraffin-embedded (FFPE) tissue and may not be suitable for other specimen types; results depend on specimen quality, including adequate tumor content, proper fixation, and adherence to staining protocols, and pre-analytic variables such as fixation time and tissue handling may impact staining performance and interpretation, with PD-L1 expression potentially varying within a tumor and across specimens, requiring results to be interpreted in conjunction with clinical findings and other diagnostic information.
FDA ApprovedNew York ApprovedCompanion Diagnostic
Methodology
Immunoassay (IHC)
Biomarkers
PD-L1
Protein
LOINC Codes
- 83054-7 - PD-L1 by 22C3 Tiss ImStn-Imp
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
FFPE tissue block preferred; alternatively, unstained slides as specified below
Minimum Volume
One (1) FFPE block or one (1) unstained slide for H&E plus two to three (2–3) unstained slides for testing
Collection Instructions
A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred; alternatively, submit one (1) unbaked, unstained slide for H&E staining (required) and two to three (2–3) positively charged unstained slides cut at 4–5 microns, ensuring block and slide identifiers match the specimen ID.
Storage Instructions
Transport with a cold pack, ensuring no direct contact with the specimen and maintaining appropriate temperature conditions during transit