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PD-L1 22C3 FDA for NSCLC
- Immunohistochemistry (IHC)
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) non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. 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%. PD-L1 22C3 tests for other indications may be viewed here. Stain-only (tech-only) testing is available to clients who have completed the test kit manufacture™ online interpretation training.
Turnaround time
Global: 2 Day, Tech-Only (stain only): 1 Day
Level of Service
- Global
- Technical Only
New York Approved: Yes
Specimen Requirements
A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type 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) for each test/antibody ordered. Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Storage and Transportation
Storage & Transportation: Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection.
CPT Code(s)*
88360 x 1
*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.
Last Updated: January 22, 2025