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Alternative Name
Formerly named PD-L1 22C3 FDA (KEYTRUDA®) for NSCLC
Methodology
Immunohistochemistry (IHC)
Test Description

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 manufacturer’s online interpretation training.

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

Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

CPT Code(s)*
88360 x 1
Turnaround Time

Global: 48 hours, Tech-Only (stain only): 24 hours

New York Approved
Yes
Level of Service
Global
Stain Only

*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.