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Methodology
Immunohistochemistry (IHC)
Test Description

PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissues using EnVision FLEX visualization system on Autostainer Link 48. Tissues with ≥1% tumor cells (TC) are considered positive. PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in NSCLC is associated with an overall survival benefit from OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). The detection of PD-L1 expressing tumor cells in non-squamous NSCLC patients may also indicate an enhanced survival benefit to OPDIVO®.

Specimen Requirements
  • A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or
  • One (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 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)*
88360x1
New York Approved
No
Level of Service
Global
Stain Only
Turnaround Time

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

References
  1. PD-L1 IHC 28-8 pharmDx [package insert]. Carpinteria, CA: Dako;
  2. OPDIVO® (nivolumab) [package insert]. Princeton, NJ: Bristol Myers Squibb;

*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.