Alternative Name
PD-L1, 28-8 FDA (OPDIVO®)
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-squamous non-small cell lung cancer (NSCLC) and melanoma tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity.

Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer’s online interpretation training.

Clinical Significance

Testing is not required for use of OPDIVO® in NSCLC or melanoma but may provide physicians more information and inform patient dialogue. In non-squamous NSCLC, PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx may be associated with enhanced survival from OPDIVO®. In melanoma, PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx is correlated with the magnitude of the treatment effect on progression-free survival (PFS) from OPDIVO®. Patients receiving OPDIVO® in combination with ipilimumab derived similar PFS benefit regardless of PD-L1 status as determined by the PD-L1 IHC 28-8 pharmDx test.

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

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.