Methodology: IHC

Clinical Significance:
PD-L1 IHC 28-8 pharmDx is the only FDA-approved complementary test for PD-L1 expression associated with enhanced survival with OPDIVO® (nivolumab) for non-squamous NSCLC. PD-L1 IHC 28-8 pharmDx is a complementary diagnostic to assess NSCLC patients for OPDIVO® (nivolumab). Per the Dako SK005 Data Sheet, “OPDIVO® (nivolumab) is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway mediated inhibition of the immune response, including the anti-tumor immune response.” PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity, and will be scored according to the guidelines provided in the package insert and Interpretive Manual provided by Dako. Subcellular Localization: Membranous

Organ: Lung

Disease State: Non Small Cell Lung Carcinoma (NSCLC)

CPT Code(s): 88360 (reference only; CPTs may vary)

Turnaround Time: Within 1-2 business days of receipt

Schedule: Monday - Friday

Specimen Requirements:
• Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 2 unstained slides for each test requested plus 3-4 additional unstained slides cut at 4µm