Methodology: IHC

Clinical Significance:
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), squamous cell carcinoma of the head and neck (SCCHN), and urothelial carcinoma (UC) tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. NSCLC: PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). As a Companion Diagnostic for ≥ 1% tumor cell expression. Non-squamous NSCLC: PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab). SCCHN: PD-L1 expression (≥ 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab). UC: PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO® (nivolumab).

Organ: Lung

Disease State: Non Small Cell Lung Carcinoma (NSCLC)

CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

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** **After sectioning, tissues should be mounted on Dako FLEX IHC microscope slides (Code K8020) or Superfrost Plus slides and then placed in a 58 ± 2 °C oven for 1 hour. Recommended handling and processing conditions are: <30 minutes ischemia time prior to immersion in fixative, and 24- 48 hours fixation time in neutral buffered formalin. Alternative fixatives have not been validated and may give erroneous results. To preserve antigenicity, tissue sections, once mounted on slides, should be stored in the dark at 2-8 °C and stained within 4 months of sectioning. The use of PD-L1 IHC 28-8 pharmDx on decalcified tissues has not been validated and is not recommended.