Methodology: IHC

Clinical Significance:
PD-L1 IHC 22C3 pharmDx is the first and only FDA-approved companion diagnostic to assess NSCLC patients for eligibility for treatment with KEYTRUDA® (pembrolizumab).  Per the Dako SK006 Data Sheet, “KEYTRUDA® (pembrolizumab) is a humanized monoclonal antibody that binds to the 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 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA®”. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining. A TPS ≥ 50% is positive for PD-L1.

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