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. 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