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PD-L1 IHC 22C3 pharmDx is intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tissues to identify patients for eligibility for treatment with KEYTRUDA® (pembrolizumab). Tumor Indications include: ￼non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC), cervical cancer, urothelial carcinoma and head and neck squamous cell carcinoma (HNSCC). PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. A positive score is TPS ≥ 1%. PD-L1 protein expression in gastric or GEJ adenocarcinoma, ESCC, cervical cancer, urothelial carcinoma and HNSCC is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. Postivie scores are CPS≥1 for GEJ, cervical cancer, and HNSCC, and CPS≥10 for ESCC and urothelial carcinoma.
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
**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.
To preserve antigenicity, tissue sections, once mounted on slides, should be held in the dark at 2-8 °C (preferred), or at room temperature up to 25 °C. Slide storage and handling conditions should not exceed 25 °C at any point post-mounting to ensure tissue integrity and antigenicity.
Cut Section Storage Recommendations
NSCLC: sections must be stained within 6 months when stored at 2-8 ºC (preferred), or at 25 ºC.
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma: sections must be stained within 5 months when stored at 2-8 ºC (preferred), or at 25 ºC.
ESCC: sections must be stained within 4.5 months when stored at 2-8 °C (preferred), or within 1 month when stored at 25 °C.
Cervical Cancer: sections must be stained within 5 months when stored at 2-8 ºC (preferred), or within 1 month when stored at 25 ºC.
Urothelial Carcinoma: sections must be stained within 1 month when stored at 2-8 °C (preferred), or at 25 °C.
HNSCC: sections must be stained within 6 months when stored at 2-8 °C (preferred), or within 4 months when stored at 25 °C.