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  4. Key benefits of PD-L1 IHC 22C3 pharmDx

Key benefits of PD-L1 IHC 22C3 pharmDx

FDA-approved
  • KEYNOTE-001 NSCLC clinical trial study determined PD-L1 status in patients using the validated PD-L1 IHC 22C3 pharmDx assay
Proven sensitivity
  • Assessment of PD-L1 expression demonstrated staining across the dynamic range of 0-100% positive tumor cells and 0-3+ staining intensity
  • Approximately 25% of the NSCLC patients tested with PD-L1 IHC 22C3 pharmDx were PD-L1 positive (≥ 50%) in KEYNOTE-001
Proven specificity
  • PD-L1 IHC 22C3 pharmDx includes the proprietary Mouse Monoclonal Anti-PD-L1, Clone 22C3
  • Clone 22C3 does not cross-react with human PD-L2 (Programmed Death Ligand 2) protein
  • Clone 22C3 binds to PD-L1 on the cell membrane of tumor cells, immune cells, and cells of epithelial origin
Clinically validated and reproducible
  • PD-L1 IHC 22C3 pharmDx provides reproducible results, without the extensive burden of validation that lab-developed tests require
  • PD-L1 IHC 22C3 pharmDx includes the only validated scoring guidelines relevant for KEYTRUDA
Automated method for operational efficiency
  • PD-L1 IHC 22C3 pharmDx is a standardized IHC assay with ready-to-use components for 50 tests in one kit
  • Designed for use on Autostainer Link 48
  • Results can be available within one working day

(1) Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. New Eng J Med 2015;372:2018-28.

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Product information

Product details, specification sheet and safety data sheet (SDS).

PRODUCT DETAILS

Intended Use

For in vitro diagnostic use

PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. 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. The specimen should be considered PD-L1 positive if TPS ≥ 50% of the viable tumor cells exhibit membrane staining at any intensity.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab).