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PD-L1 IHC 28-8 pharmDx for NSCLC

More personalized cancer results. One test makes it possible.
PD-L1 IHC 28-8 pharmDx* is now MHLW-approved as a companion diagnostic to aid in identifying non-small cell lung cancer (NSCLC) patients for the combo immunotherapy OPDIVO®(nivolumab) plus YERVOY®(ipilimumab).
Agilent Dako
 
Demonstrated clinical results

CHECKMATE-227 was a Phase III, randomized, multi-center, multi-cohort, open-label study in patients who had no prior anti cancer therapy with metastatic NSCLC. Part 1a of the study investigated patients with PD-L1 expression level < 1%, who were previously untreated for advanced disease. PD-L1 IHC 28-8 pharmDx was the only test used for PD-L1 expression analysis across all histology in non-squamous and squamous NSCLC.

CHECKMATE-227, Part 1b highlighted the median Progression free survival and hazard ratio outcomes from combining OPDIVO® (nivolumab) plus Chemotherapy as a first line treatment for metastatic NSCLC patients whose tumors exhibited PD-L1 expression <1%.

Clinical study results
 
PD-L1 IHC 28-8 pharmDx NSCLC Interpretation Manual PD-L1 IHC 28-8 pharmDx NSCLC Interpretation Manual

Refer to the NSCLC Interpretation Manual to review validated scoring guidelines that can aid in the identification of NSCLC patients for treatment with OPDIVO® and chemotherapy.

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PD-L1 IHC 28-8 pharmDx NSCLC Interpretation Training Program PD-L1 IHC 28-8 pharmDx NSCLC Interpretation Training Program

Get the training that may help you accurately evaluate and score PD‑L1 expression in patients with NSCLC

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PD-L1 IHC 28-8 pharmDx NSCLC Brochure PD-L1 IHC 28-8 pharmDx NSCLC Brochure

PD-L1 IHC 28-8 pharmDx has been analytically validated for specificity, sensitivity, and reproducibility, and shows high clinical utility across various indications.

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Want to hear more about PD-L1 IHC 28-8 pharmDx? PD-L1 IHC 28-8 pharmDx workflow teaser image

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Product Information Product Information​

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

PD-L1 IHC 28-8 pharmDx

* PD-L1 IHC pharmDx is for in vitro diagnostic use.

 
Robust performance

PD-L1 IHC 28-8 pharmDx is MHLW-approved and fully validated with analytical performance having met all pre-determined acceptance criteria for sensitivity, specificity and precision.

Selected analytical validation parameters Description
Specificity
  • Demonstrated specificity to clone 28-8 for PD-L1 detection.
  • Detection in normal tissues is restricted to immune cells and infrequently the cells of epithelial origin.
  • PD-L1 primary antibody displays no cross-reactivity for PD-L2.
Sensitivity
  • Analytical sensitivity of PD-L1 IHC 28-8 pharmDx was tested on 186 unique cases of human NSCLC FFPE specimens staged I to IV using a manufactured production lot. Assessment of PD-L1 expression demonstrated staining across a range of 0–100% positive tumor cells and 0–3 staining intensity.
Repeatability
  • Repeatability testing of inter-instrument, inter-operator, inter-day, inter-lot and intra-run performance.
  • ≥ 98.1% OA for ≥ 1% expression level.
Reproducibility
  • Reproducibility testing of inter-site assay, intra-site assay, inter-observer and intra-observer.
  • 97.9% is a point estimate OA for ≥ 1% expression level.

OA = Overall Agreement

 
Order information
Product Code
PD-L1 IHC 28-8 pharmDx SK005

Required but not included in kit:

Autostainer Link 48

EnVision FLEX Wash Buffer, 20x

EnVision FLEX Hematoxylin (Link)

PT Link

PT Link Rinse Station

  

AS480

K8007

K8008

PT101 / PT200

PT109
 
References
  • CHECKMATE-227. Hellmann M. D., Paz-Ares L., et al. Nivolumab plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer. N. Engl. J. Med. 2019, 381, 2021-2031.
  • PD-L1 IHC 28-8 pharmDx Instructions for Use.
  • OPDIVO® package insert. Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA U.S. License No. 1713.
Review the PD-L1 IHC 28-8 pharmDx NSCLC Intended Use
Intended use
 

Intended Use

For in vitro diagnostic use.

To measure the proportion of PD-L1 expression in cancer tissue or cells

  • Indication as an aid for proper administration of nivolumab [recombinant] in NSCLC patients and head-and-neck cancer patients
  • Indication as an aid for proper administration of nivolumab [recombinant] and ipilimumab combination in melanoma patients

It is desirable to measure PD-L1 expression by PD-L1 IHC 28-8 kit in determining whether or not the following drugs can be administered.

  • Nivolumab [recombinant] for patients with non-squamous NSCLC or head-and-neck cancer who have been treated with chemotherapy previously
  • Combination therapy of nivolumab [recombinant] and chemotherapy for NSCLC patients who have not been treated with chemotherapy
  • Combination therapy of nivolumab [recombinant] and ipilimumab for melanoma patients

If it is not possible to measure PD-L1 expression using PD-L1 IHC 28-8pharmDx kit, refer to the package insert of the drugs and appropriately judge the administration's adequacy.