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PD-L1 IHC 28-8 pharmDx for Non Small Cell Lung Cancer

More personalized cancer results. One test makes it possible.
PD-L1 IHC 28-8 pharmDx* is now FDA-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 1a highlighted the significant survival and response outcomes from combining OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) 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 YERVOY®.

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

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.

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 pharmDx is for in vitro diagnostic use.

Robust performance

PD-L1 IHC 28-8 pharmDx is FDA-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. M.D. Hellmann, et al. Nivolumab plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer, The New England Journal of Medicine, 2019.
  • PD-L1 IHC 28-8 pharmDx Instructions for Use.
  • YERVOY® package insert. Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA U.S. License No. 1713.
  • OPDIVO® package insert. Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA U.S. License No. 1713.
PD-L1 IHC 28-8 NSCLC pharmDx Intended Use

Intended Use

For in vitro diagnostic use.

PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial carcinoma (UC) tissues using EnVision FLEX visualization system on Autostainer Link 48.

PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity.

Companion Diagnostic Indication

Tumor Indication

PD-L1 Expression Clinical
Cut-Off

Intended Use

NSCLC

≥ 1% tumor cell expression

PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).

PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO®.

PD-L1 expression (≥ 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO®.

PD-L1 expression (≥ 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO®.

See the OPDIVO® and YERVOY® product labels for specific clinical circumstances guiding PD-L1 testing.