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PD-L1 IHC 28-8 pharmDx for Gastric Cancer

More personalized cancer results. One test makes it possible.
Product Information
PD-L1 IHC 28-8 pharmDx® is now MHLW-approved as an aid in identifying Gastric cancer patients for the combo immunotherapy OPDIVO® (nivolumab) plus fluoropyrimidine and platinum-containing chemotherapy
Agilent Dako
Demonstrated clinical results

CHECKMATE-649 is a Phase 3, randomized, multi-center, open-label study in patients with previously untreated, non-HER2-positive, advanced or metastatic gastric cancer whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

CHECKMATE-649 results highlight overall survival (OS) benefit from OPDIVO® (nivolumab) in combination with fluoropyrimidine and
platinum-containing chemotherapy in non-HER2-positive patients whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

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

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

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PD-L1 IHC 28-8 pharmDx Gastric cancer 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 gastric cancer.

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PD-L1 IHC 28-8 pharmDx Gastric cancer 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

Contact your local sales representative.

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Product Information Product Information​

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

PD-L1 IHC 28-8 pharmDx
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-649.
  • 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 Gastric cancer pharmDx 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 non-small cell lung cancer [NSCLC] patients, head-and-neck cancer patients, and gastric 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 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 or gastric cancer 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 28-8 pharmDx, refer to the packaging insert of the drugs, and appropriately judge the adequacy of administration.

See the OPDIVO® product label for specific clinical circumstances guiding PD-L1 testing