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PD-L1 IHC 28-8 pharmDx for Muscle Invasive Urothelial Carcinoma (MIUC)

More personalized cancer results. One test makes it possible.
PD-L1 IHC 28-8 pharmDx is now CE-IVD marked to identify MIUC patients for the adjuvant treatment with OPDIVO (nivolumab)
Agilent Dako
Demonstrated clinical results

CHECKMATE-274

  • Phase 3, randomized, double-blind, multicenter study of adjuvant nivolumab versus placebo in subjects with invasive MIUC that are at high-risk of recurrence after undergoing
    radical resection.
  • The study results highlight an enhanced disease-free survival (DFS) benefit to the patient from OPDIVO (nivolumab) treatment.
Product Information
Demonstrated clinical results
PD-L1 IHC 28-8 pharmDx MIUC Interpretation Manual PD-L1 IHC 28-8 pharmDx MIUC Interpretation Manual

Refer to the Interpretation Manual to review validated scoring guidelines that can aid in the identification of MIUC patients for the adjuvant treatment
with OPDIVO.

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

Get the training that may help you accurately evaluate and score
PD-L1 expression in patients with UC (including MIUC).

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PD-L1 IHC 28-8 pharmDx MIUC Brochure PD-L1 IHC 28-8 pharmDx MIUC 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 safety data sheet (SDS).

PD-L1 IHC 28-8 pharmDx SDS
Robust performance

PD-L1 IHC 28-8 pharmDx is CE-IVD marked 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 138 unique cases of human UC FFPE specimens staged III to IV using a manufactured production lot. Assessment of PD-L1 expression demonstrated staining across a range of 0-90% positive tumor cells and 0-3 staining intensity
Reproducibility
  • Testing was performed at three external sites to evaluate inter-site (86.9% OA), intra-site (92.9% OA), inter-observer (92.2% OA), and intra-observer (96.3% OA) reproducibility at the ≥ 1% PD-L1 expression cutoff

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

PT100/PT101/PT200

PT109
References
  • Bajorin D. F., Witjes A., et al. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N. Engl. J. Med. 2021, 384(22), 2102-2114.
  • 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.

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-squamous non-small cell lung cancer (nsNSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), melanoma, gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and esophageal carcinoma tissues using EnVision FLEX visualization system on Autostainer Link 48.

PD-L1 protein expression in nsNSCLC, SCCHN, UC, muscle invasive urothelial carcinoma (MIUC), melanoma, and esophageal squamous cell carcinoma (ESCC) is determined by using % tumor cell expression, which is the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity.

PD-L1 protein expression in gastric adenocarcinoma, GEJ adenocarcinoma, and esophageal adenocarcinoma 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.

Companion Diagnostic Indications

Tumor Indication

PD-L1 Expression Clinical
Cut-Off

Intended Use

MIUC

≥ 1% tumor cell expression

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

ESCC

≥ 1% tumor cell expression

PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying ESCC patients for treatment with OPDIVO® (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy or OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).

Gastric, GEJ, or Esophageal Adenocarcinoma

CPS ≥ 5

PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying gastric, gastroesophageal junction, or esophageal adenocarcinoma patients for treatment with OPDIVO® (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy.

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

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® (nivolumab).

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

PD-L1 expression (≥ 1% or ≥ 5% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in melanoma may be used as an aid in the assessment of patients for whom OPDIVO® (nivolumab) and YERVOY® (ipilimumab) combination treatment is being considered.

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

 

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