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PD-L1 by IHC, Opdivo®

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Synonyms

Nivolumab; Programmed Death Ligand 1

Test Details

Cancer Type

Bladder, Lung, Non-small cell lung cancer, Squamous cell carcinoma of the head and neck (SCCHN)

Technology Used

IHC

Turnaround Time

2 - 4 days

Use

The Dako PD-L1 28-8 pharmDx™ kit is a qualitative assay intended for use in the detection of PD-L1 in formalin-fixed, paraffin-embedded (FFPE) formalin-fixed, paraffin embedded (FFPE) in non-small-cell lung cancer, urothelial carcinoma (bladder cancer), and head and neck squamous cell carcinoma (HNSCC) tissue samples using the Dako Autostainer Link 48 Platform.

Methodology

Immunohistochemistry (IHC)

Specimen Requirements

Information on collection, storage, and volume

Specimen

Tissue

Volume

One formalin-fixed paraffin-embedded (FFPE) tissue block or five unstained positively charged slides sectioned from FFPE tissue block at 4 to 5 microns.

Container

Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides

Storage Instructions

Room temperature

Causes for Rejection

Insufficient tissue; tumor other than non-squamous non-small-cell lung cancer

Collection

Tissue should be fixed in 10% neutral buffered formalin for no more than 72 hours, embed in paraffin. Alternative fixatives have not been validated and may give erroneous results.