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PD-L1 by IHC, 22C3, Keytruda®

CPT 88360
Synonyms

Pembrolizumab; Programmed Death Ligand 1

Test Details

Cancer Type

Breast, Cervical, Gastric, Head and neck, Lung, Non-small cell lung cancer, Squamous cell carcinoma of the head and neck (SCCHN)

Technology Used

IHC

Turnaround Time

2 - 3 days

Use

The Dako PD-L1 22C3 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, adenocarcinoma, cervical cancer, esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), and triple-negative breast cancer (TNBC) tissue samples using the Dako Autostainer Link 48 Platform.

Methodology

Immunohistochemistry (IHC) using Dako Autostainer Link 48 platform.

Specimen Requirements

Information on collection, storage, and volume

Specimen

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

Volume

At least three unstained slides sectioned at 4 to 5 microns. Five slides are ideal.

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

Insufficient tissue; inappropriate tissue source; incorrect specimen type; we cannot accept nasopharyngeal carcinoma and primary salivary gland carcinoma specimen. Cytology samples are accepted for NSCLC but rejected for all other indications (gastric, cervical, HNSCC, ESCC).

Collection

Paraffin block or unstained slides. Send slides within 6 months of sectioning.