PD-L1, 22C3 FDA (KEYTRUDA®) for Gastric/GEA

Methodology

Immunohistochemistry (IHC)

Test Description

PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) gastric or gastroesophageal junction adenocarcinoma (GEJ, GEA) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying patients with metastatic gastric or GEJ cancer for treatment with KEYTRUDA® (pembrolizumab).
For non-small cell lung carcinoma (NSCLC) and other non-gastric cancers, please order PD-L1, 22C3 FDA (KEYTRUDA®).

Specimen Requirements

• A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type
or
• One (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered
• Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.

Storage & Transportation

Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

CPT Code(s)*

88360 x 1

Level of Service

  • Global   

Turnaround Time

48 hours


*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.


 

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