PD-L1 22C3 FDA (KEYTRUDA®) for ESCC (Esophageal Squamous Cell Carcinoma)

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Code
APH-PDEP-01AX
Test
Active-Compendium
88360x1
Clinical
Oncology,Pathology
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. For PD-L1 22C3 evaluation, tissue submitted must have 100 viable tumor cells present.
Solid Tumors
Gastroesophageal
Immunohistochemistry (IHC)
Global
Tech Only
Flag Active
True
Orderable Test Description
<p>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) esophageal squamous cell carcinoma (ESCC) and certain other tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying ESCC patients for treatment with KEYTRUDA&reg; (pembrolizumab). KEYTRUDA&reg; is approved for use in some ESCC patients whose tumors express PD-L1 with Combined Positive Score (CPS) &ge;10. For other tumor types with approved indications for this test, please search our Test Menu for 22C3 to see available options.</p>
Orderable Turn Around Time
1-2 Days
Keywords
cervix
22-C3
22 C3
pembro
PDL1
Meta Description
<p>The PD-L1 IHC 22C3 pharmDx test is indicated as an aid in identifying patients with recurrent or metastatic cervical squamous cell cancer for treatment with KEYTRUDA&reg; (pembrolizumab).</p>
Orderable Biomarkers
PD-L1
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["PD-L1"]}}
Keywords string
cervix, 22-C3, 22 C3, pembro, PDL1 PD-L1 22C3 FDA (KEYTRUDA®) for ESCC (Esophageal Squamous Cell Carcinoma)
Title URL
pd-l1-22c3-fda-keytruda-for-escc-esophageal-squamous-cell-carcinoma
TAT Details

Global: 2 Days
Tech-Only (stain only): 24 Hours

Storage and transportation
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection.