Code
APH-PDDP-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 for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 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.
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.
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) cervical squamous cell carcinoma tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying patients with recurrent or metastatic cervical cancer for treatment with KEYTRUDA® (pembrolizumab). PD-L1 22C3 test for other indications may be viewed. Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturers online interpretation training.</p>
Orderable Turn Around Time
1-2 Days
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["PD-L1"]}}
Keywords string
cervix, 22-C3, 22 C3, pembro, PDL1, CPS, combined positive scoring PD-L1 22C3 FDA (KEYTRUDA®) for Cervical
Title URL
pd-l1-22c3-fda-keytruda-for-cervical
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.