Code
APH-PDNX-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 28-8 evaluation, tissue submitted must have at least 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 28-8 evaluation, tissue submitted must have at least 100 viable tumor cells present.
Flag Active
True
Orderable Test Description
<p>PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) or OPDIVO in combination with YERVOY® (ipilimumab). Results are considered positive for either treatment when PD-L1 is expressed in ≥1% of tumor cells (TC). Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer™s online interpretation training. Please note: PD-L1 testing is not required for use of OPDIVA® in non-squamous NSCLC, head and neck squamous cell carcinoma or urothelial carcinoma, but may provide physicians more information and inform patient dialogue.</p>
Orderable Turn Around Time
Global: 2 Day, Tech-Only (stain only): 1 Day
Keywords
Extra Note
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.
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["PD-L1"]}}
Keywords string
PD-L1, PD-L1 28-8, 28-8, PD-L1 NSCLC, PD-L1 Opdvio, PD-L1 Yervoy PD-L1 28-8 FDA for NSCLC
Title URL
pd-l1-28-8-fda-for-nsclc