PD-L1 28-8 FDA for NSCLC

Submitted by Anonymous (not verified) on
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.
Solid Tumors
Lung
Immunohistochemistry (IHC)
Global
Tech Only
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&reg; (nivolumab) or OPDIVO in combination with YERVOY&reg; (ipilimumab). Results are considered positive for either treatment when PD-L1 is expressed in &ge;1% of tumor cells (TC). Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer&trade;s online interpretation training. Please note: PD-L1 testing is not required for use of OPDIVA&reg; 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
1-2 Days
Keywords
PD-L1
PD-L1 28-8
28-8
PD-L1 NSCLC
PD-L1 Opdvio
PD-L1 Yervoy
Meta Description
The PD-L1 28-8 FDA for NSCLC test utilizes 28-8 pharmDx to determine PD-L1 tumor cell expression in NSCLC.
Orderable Biomarkers
PD-L1
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
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.