Code
APH-PGGP-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.
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.
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) gastric carcinoma, gastroesophageal junction carcinoma (GEJ) and esophageal adenocarcinoma (EAC) tissues using EnVision FLEX visualization system on Autostainer Link 48. Although PD-L1 testing has not received the FDA-approval for these tumor types, the CHECKMATE 649 Study showed that OPDIVO® (nivolumab) in combination with chemotherapy demonstrated superior overall survival (OS) and progression-free survival (PFS) when compared to chemotherapy alone. Tissues with PD-L1 Combined Positive Score (CPS) 5 are considered to have PD-L1 expression. Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturers online interpretation training. All PD-L1 IHC test options may be viewed here.</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
PDL1, gastric cancer, GC, gastroesophageal junction carcinoma, GEJ, esophageal adenocarcinoma, EAC, PD1, PD L1, PD-L1, CDx, cdx PD-L1 28-8 (OPDIVO®) for Gastric/GEJ/EAC
Title URL
pd-l1-28-8-opdivo-for-gastric-gej-eac