PDL 28-8
Alternative name:
PD-L1 28-8 (OPDIVO®)
Methodology
Immunohistochemistry (IHC)
Test Description and clinical significance
Disease:
Gastric/GEJ/Esophageal Adenocarcinoma
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.
Specimen Requirements
Collection:
FFPE/un-stained slides/Fresh tissue in formalin
Stability:
Room temperature
Unacceptable Conditions:
Unlabeled specimen/specimen left unfixed
for extended periods
Storage & Transport
Room Temperature
CPT(s)
88360x1
New York Approved
YES
TAT
72 hours
*The CPT codes provided are for informational purposes only and are based on AMA guidelines The billing party is solely responsible for correct CPT coding.
