PD-L1 FDA (KEYTRUDA®) for Urothelial
Methodology
Immunohistochemistry (IHC)
Test Description and clinical significance
Disease:
Urothelial Carcinoma
Detection of PD-L1 upregulation in urothelial carcinoma is a biomarker for response to anti-PD-1 therapy. PD-L1 expression in urothelial carcinoma is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages*) divided by the total number of viable tumor cells, multiplied by 100.
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)
88360
New York Approved
NO
TAT
2 Days
*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.
