PDL SP263
Alternative name:
IMFINZI
Methodology
Immunohistochemistry (IHC)
Test Description and clinical significance
Disease:
non-small cell lung cancer (NSCLC)
PD-L1 (SP263) assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP263 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue on a VENTANA BenchMark ULTRA instrument. PD-L1 (SP263) is indicated as an aid in identifying NSCLC patients for treatment with TECENTRIQ® (atezolizumab) or LIBTAYO® (cemiplimab-rwlc). Results are considered positive for TECENTRIQ when tumors have PD-L1 expression on ≥ 1% of tumor cells (TC) at any intensity and positive for LIBTAYO when tumors have PD-L1 expression on ≥50% of tumor cells (TC) at any intensity.
Specimen Requirements
Collection:
FFPE/un-stained slides/Fresh tissue in formalin, For PD-L1 SP263 evaluation, tissue submitted must have ≥50 viable tumor cells present.
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.
