PD-L1 SP263 FDA for NSCLC
Companion Diagnostic
PD-L1 SP263 FDA for NSCLC is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
The VENTANA PD‑L1 (SP263) assay is a qualitative immunohistochemical test using rabbit monoclonal anti‑PD‑L1 clone SP263 for formalin‑fixed, paraffin‑embedded (FFPE) non‑small cell lung cancer (NSCLC) tissue. It aids in assessing PD‑L1 expression to help identify NSCLC patients eligible for treatment with TECENTRIQ® (atezolizumab) when tumor cell PD‑L1 expression is ≥1%, and for LIBTAYO® (cemiplimab‑rwlc) when PD‑L1 expression is ≥50% on tumor cells at any intensity.
Special Instructions
Not provided.
Limitations
Not provided.
FDA ApprovedNew York ApprovedCompanion Diagnostic
Methodology
Immunoassay (IHC)
Biomarkers
PD‑L1
Protein
LOINC Codes
- 99064-8 - PD-L1 by SP263 Tiss Doc
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
FFPE tissue block preferred, or one unbaked unstained slide for H&E (required) plus two to three positively charged unstained slides cut at 4‑5 microns; tissue must contain 50 viable tumor cells
Storage Instructions
Use cold pack for transport, ensuring cold pack not in direct contact with specimen; NYS clients provide date and time of collection