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PD-L1 SP263 FDA for NSCLC
- Immunohistochemistry (IHC)
The VENTANA 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. Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturers online interpretation training.
Turnaround time
Global: 2 Day, Tech-Only (stain only): 1 Day
Level of Service
- Global
- Technical Only
New York Approved: Yes
Specimen Requirements
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. For PD-L1 SP263 evaluation, tissue submitted must have 50 viable tumor cells present.
Storage and Transportation
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.
CPT Code(s)*
88360x1
*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.
Last Updated: January 22, 2025