PD-L1 SP263 FDA for NSCLC

Submitted by Anonymous (not verified) on
Code
APH-PSPP-01AX
Test
Active-Compendium
88360x1
Clinical
Oncology,Pathology
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.
Solid Tumors
Lung
Immunohistochemistry (IHC)
Global
Tech Only
Flag Active
True
Orderable Test Description
<p>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&reg; (atezolizumab) or LIBTAYO&reg; (cemiplimab-rwlc). Results are considered positive for TECENTRIQ when tumors have PD-L1 expression on &ge;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.</p>
Orderable Turn Around Time
1-2 Days
Keywords
PD-L1
PD-L1 SP263
SP263
PD-L1 NSCLC
PD-L1 Tecentriq
Meta Description
The PD-L1 SP263 FDA (TECENTRIQ) for NSCLC test utilizes VENTANA PD-L1 (SP263) to determine PD-L1 tumor cell expression in NSCLC.
Orderable Biomarkers
PD-L1
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["PD-L1"]}}
Keywords string
PD-L1, PD-L1 SP263, SP263, PD-L1 NSCLC, PD-L1 Tecentriq PD-L1 SP263 FDA for NSCLC
Title URL
pd-l1-sp263-fda-for-nsclc
TAT Details

Global: 2 Days
Tech-Only (stain only): 24 Hours

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.