Code
APH-PSPP-01AX
Test
Active-Compendium
88360x1
Clinical
Oncology,Pathology
<b>Preferred specimen (FFPE block):</b><br>
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen type. Use 10% NBF fixative; do not use zinc or mercury fixatives.<br>
<b>If submitting slides (instead of a block):</b><br>
Submit the following. All slides cut at 4-5 microns. Please use positively-charged slides and 10% NBF fixative.<br>
<span style="margin-left: 20px;">H&E slide: One (1) unbaked, unstained slide for H&E staining (required)</span><br>
<span style="margin-left: 20px;">Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered</span><br>
<b>PD-L1 SP263 evaluation:</b><br>
Tissue submitted must have >100 viable tumor cells present.<br>
<b>Specimen identification:</b><br>
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen type. Use 10% NBF fixative; do not use zinc or mercury fixatives.<br>
<b>If submitting slides (instead of a block):</b><br>
Submit the following. All slides cut at 4-5 microns. Please use positively-charged slides and 10% NBF fixative.<br>
<span style="margin-left: 20px;">H&E slide: One (1) unbaked, unstained slide for H&E staining (required)</span><br>
<span style="margin-left: 20px;">Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered</span><br>
<b>PD-L1 SP263 evaluation:</b><br>
Tissue submitted must have >100 viable tumor cells present.<br>
<b>Specimen identification:</b><br>
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
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® (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.</p>
Orderable Turn Around Time
1-2 Days
Keywords
Orderable Biomarkers
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
Slides may be stored at room temperature; transport with cold pack, making sure cold pack is not in direct contact with specimen.
NYS Clients: Please provide Date and Time of Collection.