Code
APH-PLTP-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 22C3 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 22C3 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>PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) triple-negative breast cancer (TNBC) tissue using EnVision FLEX visualization system on Autostainer Link 48. This test is indicated as an aid in identifying TNBC patients for treatment with KEYTRUDA® (pembrolizumab). Tissues with PD-L1 Combined Positive Score (CPS) ≥10 are considered positive. Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturers online interpretation training. All PD-L1 IHC test options may be viewed here.</p>
Orderable Turn Around Time
1-2 Days
Keywords
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["PD-L1"]}}
Keywords string
PDL1, triple neg, triple negative breast cancer, HER2-, HR-, ER-, PR-, PgR-, triple-neg, PD1, PD L1, CDx, cdx PD-L1 22C3 FDA (KEYTRUDA®) for TNBC (Breast)
Title URL
pd-l1-22c3-fda-keytruda-for-tnbc-breast
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.