Code
APH-PLDP-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 LDT 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 LDT 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>Programmed cell death ligand 1 (PD-L1) is a transmembrane protein involved in cellular and humoral immune response regulation. PD-L1 expression has been found in a variety of cancers expressed on tumor and/or immune cells. This lab developed test uses the Zeta PD-L1 monoclonal antibody clone ZR3 to detect PD-L1 in formalin-fixed paraffin-embedded tissues. The utility of PD-L1 (ZR3) in predicting the response to anti-PD-1/PD-L1 has not been determined and no standardized scoring criteria currently exist. For therapies and indications that have an FDA-approved PD-L1 companion diagnostic, it is recommended to use the associated FDA approved PD-L1 test. All PD-L1 IHC test options may be viewed here. Scoring for this test is called Total PD-L1 Expression and is calculated by dividing the sum of the number of staining tumor cells and inflammatory cells by the total number of viable tumor cells. Results are reported as detected if the total score is a 1 and not detected if</p>
Orderable Turn Around Time
1-2 Days
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["PD-L1"]}}
Keywords string
PD-L1, PD-L1 LDT, ZR3 PD-L1 LDT
Title URL
pd-l1-ldt
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.