Code
APH-PLDP-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 LDT evaluation, tissue submitted must have 100 viable tumor cells present.
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 LDT evaluation, tissue submitted must have 100 viable tumor cells present.
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. 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.</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
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.