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HelpTest ID 88725 PD-L1 (B7-H1, CD274), Semi-Quantitative Immunohistochemistry, Manual
Useful For
Identification of neoplasms expressing programmed cell death 1 ligand 1
Testing Algorithm
This test is intended for prognostic purposes and will provide an interpretive report. A concurrent order for 70012 / Pathology Consultation is not required.
Method Name
Immunohistochemistry
Reporting Name
PD-L1, Semi-Quant IHC, ManualSpecimen Type
TissueSpecimen Type: Formalin-fixed, paraffin-embedded tissue block; or 3 unstained glass, “positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue
Container/Tube: Pathology Packaging Kit (T554)
Collection Instructions: Attach the green pathology address label included in the kit to the outside of the transport container.
Additional Information:
1. A pathology/diagnostic report and a brief history are required.
2. One slide will be stained with hematoxylin and eosin and retained.
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Tissue | Ambient (preferred) | |
| Refrigerated | ||
Clinical Information
Programmed cell death 1 ligand 1 (PD-L1), also known as B7 homolog 1 (B7-H1) or CD274, is a transmembrane protein involved in the regulation of cell-mediated immune responses through interaction with the receptor programmed death-1 (PD-1). PD-L1 has been identified as both a prognostic and theranostic marker in a variety of neoplasms. Overexpression of PD-L1 has been observed in carcinomas of the bladder, lung, thymus, colon, pancreas, ovary, breast, kidney, and in melanoma and glioblastoma.
Cautions
The predictive value of programmed cell death 1 ligand 1 (PD-L1) immunohistochemistry for tumor therapy decisions is not established. Preclinical studies suggest that positive PD-L1 immunohistochemistry in tumor cells may predict tumor response to therapy with immune checkpoint inhibitors. This result should not be used as the sole factor in determining treatment, as other factors (eg, tumor mutation burden and microsatellite instability) have also been studied as predictive markers.
This test has been validated for nondecalcified paraffin-embedded tissue specimens fixed in 10% neutral buffered formalin. This assay has not been validated on tissues subjected to the decalcification process or use of alternative fixatives for bone and bone marrow specimens or cell blocks.
Day(s) Performed
Monday through Friday
Report Available
5 daysPerforming Laboratory
Mayo Medical Laboratories in Rochester
Test Classification
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
88360