Programmed Death-Ligand 1 (PD-L1) (22C3), Semi-Quantitative Immunohistochemistry, Manual
Use
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 protein-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 urinary bladder, lung, gastric and gastroesophageal junction, thymus, colon, pancreas, ovary, breast, kidney, and in melanoma and glioblastoma.
Special Instructions
In patients with specific tumor types, programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) is indicated to predict response to treatment with PD-L1 inhibitors. The specific PD-L1 clone, scoring method, and eligibility requirements depend on the tumor type, stage of malignancy, previous treatment outcomes, and specific PD-L1 inhibitor under consideration.
Limitations
Preclinical studies suggest that positive programmed cell death 1-ligand 1 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 non-decalcified paraffin-embedded tissue specimens fixed in 10% neutral buffered formalin at Mayo Clinic in Rochester, Minnesota. Specimens are recommended to be placed in formalin within 1 hour of acquisition and fixed between 3 and 72 hours. This assay has not been validated on tissue or cellblocks subjected to alternative fixatives or decalcification.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 85147-7
- 59465-5
- 19139-5
- 81178-6
- 62364-5
- 80398-1
Result Turnaround Time
5-7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Formalin-fixed, paraffin-embedded tissue block OR 3 Unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue
Collection Instructions
This assay requires at least 100 viable tumor cells. Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer. One slide will be stained with hematoxylin and eosin and returned.
Storage Instructions
Ambient (preferred)
Causes for Rejection
Decalcified paraffin embedded tissue, Wet/frozen tissue, Cytology smears, Nonformalin fixed tissue including alcohol-formalin-acetic acid (AFA), 95% ethanol, PREFER fixatives or zinc formalin, Nonparaffin embedded tissue, Noncharged slides, ProbeOn slides, Snowcoat slides