Programmed Death-Ligand 1 (PD-L1) (SP142), Semi-Quantitative Immunohistochemistry, Manual
Use
The test is useful for the identification of neoplasms expressing programmed cell death 1-ligand 1 (PD-L1), a transmembrane protein that plays a role in immune response regulation. Overexpression of PD-L1 has been identified as a prognostic and theranostic marker across various neoplasms including carcinomas of the urinary bladder, lung, thymus, colon, pancreas, ovary, breast, kidney, as well as melanoma and glioblastoma. This biomarker is significant in predicting the response to PD-L1 inhibitors used in cancer therapies, particularly in patients with specific tumor types and treatment histories.
Special Instructions
The test requires a pathology report and a brief history, including the primary site of neoplasm. Specimens must be formalin-fixed, paraffin-embedded tissue or unstained glass slides with the appropriate specifications. It is crucial to attach the green 'Attention Pathology' label to the transport container. A specific scoring method based on tumor type is used, and the test should not be the sole factor in treatment decision due to other existing predictive markers like tumor mutation burden and microsatellite instability.
Limitations
This test has not been FDA-approved but is modified according to CLIA standards. It is validated for non-decalcified paraffin-embedded tissue specimens fixed in 10% neutral buffered formalin. Issues in specimen handling, such as time to formalin fixation and unsuitable glass slides, may affect test results. The assay stability may be affected by the age of cut paraffin sections and the environmental conditions affecting charged slides.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 85149-3
- 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 unstained glass slides
Storage Instructions
Ambient (preferred) or Refrigerated
Causes for Rejection
Decalcified paraffin embedded tissue, wet/frozen tissue, cytology smears, nonformalin fixed tissue, nonparaffin embedded tissue, noncharged slides, ProbeOn slides, Snowcoat slides