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HelpTest Code SP263 Programmed Death-Ligand 1 (PD-L1) (SP263), Semi-Quantitative Immunohistochemistry, Manual
Ordering Guidance
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. For assistance with PD-L1 test selection as well as answers to frequently asked questions, see PD-L1 Immunohistochemistry Testing on MayoClinicLabs.com.
Shipping Instructions
Attach the green pathology address label included in the kit to the outside of the transport container.
Necessary Information
A pathology/diagnostic report and a brief history, including primary site of neoplasm, are required.
Specimen Required
Specimen Type: Tissue
Supplies: Pathology Packaging Kit (T554)
Collection Instructions: Formalin-fixed, paraffin-embedded tissue block; or 3 unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue
Additional Information: One slide will be stained with hematoxylin and eosin and returned.
Secondary ID
603755Useful For
Identification of neoplasms expressing programmed cell death 1-ligand 1 (clone SP263)
Method Name
Immunohistochemistry (IHC)
Reporting Name
PD-L1 (SP263) SemiQuant IHC, ManualSpecimen Type
SpecialSpecimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Special | Ambient (preferred) | ||
| Refrigerated | |||
Reject Due To
| Decalcified bone 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 |
Reject |
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 protein-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, thymus, colon, pancreas, ovary, breast, kidney, and in melanoma and glioblastoma.
Interpretation
The results of the test will be reported in form of scores. The scoring system is based on type and origin of tumor. If additional interpretation or analysis is needed, order PATHC / Pathology Consultation along with this test.
Cautions
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 nondecalcified paraffin-embedded tissue specimens fixed in 10% neutral-buffered formalin. Recommended fixation time is between 6 and 48 hours. 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.
Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.
Clinical Reference
1. Rimm DL, Han, G, Taube JM, et al. A prospective, multi-institutional, pathologist-based assessment of 4 immunohistochemistry assay for PD-L1 expression in non-small cell lung cancer. JAMA Oncol. 2017;3(8):1051-1058
2. Gaule P, Smithy JW, Toki M, et al. A quantitative comparison of antibodies to programmed cell death 1 Ligand 1. JAMA Oncol. 2017;3(2):256-259
3. Sunshine JC, Nguyen P, Kaunitz G, et al. PD-L1 expression in melanoma: A quantitative immunohistochemical antibody comparison. Clin Can Res. 2017;23(16):4938-4944
4. D'Incecco A, Andreozzi M, Ludovini V, et al. PD-1 and PD-L1 expression in molecularly selected non-small-cell lung cancer patients. Br J Cancer. 2015;112(1):95-102
5. Mansfield AS, Roden AC, Peikert T, et al. B7-H1 expression in malignant pleural mesothelioma is associated with sarcomatoid histology and poor prognosis. J Thorac Oncol. 2014;9(7):1036-1040
6. Magaki S, Hojat SA, Wei B, So A, Yong WH. An introduction to the performance of immunohistochemistry. Methods Mol Biol. 2019;1897:289-298. doi:10.1007/978-1-4939-8935-5_25
Method Description
Immunohistochemistry on sections of paraffin-embedded tissue using Ventana PD-L1 clone SP263.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
5 to 7 daysSpecimen Retention Time
Until reportedPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88360
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| SP263 | PD-L1 (SP263) SemiQuant IHC, Manual | In Process |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 603756 | Interpretation | 59465-5 |
| 603757 | Participated in the Interpretation | No LOINC Needed |
| 603758 | Report electronically signed by | 19139-5 |
| 603759 | Material Received | 81178-6 |
| 603760 | Disclaimer | 62364-5 |
| 603761 | Case Number | 80398-1 |
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763)
Oncology Test Request (T729)