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Test ID SP263 Programmed Death-Ligand 1 (PD-L1) (SP263), Semi-Quantitative Immunohistochemistry, Manual


Ordering Guidance


For information on selection of programmed cell death 1-ligand 1 (PD-L1) testing, see https://news.mayocliniclabs.com/pd-l1-by-immunohistochemistry/



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)

Specimen Type: 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.


Useful For

Identification of neoplasms expressing programmed cell death 1-ligand 1 (clone SP263)

Method Name

Immunohistochemistry (IHC)

Reporting Name

PD-L1 (SP263) SemiQuant IHC, Manual

Specimen Type

Special

Specimen Stability Information

Specimen Type Temperature Time Special Container
Special 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 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.

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 August 1;3(8):1051-1058 doi: 10.1001

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 April 20

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

Day(s) Performed

Monday through Friday

Report Available

5 to 7 days

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)

 

Mayo Clinic Laboratories | IHC Catalog Additional Information:

mcl-ihc-interp