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Test Code 22C3 Programmed Death-Ligand 1 (PD-L1) (22C3), 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

603762

Useful For

Identification of neoplasms expressing programmed cell death 1-ligand 1 (clone 22C3)

Method Name

Immunohistochemistry (IHC)

Reporting Name

PD-L1 (22C3) SemiQuant IHC, Manual

Specimen Type

Special

Specimen 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-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.

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 the 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. doi:10.1001/jamaoncol.2017.0013

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. doi:10.1001/jamaoncol.2016.3015

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. doi:10.1158/1078-0432.CCR-16-1821

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. doi:10.1038/bjc.2014.555

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. doi:10.1097/JTO.0000000000000177

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 Dako PD-L1 clone 22C3.(Unpublished Mayo method)

Day(s) Performed

Monday through Friday

Report Available

5 to 7 days

Specimen Retention Time

Until reported

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed using an analyte specific reagent. 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
22C3 PD-L1 (22C3) SemiQuant IHC, Manual 85147-7

 

Result ID Test Result Name Result LOINC Value
603763 Interpretation 59465-5
603764 Participated in the Interpretation No LOINC Needed
603765 Report electronically signed by 19139-5
603766 Material Received 81178-6
603767 Disclaimer 62364-5
603768 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)