PD-L1 IHC, NSCLC Keytruda®

CPT: 88360
Updated on 03/28/2024
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  • Pembrolizumab; Programmed Death Ligand 1

Special Instructions

PD-L1 testing will be delayed if the pathology report is not received.

Note: This test number is used for tracking oncology IHC specimens to the laboratory. Bill codes will be added when testing is complete based on the processes performed in the laboratory.

Expected Turnaround Time

4 - 5 days

6 - 10 days

4 - 5 days

Specimen Requirements


Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides


One tissue block or five unstained, positively charged slides less than one month old

Minimum Volume

Three unstained, positively charged slides


Paraffin block or unstained, positive-charged slides


Tissue should be fixed in 10% neutral-buffered formalin for no more than 72 hours. Embed in paraffin. Slides should be no more than one month old.

Storage Instructions

Refrigerate; protect from light.

Causes for Rejection

Insufficient tumor; tumor other than non-small-cell lung cancer; slides sectioned more than one month prior to test request

Test Details


The Dako PD-L1 22C3 pharmDx™ kit is a qualitative assay intended for use in the detection of PD-L1 in formalin-fixed, paraffin-embedded (FFPE) in non-small cell lung carcinoma (NSCLC) using the Dako Automated Link 48 platform.


Immunohistochemistry (IHC) using Dako Automated Link 48 platform


Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non−small-cell lung cancer. N Engl J Med. 2015 May 21;372(21):2018-2028.25891174
Herbst RS, Baas P, Kim D-W, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomized controlled trial. Lancet. 2016 Apr 9;387(10027):1540-1550. Epub 2015 Dec 19.26712084
Libtayo® [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; 2021.
Mok TSK, Wu Y-L, Kudaba I, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1 expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomized, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. Epub 2019 Apr 4.30955977
PD-L1 IHC 22C3 pharmDx™ [package insert]. P02893 rev04 IUO IFU. Carpinteria, Calif: Dako; 2014:1-6.


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
452359 PD-L1 IHC, NSCLC Keytruda (R) 452360 Result 55229-9
452359 PD-L1 IHC, NSCLC Keytruda (R) 452361 % Tumor Cells Staining: % 83053-9
452359 PD-L1 IHC, NSCLC Keytruda (R) 452362 Comments: 77202-0
452359 PD-L1 IHC, NSCLC Keytruda (R) 452363 Interpretation 50595-8
452359 PD-L1 IHC, NSCLC Keytruda (R) 452364 Director Review 72486-4

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