Find Locations
For hours, walk-ins and appointments.Synonyms
- 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
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
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4 - 5 days |
Specimen Requirements
Specimen
Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides
Volume
One tissue block or five unstained, positively charged slides less than one month old
Minimum Volume
Three unstained, positively charged slides
Container
Paraffin block or unstained, positive-charged slides
Collection
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
Use
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.
Methodology
Immunohistochemistry (IHC) using Dako Automated Link 48 platform
References
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.
LOINC® Map
| 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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