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PD-L1 22C3 by Immunohistochemistry, with Interpretation
Ordering Recommendation
PD-L1 22C3 is used as a companion diagnostic test for KEYTRUDA or LIBTAYO based on primary tumor type. The type of scoring will be determined by an ARUP medical director based on the provided pathology report.
Combined positive score (CPS) interpretation will be provided for gastric, esophageal, gastroesophageal junction (GEJ) adenocarcinoma, cervical carcinomas (squamous cell carcinomas and adenocarcinomas), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), and triple-negative breast cancer (TNBC) specimens to aid in prediction of response to pembrolizumab (KEYTRUDA).
Tumor proportion score (TPS) interpretation will be provided for non-small cell lung cancer (NSCLC) specimens to aid in the prediction of response to pembrolizumab (KEYTRUDA) and cemiplimab (LIBTAYO) for patients with advanced NSCLC.
Other tumor types will be reported with TPS and an off-label disclaimer.
Refer to the Additional Technical Information document for more information.
New York DOH Approval Status
Specimen Required
Tumor tissue
Formalin fixed (10% neutral buffered formalin) and paraffin embedded (FFPE) specimen. Protect paraffin block and/or slides from excessive heat. Transport tissue block or 5 unstained (3- to 5-micron thick sections), positively charged slides in a tissue transport kit (ARUP supply #47808 required), available online through eSupply using ARUP Connect(TM) or contact ARUP Client Services at 800-522-2787. (Min: 3 slides) If sending precut slides, do not oven bake.
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Paraffin block with no tumor tissue remaining; specimens fixed in any fixative other than 10% neutral buffered formalin. Decalcified specimens. Specimens with fewer than 100 viable tumor cells.
Include surgical pathology report and indicate tissue site with the test order. For additional technical details, please contact ARUP Client Services at 800-522-2787. If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.
Paraffin block: Ambient indefinitely, Refrigerated indefinitely, Frozen: Unacceptable
Precut NSCLC slides: Ambient 6 months, Refrigerated 6 months, Frozen: Unacceptable
Precut gastric/GEJ adenocarcinoma slides: Ambient: 5 months, Refrigerated 5 months, Frozen: Unacceptable
Precut ESCC slides: Ambient 1 month, Refrigerated 4.5 months, Frozen: Unacceptable
Precut cervical cancer slides: Ambient 1 month, Refrigerated 5 months, Frozen: Unacceptable
Precut HNSCC slides: Ambient 4 months, Refrigerated 6 months, Frozen: Unacceptable
Precut TNBC slides: Ambient 4 months, Refrigerated 7.5 months, Frozen: Unacceptable
Methodology
Immunohistochemistry (IHC)
Performed
Mon-Fri
Reported
3-7 days
Reference Interval
Interpretive Data
Refer to report.
FDA
Note
This test code includes pathologist interpretation. At least 100 viable tumor cells are required for interpretation. Submission of slides that have been oven baked, or specimens that are decalcified and/or fixed in any fixative other than 10% neutral buffered formalin are not validated and should be interpreted with caution.
Hotline History
Hotline History
CPT Codes
88360
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 2012108 | PD-L1 Client Block ID | 94736-6 |
| 2013285 | PDL1 Tissue Source | 31208-2 |
| 2013286 | Adequacy of Specimen | |
| 3017616 | PDL1 TEST | 83052-1 |
Aliases
- 22C3
- Libtayo
- Merck
- PD-L1
- PDL1
- Pembro
- Regeneron
