PD-L1 22C3 pharmDx by Immunohistochemistry with Interpretation, pembrolizumab (KEYTRUDA)
2013284
Ordering Recommendation
Aid in prediction of response to pembrolizumab (KEYTRUDA), as first- or second-line therapy, for patients with non-small cell lung cancer (NSCLC).
Mnemonic
22C3 IP
Methodology
Immunohistochemistry
Performed
Mon-Fri
Reported
1-5 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
- Patient Preparation
- Collect
- Tumor tissue.
- Specimen Preparation
- Formalin fix (10 percent neutral buffered formalin) and paraffin embed 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 recommended but not required), available online through eSupply using ARUP Connect or contact ARUP Client Services at (800) 522-2787. (Min: 3 slides) If sending precut slides, do not oven bake.
- Storage/Transport Temperature
- Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
- Unacceptable Conditions
- Paraffin block with no tumor tissue remaining; specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens. Specimens with fewer then 100 viable tumor cells.
- Remarks
- 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.
- Stability
- Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Reference Interval
Interpretive Data
Refer to report.
Note
This test code includes pathologist interpretation. At least 100 viable tumor cells are required for interpretation.
CPT Code(s)
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 2012108 | PD-L1 Client Block ID | |
| 2013285 | PDL1 Tissue Source | |
| 2013286 | Adequacy of Specimen | |
| 2013287 | Tumor Proportion Score | |
| 2013288 | PDL1 22C3 by IHC Result |
Aliases
- Merck
- PD-L1
- PDL1
- Pembro