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PD-L1 22C3 IHC for NSCLC by Immunohistochemistry with Interpretation, pembrolizumab (KEYTRUDA)
2013284
Ordering Recommendation

Use for non-small cell lung cancer (NSCLC) specimens only. Companion diagnostic testing to aid in the prediction of response to pembrolizumab (KEYTRUDA) as first- or second-line monotherapy for patients with NSCLC. For gastric/GEJ, urothelial, and cervical specimens, see PD-L1 22C3 IHC with Combined Positive Score (CPS) Interpretation, pembrolizumab (KEYTRUDA) (3000197).

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 Connector 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
Gastric/GEJ specimens. Paraffin block with no tumor tissue remaining. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens. Specimens with fewer than 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
Slides: Ambient: 6 months (Must be stored in the dark); Refrigerated: 6 months (Must be stored in the dark); Frozen: Unacceptable
Paraffin Block: 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.
Hotline History
View Hotline History
Components
Component Test Code*Component Chart NameLOINC
2012108PD-L1 Client Block ID57723-9
2013285PDL1 Tissue Source31208-2
2013286Adequacy of Specimen
2013287Tumor Proportion Score
2013288PDL1 22C3 by IHC Result
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Merck
  • PD-L1
  • PDL1
  • Pembro