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 adenocarcinoma, urothelial carcinoma, cervical carcinoma, or head and neck squamous cell carcinoma (HNSCC) specimens, see PD-L1 22C3 IHC with Combined Positive Score (CPS) Interpretation, pembrolizumab (KEYTRUDA) (3000197). Refer to the PD-L1 Testing Algorithm for more information.
- Patient Preparation
- 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.
- 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.
- 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
|Component Test Code*||Component Chart Name||LOINC|
|2012108||PD-L1 Client Block ID||57723-9|
|2013285||PDL1 Tissue Source||31208-2|
|2013286||Adequacy of Specimen|
|2013287||Tumor Proportion Score|
|2013288||PDL1 22C3 by IHC Result|