Use for gastric/GEJ, urothelial, and cervical specimens only. Aid in prediction of response to pembrolizumab (KEYTRUDA) as second-line therapy for patients with gastric adenocarcinoma, gastroesophageal adenocarcinoma, urothelial carcinoma, or cervical cancer. For non-small cell lung cancer (NSCLC), see PD-L1 22C3 IHC for NSCLC with Tumor Proportion Score (TPS) Interpretation, pembrolizumab (KEYTRUDA) (2013284).
- 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
- 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. Lung specimens.
- 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: 5 months (Must be stored in the dark); Refrigerated: 5 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|
|3000223||Combined Positive Score||83053-9|
|3000224||PDL1 22C3 IHC Result||83052-1|