PD-L1 22C3 IHC with Combined Positive Score (CPS) Interpretation, pembrolizumab (KEYTRUDA)
Use for gastric/gastroesophageal junction (GEJ) adenocarcinomas, urothelial carcinoma, 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 only, to aid in prediction of response to pembrolizumab (KEYTRUDA). Refer to the PD-L1 Testing Algorithm for more information.
New York DOH Approval Status
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.
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 percent neutral buffered formalin. Decalcified specimens. Specimens with fewer than 100 viable tumor cells. Non-indicated tumor types, including non-small cell lung carcinomas.
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.
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
Refer to report.
This test code includes pathologist interpretation. At least 100 viable tumor cells are required for interpretation.
|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|