PD-L1 22C3 IHC with Tumor Proportion Score (TPS) Interpretation, pembrolizumab (KEYTRUDA) and cemiplimab-rwcl (LIBTAYO)
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 or to cemiplimab-rwlc (LIBTAYO) as first-line treatment of patients with advanced NSCLC whose tumors have a TPS of ≥50 percent. For gastric/GEJ adenocarcinoma, esophageal squamous cell carcinoma, urothelial carcinoma, cervical carcinoma, head and neck squamous cell carcinoma (HNSCC), or triple-negative breast cancer (TNBC) 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.
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.
Tumor types that have FDA approval for PD-L1 22C3 testing with combined positive score (CPS). 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.
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: 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
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|
|2013287||Tumor Proportion Score|
|2013288||PDL1 22C3 by IHC Result|