PD-L1 22C3 IHC with Tumor Proportion Score (TPS) Interpretation, pembrolizumab (KEYTRUDA)
Test Mnemonic
PDL1KE
CPT Codes
- 88360 - QTY (1)
Includes
- PD-L1 Client Block ID
- PDL1 Tissue Source
- Adequacy of Specimen
- Tumor Proportion Score
- PDL1 22C3 by IHC Result
Performing Laboratory
ARUP
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| N/A | Tissue, tumor | Formalin-fixed, paraffin-embedded block | Ambient | Formalin fix (10% 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). Include surgical pathology report and indicate tissue site. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| Three | Slides |
Stability
| Environmental Condition | Description |
|---|---|
| Ambient | Slides: 6 months, must be stored in the dark; Paraffin block: Indefinitely |
| Refrigerated | Slides: 6 months, must be stored in the dark; Paraffin block: Indefinitely |
| Frozen | Slides: Unacceptable; Paraffin block: Unacceptable |
Days Performed
Mon - Fri
Turnaround Time
2 - 6 days
Methodology
| Name | Description |
|---|---|
| Immunohistochemistry |
Reference Range
Special Info
This test code includes pathologist interpretation. At least 100 viable tumor cells are required for interpretation. Include surgical pathology report and indicate tissue site with the test order. If sending precut slides, do not oven bake. Gastric/GEJ specimens are unacceptable. Paraffin block with no tumor tissue remaining will be rejected. Specimens fixed in any fixative other than 10% neutral buffered formalin, decalcified specimens, and specimens with fewer than 100 viable tumor cells are unacceptable. This test is New York DOH approved.
Clinical Info
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.