PD‑L1 22C3 IHC with Tumor Proportion Score (TPS) Interpretation, pembrolizumab (KEYTRUDA) and cemiplimab‑rwlc (LIBTAYO)
Also known as: 22C3 IP
Use
PD‑L1 22C3 IHC with TPS interpretation is performed to assess tumor PD‑L1 expression for predicting response to pembrolizumab (KEYTRUDA) and cemiplimab‑rwlc (LIBTAYO) in advanced non‑small cell lung cancer (NSCLC). CPS interpretation is provided for other tumor types such as gastric, esophageal, GEJ adenocarcinoma, cervical carcinoma, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, and triple‑negative breast cancer, with off‑label TPS reporting for other tumor types.
Special Instructions
Tumor tissue must be FFPE, with block or ≥5 unstained positively charged slides (3‑5 µm thick; minimum 3 slides) submitted using ARUP tissue transport kit #47808. Include surgical pathology report and indicate tissue site. If multiple specimens are submitted, indicate a “Choose best block” order comment or place individual orders to avoid a Pathologist Block Selection Fee (test code 3002076).
Limitations
At least 100 viable tumor cells are required. Specimens fixed in anything other than 10% neutral buffered formalin, decalcified specimens, or blocks with no remaining tumor tissue are unacceptable. Slides that have been oven‑baked or specimens in non‑validated fixatives are not validated and should be interpreted with caution.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
3-7 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Not provided
Minimum Volume
5 slides (minimum 3 for block)
Container
Tissue block or unstained positively charged slides
Collection Instructions
Submit tumor tissue as formalin‑fixed, paraffin‑embedded block or ≥5 unstained (3‑ to 5‑micron) positively charged slides in ARUP tissue transport kit #47808; do not oven bake slides.
Storage Instructions
Room temperature preferred; refrigerated acceptable; ship in cooled container in summer.
Causes for Rejection
No tumor remaining in block; decalcified specimens; non‑10% neutral buffered formalin fixation; fewer than 100 viable tumor cells; oven‑baked slides.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Block: indefinite; Precut NSCLC slides: 6 months; gastric/GEJ: 5 months; ESCC: 1 month; cervical cancer: 1 month; HNSCC: 4 months; TNBC: 4 months |
| Refrigerated | Block: indefinite; Precut NSCLC slides: 6 months; gastric/GEJ: 5 months; ESCC: 4.5 months; cervical cancer: 5 months; HNSCC: 6 months; TNBC: 7.5 months |
| Frozen | Unacceptable |