PD‑L1 28‑8 FDA for NSCLC
Also known as: Formerly named PD-L1 28-8 FDA (OPDIVO® + YERVOY®) for NSCLC
Use
PD‑L1 IHC 28‑8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti‑PD‑L1, clone 28‑8, intended for detection of PD‑L1 protein in FFPE non‑small cell lung cancer tissue. It serves as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) or OPDIVO in combination with YERVOY® (ipilimumab). Results are positive when PD‑L1 is expressed in ≥1% of tumor cells, supporting treatment decisions. Stain‑only (tech‑only) testing is available for clients with completed interpretation training.
Special Instructions
Stain‑only (tech‑only) testing is available to clients who have completed the test kit manufacturer’s online interpretation training.
Limitations
Not provided.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Formalin‑fixed, paraffin‑embedded (FFPE) tissue block preferred; or one unbaked, unstained H&E slide and two to three positively charged unstained slides cut at 4‑5 microns. Tissue must contain at least 100 viable tumor cells.
Storage Instructions
Use cold pack for transport, not in direct contact with specimen; NYS clients provide date and time of Collection.
Causes for Rejection
Less than 100 viable tumor cells