PD-L1 by IHC, Opdivo®
Also known as: PD-L1 IHC 28-8 pharmDx
Use
The PD-L1 by IHC test, using the Dako PD-L1 28-8 pharmDx™ kit, is intended for the detection of PD-L1 expression in formalin-fixed, paraffin-embedded tissue samples. This can assist in the assessment of eligibility for Opdivo® (nivolumab) treatment in patients with specific cancer types, including non-small-cell lung cancer (NSCLC), urothelial carcinoma (bladder cancer), and head and neck squamous cell carcinoma (HNSCC). The test is utilized as a qualitative assay in oncology to determine the presence of the PD-L1 protein, which can indicate the likelihood of a positive response to immunotherapy with Opdivo®.
Special Instructions
Not provided.
Limitations
The test can produce false-negative results if the tissue sample is fixed with chemicals other than 10% neutral buffered formalin or if the fixation duration exceeds 72 hours. The test is also limited to specific cancer types and is not validated for tumor types other than non-small-cell lung cancer (NSCLC), bladder cancer, and head and neck squamous cell carcinoma (HNSCC). Sufficient tissue sample size and quality are critical for accurate results; insufficient tissue or incompatible tumor types may result in test rejection.
Methodology
Immunoassay (IHC)
Biomarkers
PD-L1
Protein
LOINC Codes
- 83056-2 - PD-L1 by 28-8 Tiss ImStn-Imp
Result Turnaround Time
2-4 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
One FFPE tissue block or five unstained slides
Minimum Volume
Not provided
Container
Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides
Collection Instructions
Tissue should be fixed in 10% neutral buffered formalin for no more than 72 hours, then embedded in paraffin.
Storage Instructions
Room temperature
Causes for Rejection
Insufficient tissue; tumor other than non-squamous non-small-cell lung cancer
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