PD-L1 by IHC, 22C3, Keytruda®
Also known as: PD-L1 IHC 22C3 pharmDx
Use
The Dako PD-L1 22C3 pharmDx™ kit is intended for use in the detection of PD-L1 expression in formalin-fixed, paraffin-embedded tissue samples. The assay is aimed at assisting in the decision-making process for the use of Keytruda® (pembrolizumab), especially in cases such as non-small-cell lung cancer, cervical cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, and triple-negative breast cancer. The detection of PD-L1 may correlate with the efficacy of Keytruda® treatment in these cancers.
Special Instructions
The assay uses the Dako Autostainer Link 48 platform to analyze the expression of PD-L1 on tumor cells. It is crucial for the specimens to be sent within 6 months of sectioning to ensure sample quality. Please ensure sufficient tissue is available, and that the sample type is appropriate for the cancer indication being tested.
Limitations
The test may reject certain sample types including nasopharyngeal carcinoma and primary salivary gland carcinoma specimens. Cytology samples are accepted only for NSCLC but are rejected for other cancer indications. Insufficient tissue or inappropriate tissue source may lead to rejection of the sample.
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
2-3 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
At least three unstained slides sectioned at 4 to 5 microns. Five slides are ideal.
Minimum Volume
Not provided
Container
Paraffin block or unstained slides.
Collection Instructions
Send slides within 6 months of sectioning.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Insufficient tissue; inappropriate tissue source; incorrect specimen type; we cannot accept nasopharyngeal carcinoma and primary salivary gland carcinoma specimen. Cytology samples are accepted for NSCLC but rejected for all other indications (gastric, cervical, HNSCC, ESCC).