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Turnaround Time
2 - 4 days
Use
The Dako PD-L1 22C3 pharmDx™ kit is a qualitative assay intended for use in the detection of PD-L1 in formalin-fixed, paraffin-embedded (FFPE) in epithelial ovarian, fallopian tube or primary peritoneal cancer tissues using the Dako Automated Link 48 platform.
Special Instructions
PD-L1 testing will be delayed if the pathology report is not received.
Note: This test number is used for tracking oncology IHC specimens to the laboratory. Bill codes will be added when testing is complete, based on the processes performed in the laboratory.
Methodology
Immunohistochemistry (IHC) using Dako Automated Link 48 platform
Related Documents
References
Colombo N, et al. Pembrolizumab vs placebo plus weekly paclitaxel with or without bevacizumab for platinum-resistant recurrent ovarian cancer: results from the randomized, double-blind phase 3 ENGOT-ov65/KEYNOTE-B96 study. Presented at ESMO Congress 2025, Berlin, Germany; Oct 18, 2025.
Merck & Co. Inc. Keytruda (pembrolizumab) [prescribing information]. Whitehouse Station, NJ: Merck & Co. Inc.; Feb 2026.
PD-L1 IHC 22C3 PharmDx [package insert]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2026.
Specimen Requirements
Information on collection, storage, and volume
Specimen
Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides
Volume
One tissue block or four unstained, positively charged slides less than one month old
Minimum Volume
Three unstained, positively charged slides
Container
Paraffin block or unstained, positive-charged slides
Storage Instructions
Refrigerate; protect from light.
Causes for Rejection
Insufficient tumor; slides sectioned more than one month prior to test request
Collection
Tissue should be fixed in 10% neutral-buffered formalin for no more than 72 hours. Embed in paraffin. Slides should be no more than one month old.
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