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PD-L1, IHC with Interpretation
Test Code94007
CPT Codes
88360
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block submitted in an IHC Specimen Transport Kit
Other Acceptable Specimens
Minimum 5 unstained, positively charged slides
Instructions
This test is intended mainly for solid tumors other than lung cancer or melanoma specimens; however cell blocks with primary or metastatic lung cancer are acceptable for this assay.
If not FFPE: State any other type of fixative used.
A pathology report which includes the paraffin block number, and both macroscopic and microscopic evaluation and diagnosis, should be sent with the specimens.
If not FFPE: State any other type of fixative used.
A pathology report which includes the paraffin block number, and both macroscopic and microscopic evaluation and diagnosis, should be sent with the specimens.
Transport Temperature
Tissue block: Room temperature
Slides: Refrigerated (cold packs)
Slides: Refrigerated (cold packs)
Specimen Stability
Tissue block
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Slides
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Slides
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Previously stained slides • Cytospins • Monolayer preparation/slides
Methodology
Immunohistochemical Stain
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon-Fri; Report available: 2-4 days
Reference Range
See Laboratory Report
Clinical Significance
This PD-L1 qualitative assay is intended for use in the detection of PD-L1 expression in cancers. Immunotherapies targeting the PD-1/PD-L1 pathway have been reported to have durable anti-tumor effects in a subset of patients with solid tumors.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153