PD-L1, IHC with Interpretation

Test Code

94007

CPT Codes
88360

Preferred Specimen

Formalin-fixed, paraffin-embedded tissue in IHC specimen transport kit

Other Acceptable Specimens

5 unstained charged(+) slides collected in IHC specimen transport kit

Instructions

This test is intended mainly for solid tumors other than lung cancer, melanoma specimens or urothelial carcinoma; 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.

Transport Temperature

Room temperature

Specimen Stability

Formalin-fixed, paraffin embedded tissue
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 U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Sets up 5 days a week.

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.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.