Alternative Name
PD-L1, SP263 FDA (IMFINZI™)
Methodology
Immunohistochemistry (IHC)
Test Description

The VENTANA PD-L1 (SP263) assay is an FDA-approved complementary diagnostic IHC test for PD-L1 status in patients with locally advanced or metastatic urothelial carcinoma (mUC) who are being considered for treatment with  IMFINZI™ (durvalumab). This is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP263 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue stained with OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. PD-L1 high expression status as determined by this assay was associated with increased objective response rate (ORR) in a single arm study of durvalumab.

Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer’s online interpretation training.

Specimen Requirements
  • A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type
    or
  • One (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered
  • Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Storage and Transportation

Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

CPT Code(s)*
88360x1
Turnaround Time

Global: 48 hours, Tech-Only (stain only): 24 hours

References

PD-L1 SP263 Assay [package insert]. Tucson, AZ: Ventana Medical Systems, Inc.; 1014737US Rev A; 2017-04-21

Level of Service
Global
Stain Only

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.