Methodology
Immunohistochemistry (IHC)
Test Description

The VENTANA PD-L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) triple-negative breast carcinoma (TNBC) tissue on a VENTANA BenchMark ULTRA instrument. Evaluation is based on the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity. Primary or metastatic TNBC tissues may be submitted. Tissues with ≥1% IC are considered positive. For non-small cell lung cancer, please order PD-L1 SP142 FDA (TECENTRIQ®) for NSCLC.  For bladder cancer, please order PD-L1 SP142 FDA (TECENTRIQ®) for Urothelial Carcinoma.

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

Clinical Significance

PD-L1 expression in ≥1% tumor-infiltrating immune cells as determined by this assay in triple-negative breast carcinoma may be associated with increased progression-free survival in patients with advanced, locally unresectable or metastatic TNBC treated with TECENTRIQ® (atezolizumab) and chemotherapy. This test is a companion diagnostic for use of Tecentriq in certain TNBC cases.

Specimen Requirements
  • A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type
    or
  • One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 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

1. VENTANA PD-L1 (SP142) Assay [package insert]. Tucson, AZ: Ventana Medical Systems; 1017981US Rev B; 2019-03-08
2. TECENTRIQ® (atezolizumab) [package insert]. South San Francisco, CA: Genentech, Inc.; Revised 3/2019   
3. Schmid P. Adams S, Rugo HS, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med. 2018;379(22):2018-2121.

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.