Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
- Trade Name
- VENTANA PD-L1 (SP142) Assay
- PMA Number
- P160006
- Device Class
- FDA Class 3
- Product Code
- PLS
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision Code
- APCB
- Decision Date
- October 18, 2016
- Date Received
- February 22, 2016
- Expedited Review
- Y
- Docket Number
- 16M-3431
Advisory Committee Statement
Approval for the VENTANA PD-L1 (SP142) Assay. This device is indicated for the following: 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) urothelial carcinoma and non-small cell lung cancer (NSCLC) tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA instrument. Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity.PD-L1 expression in 5% IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue is associated with increased objective response rate (ORR) in a non-randomized study of TECENTRIQ (atezolizumab).PD-L1 expression in 50% TC or 10% IC as detected by VENTANA PD-L1 (SP142) Assay in NSCLC may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLS | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 | FDA class 3 | Unknown |