Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
- Trade Name
- VENTANA PD-L1 (SP263) ASSAY
- PMA Number
- P160046
- Device Class
- FDA Class 3
- Product Code
- PLS
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 1, 2017
- Date Received
- October 20, 2016
- Expedited Review
- N
- Docket Number
- 17M-2768
Advisory Committee Statement
Approval for the VENTANA PD-L1 (SP263) Assay 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 status is determined by the percentage of tumor cells with any membrane staining above background or by the percentage of tumor-associated immune cells with staining (IC+) at any intensity above background. The percent of tumor area occupied by any tumor-associated immune cells (Immune Cells Present, ICP) is used to determine IC+, which is the percent area of ICP exhibiting PD-L1 positive immune cell staining. PD-L1 status is considered High if any of the following are met:1) >= 25% of tumor cells exhibit membrane staining; or,2) ICP > 1% and IC+ ? 25%; or,3) ICP = 1% and IC+ = 100%.PD-L1 High status as determined by VENTANA PD-L1 (SP263) Assay was associated with increased objective response rate (ORR) in a single arm study of IMFINZI (durvalumab).
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 |