| |
| Device | VENTANA PD-L1 (SP142) Assay |
|---|
| Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
|---|
| Applicant | VENTANA MEDICAL SYSTEMS, INC.
1910 EAST INNOVATION PARK DR.
TUCSON, AZ 85755 |
|---|
| PMA Number | P160006 |
|---|
| Date Received | 02/22/2016 |
|---|
| Decision Date | 10/18/2016 |
|---|
|
APCB Date
|
11/14/2016 |
|---|
| Product Code |
PLS |
| Docket Number | 16M-3431 |
|---|
| Notice Date | 11/15/2016 |
|---|
| Advisory Committee |
Pathology |
|---|
| Clinical Trials | NCT02031458
|
|---|
| Expedited Review Granted? | Yes |
|---|
| Combination Product | No |
|---|
Approval Order 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). |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
|
|
|
