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).
| Device | VENTANA PD-L1 (SP142) Assay |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. |
| Date Received | 2016-02-22 |
| Decision Date | 2016-10-18 |
| Notice Date | 2016-11-15 |
| PMA | P160006 |
| Supplement | S |
| Product Code | PLS |
| Docket Number | 16M-3431 |
| Advisory Committee | Pathology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160006 | Original Filing |