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).
| Device | VENTANA PD-L1 (SP263) ASSAY |
| Classification Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | Ventana Medical Systems, Inc. |
| Date Received | 2016-10-20 |
| Decision Date | 2017-05-01 |
| Notice Date | 2017-05-02 |
| PMA | P160046 |
| Supplement | S |
| Product Code | PLS |
| Docket Number | 17M-2768 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ventana Medical Systems, Inc. 1910 E. Innovation Park Dr. tucson, AZ 85755 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160046 | | Original Filing |
| S015 |
2022-10-14 |
30-day Notice |
| S014 |
2022-07-12 |
30-day Notice |
| S013 | | |
| S012 |
2022-02-16 |
Special (immediate Track) |
| S011 |
2022-01-28 |
135 Review Track For 30-day Notice |
| S010 |
2021-06-14 |
Panel Track |
| S009 |
2021-02-22 |
Real-time Process |
| S008 |
2020-08-26 |
Real-time Process |
| S007 |
2020-01-13 |
Real-time Process |
| S006 |
2019-08-22 |
Real-time Process |
| S005 |
2018-06-18 |
Real-time Process |
| S004 |
2018-04-03 |
Normal 180 Day Track No User Fee |
| S003 | | |
| S002 | | |
| S001 |
2017-07-17 |
30-day Notice |
NIH GUDID Devices