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Device | VENTANA PD-L1(SP142) CDX ASSAY |
Classification Name | immunohistochemistry assay, antibody, programmed death-ligand 1 |
Generic Name | immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant |
VENTANA MEDICAL SYSTEMS, INC. |
1910 east innovation park dr. |
tucson, AZ 85755 |
|
PMA Number | P160002 |
Supplement Number | S006 |
Date Received | 06/14/2018 |
Decision Date | 07/02/2018 |
Product Code | |
Advisory Committee |
Pathology |
Clinical Trials |
NCT02807636
|
Supplement Type | normal 180 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval for modifying the intended use of the VENTANA PD-L1(SP142). The 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 indicated as an aid in identifying urothelial carcinoma patients for treatment with TECENTRIQ (atezolizumab).PD-L1 expression in >= 50% TC or >= 10% IC determined by VENTANA PD-L1 (SP142) Assay in NSCLC tissue may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).See the TECENTRIQ® product label for PD-L1 expression cutoff values guiding therapy in specific clinical circumstances.This product is intended for in vitro diagnostic (IVD) use. |