PMA P150025S005

Device

PD-L1 IHC 28-8 pharmDx

Applicant

Agilent Technologies, Inc.

PMA number

P150025

Supplement

S005

Product code

PLS

Decision date

2017-05-03

Classification

Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

Generic name

Immunohistochemistry assay, antibody, programmed death-ligand 1

Approval order statement

Approval for the device which will be marketed under the trade name PD-L1 IHC 28 - 8 pharmDx and is indicated for a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) and melanoma tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab). Positive PD-L1 status as determined by PD-L1 IHC 28-8 pharmDx in melanoma is correlated with the magnitude of the treatment effect on progression-free survival from OPDIVO®.

Summary

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