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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
Devicecobas® EZH2 Mutation Test
Generic NameSomatic gene mutation detection system
ApplicantRoche Molecular System, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588
PMA NumberP200014
Date Received03/02/2020
Decision Date06/18/2020
Product Code OWD 
Docket Number 20M-1600
Notice Date 06/22/2020
Advisory Committee Pathology
Clinical TrialsNCT01897571
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for The cobas® EZH2 Mutation Test. The device is a real-time allele-specific PCR test for qualitative detection of single nucleotide mutations for Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 gene in DNA extracted from formalin fixed paraffin embedded (FFPE) human follicular lymphoma tumor tissue specimens. The cobas® EZH2 Mutation Test is intended for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK (tazemetostat), in accordance with the approved therapeutic product labeling.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S003 S004 S007 S008 S005 S006 
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