cobas® EZH2 Mutation Test

FDA Premarket Approval P200014

Pre-market Approval Supplement Details

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.

Devicecobas® EZH2 Mutation Test
Generic NameSomatic Gene Mutation Detection System
ApplicantRoche Molecular System, Inc.
Date Received2020-03-02
Decision Date2020-06-18
PMAP200014
SupplementS
Product CodeOWD 
Advisory CommitteePathology
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular System, Inc. 4300 Hacienda Drive pleasanton, CA 94588

Supplemental Filings

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Supplement NumberDateSupplement Type
P200014Original Filing

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