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cobas EZH2 Mutation Test

FDA PMA
PMA P200014

by Roche Molecular System, Inc.

Identity

Trade Name
cobas® EZH2 Mutation Test FDA PMA
Generic Name
Somatic gene mutation detection system FDA PMA

Identifiers

PMA Number
P200014 FDA PMA
FDA Product Code
OWD FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Pathology FDA PMA
FDA Decision
APPR Approved FDA PMA

The cobas EZH2 Mutation Test is a real-time allele-specific PCR system for qualitative detection of specific somatic mutations in the EZH2 gene. It identifies single nucleotide variations at positions Y646 (including Y646N, Y646F, Y646X, Y646H, Y646S, and Y646C), A682G, and A692V within DNA extracted from formalin-fixed paraffin-embedded (FFPE) human follicular lymphoma tumor specimens.

This in vitro diagnostic device is intended for laboratory use and operates as a single-use reagent kit. It requires FDA_PMA authorization (P200014) and is classified under device class 3. The test is designed to aid in identifying follicular lymphoma patients with EZH2 mutations for treatment consideration in accordance with approved therapeutic labeling, though it does not determine clinical efficacy or drug response.

Frequently asked questions

What is the purpose of the cobas EZH2 Mutation Test?

The cobas EZH2 Mutation Test is a real-time PCR system designed to detect specific somatic mutations in the EZH2 gene from FFPE human follicular lymphoma tumor specimens. It helps identify patients with these mutations for treatment consideration with TAZVERIK according to approved therapeutic labeling.

What mutations does the cobas EZH2 Mutation Test detect?

The test identifies single nucleotide variations at positions Y646 (including Y646N, Y646F, Y646X, Y646H, Y646S, and Y646C), A682G, and A692V within the EZH gene from FFPE human follicular lymphoma tumor specimens.

How is the cobas EZH2 Mutation Test supplied?

The test is supplied as a single-use reagent kit for laboratory use. It requires DNA extracted from formalin-fixed paraffin-embedded human follicular lymphoma tumor specimens to perform the qualitative detection of specific mutations.

What is the regulatory status of the cobas EZH2 Mutation Test?

The cobas EZH2 Mutation Test has FDA PMA authorization (P200014) and is classified under device class 3. It is intended for laboratory use and requires FDA authorization for its intended use in identifying follicular lymphoma patients with EZH2 mutations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: cobas® EZH2 Mutation Test - Roche Diagnostics USA, PDF cobas® EZH2 Mutation Test - Food and Drug Administration, Performance of the cobas EZH2 mutation test on clinical samples from ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Roche Molecular System, Inc.

Sources (1)

  • FDA PMA P200014 24 fields · synced Sep 18, 2026