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  1. Recently-Approved Devices

cobas® EZH2 Mutation Test – P200014

Picture of an open box of the cobas® EZH2 Mutation Test

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: cobas® EZH2 Mutation Test
PMA Applicant: Roche Molecular Systems, Inc.
Address: 4300 Hacienda Drive, Pleasanton, CA 94588
Approval Date: June 18, 2020
Approval Letter: Approval Order

What is it? The cobas® EZH2 Mutation Test is a laboratory test designed to detect specific mutations in the EZH2 gene in tumor tissue taken from patients with follicular lymphoma. Identifying these mutations will help doctors identify patients with follicular lymphoma who should be considered for treatment with TAZVERIK™ (tazemetostat).

How does it work? The doctor takes a small amount of cancerous tissue from the patient and sends it to a laboratory. In the laboratory, DNA is isolated from a patient's tumor biopsy and mixed with chemical substances (reagents) to evaluate the presence or absence of the specific EZH2 mutations. A trained medical professional reviews the test results and sends the report to the ordering doctor. The presence of EZH2 gene indicates the patient may be considered for treatment with TAZVERIK™ (tazemetostat).

When is it used? Doctors use the cobas EZH2 Mutation Test to determine if a patient with follicular lymphoma may be considered for treatment with TAZVERIK™ (tazemetostat).

What will it accomplish? The cobas® EZH2 Mutation Test helps to identify the EZH2 mutation status and determine whether patients with follicular lymphoma should be considered for treatment with TAZVERIK (tazemetostat) which may extend their life.

When should it not be used? There are no known reasons not to use this test.

Additional information (including warnings, precautions, and adverse events):

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