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.
| Device | cobas® EZH2 Mutation Test |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Roche Molecular System, Inc. |
| Date Received | 2020-03-02 |
| Decision Date | 2020-06-18 |
| PMA | P200014 |
| Supplement | S |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular System, Inc. 4300 Hacienda Drive pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200014 | Original Filing | |
| S004 | 2022-10-18 | 30-day Notice |
| S003 | 2021-02-22 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 | 2020-07-27 | 30-day Notice |