VENTANA MMR RxDx Panel
FDA premarket approval P210001/S002 · decided 2022-06-16
Approval details
- PMA number
- P210001
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTANA MMR RxDx Panel
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- Date received
- 2021-12-20
- Decision date
- 2022-06-16
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for the VENTANA MMR RxDx Panel as a companion diagnostic for identifying MMR proficient (pMMR) patients with endometrial cancer for treatment with KEYTRUDA in combination with LENVIMA.
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