Ventana MMR RxDx Panel Solid Tumors with dMMR Status
by Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) PMA
Active
PMA P210001
Overview
The Ventana MMR RxDx Panel is an Immunohistochemistry test, DNA mismatch repair (MMR) protein assay, designed to identify solid tumors with deficient mismatch repair (dMMR) status. This companion diagnostic (CDx) supports clinical decision-making by detecting protein expression levels of MLH1, MSH2, MSH6, and PMS2 via automated immunohistochemistry, enabling targeted treatment selection for eligible patients.
This assay is intended for use in clinical pathology laboratories and is supplied as a reagent kit for automated staining systems. It is not single-use or sterile but requires proper handling per manufacturer instructions, with results interpreted by trained pathologists. The device holds FDA PMA approval (P210001) and is classified under FDA regulation 864.1860 as a Class III device, adhering to strict validation and compliance standards for companion diagnostics.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP210001 | Date17 Aug 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- VENTANA MMR RxDx Panel
- Generic Name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- PMA Number
- FDA Product Code
- QNH
- Device Class
- Class III
- Regulation
- 21 CFR Part 864.1860
- Advisory Committee
- Pathology
- FDA Decision
- APPR Approved
Other devices from Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Questions
What types of solid tumors can the Ventana MMR RxDx Panel help identify as deficient in mismatch repair (dMMR)?
The Ventana MMR RxDx Panel is designed to detect dMMR status in **solid tumors** by assessing protein expression levels of **MLH1, MSH2, MSH6, and PMS2** through automated immunohistochemistry. It supports clinical decision-making for patients who may benefit from targeted treatments based on their dMMR status, though the specific tumor types are not explicitly listed—it is intended for general use in solid tumors where dMMR testing is clinically relevant.
Is the Ventana MMR RxDx Panel meant for use in any specific clinical setting, and how is it supplied?
This panel is **intended exclusively for use in clinical pathology laboratories** and is supplied as a **reagent kit** for automated staining systems. It is not a point-of-care or bedside device, and its use requires trained pathologists to interpret results. The kit is not single-use or sterile, so proper handling and storage per manufacturer instructions are mandatory.
How does the Ventana MMR RxDx Panel differ from other MMR testing methods, and what regulatory pathway does it follow?
Unlike molecular-based MMR testing (e.g., PCR or NGS), the Ventana MMR RxDx Panel uses **automated immunohistochemistry (IHC)** to detect protein expression of MLH1, MSH2, MSH6, and PMS2. It holds **FDA PMA approval (P210001)** as a **Class III companion diagnostic (CDx)**, meaning it is specifically authorized to help select patients for treatment with **JEMPERLI** based on dMMR status. This pathway ensures rigorous validation for its clinical utility.
Can this panel be reused, and what storage or handling precautions should be taken?
The Ventana MMR RxDx Panel is **not single-use**, but it is **not sterile** and must be handled according to the manufacturer’s instructions to maintain integrity. Since it is a reagent kit for automated systems, proper storage (e.g., refrigeration if required) and expiration checks are critical. Reuse is permitted only within the constraints of the kit’s design and the laboratory’s standard operating procedures.