VENTANA MET (SP44) RxDx Assay
by Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) PMA
Active
PMA P240037
Overview
The VENTANA MET (SP44) RxDx Assay is a qualitative immunohistochemical assay classified as an Immunohistochemistry Assay, Antibody, MET. It employs rabbit monoclonal anti-MET, clone SP44, to detect MET protein expression in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) specimens via light microscopy. This assay is designed to evaluate tumor cell staining patterns, specifically membrane and/or cytoplasmic localization, to inform clinical decision-making.
This device is intended for in vitro diagnostic (IVD) use and operates on the BenchMark ULTRA or BenchMark ULTRA PLUS instruments in conjunction with the OptiView DAB IHC Detection Kit. It is single-use, requires interpretation by a qualified pathologist, and is regulated under FDA_PMA (PMA Number: P240037). The assay’s clinical cut-off is defined as ≥50% of tumor cells exhibiting strong staining (3+), aiding in identifying NSCLC patients potentially eligible for targeted therapy. Specimens must be FFPE, and results should be correlated with histological examination and clinical context.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP240037 | Date14 May 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Immunohistochemistry Assay, Antibody, MET
- PMA Number
- FDA Product Code
- SER
- 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 lung cancer specimens is this assay designed to evaluate, and why is the formalin-fixed, paraffin-embedded (FFPE) requirement important?
This assay is specifically designed for **non-squamous non-small cell lung cancer (NSCLC)** specimens. The requirement for FFPE specimens is critical because formalin fixation preserves tissue structure and protein integrity, ensuring reliable detection of MET protein expression via immunohistochemistry. Without FFPE processing, the assay’s ability to accurately identify membrane/cytoplasmic staining patterns—key for clinical decision-making—could be compromised.
How does the assay’s staining pattern and clinical cut-off help guide treatment decisions for NSCLC patients?
The assay evaluates **membrane and/or cytoplasmic staining** of MET protein in tumor cells, with a clinical cut-off of **≥50% of cells showing strong (3+) staining**. This threshold helps identify NSCLC patients who may benefit from targeted therapy with **EMRELIS™ (telisotuzumab vedotin-tllv)**, a drug approved for MET-amplified or MET-overexpressing tumors. The cut-off ensures only patients with sufficient MET expression are considered eligible, reducing unnecessary off-label use.
Is this assay compatible with any other instruments besides the BenchMark ULTRA or BenchMark ULTRA PLUS, and what detection kit must be used?
No, the VENTANA MET (SP44) RxDx Assay is **exclusively designed for use on the BenchMark ULTRA or BenchMark ULTRA PLUS instruments**. It requires the **OptiView DAB IHC Detection Kit** for staining, as specified in the assay’s intended use. Using alternative instruments or detection kits could alter staining consistency and compromise diagnostic accuracy.
Who should interpret the results of this assay, and what role does clinical correlation play in the decision-making process?
Results must be interpreted by a **qualified pathologist**, as the assay’s output—staining patterns and percentage of positive cells—requires expert evaluation to ensure accuracy. Clinical correlation is essential because the assay’s findings should be combined with **histological examination** and **relevant patient clinical information** (e.g., tumor grade, prior therapies) to inform treatment decisions. This multi-faceted approach minimizes false positives/negatives and tailors therapy to individual patient needs.
Is this assay reusable, and if not, what are the implications for workflow and cost management in a pathology lab?
The VENTANA MET (SP44) RxDx Assay is **single-use only**, meaning each test requires a new reagent application. This design ensures consistency and reduces cross-contamination risk but may impact workflow efficiency and budgeting in high-volume labs. Labs must account for per-test costs and plan for proper disposal of used reagents, balancing diagnostic needs with resource allocation.