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FDA-approved companion diagnostic

Ventana MET (SP44) RxDx Assay

Qualitative IHC assay using rabbit monoclonal anti-MET (clone SP44) to detect MET protein expression in FFPE tumor tissue and support MET-targeted treatment decisions.

IVD-developed CDxMethod: IHCSpecimen: Tissue (FFPE)Biomarker: MET protein expression
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Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P240037
Supplements
Manufacturer
Ventana Medical Systems, Inc. (Roche Diagnostics)
Approval date
May 14, 2025
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
MET protein expression
What this test is

VENTANA MET (SP44) RxDx Assay is an FDA-approved, qualitative immunohistochemistry test that uses a rabbit monoclonal anti-MET antibody, clone SP44, to detect MET protein expression in formalin-fixed, paraffin-embedded tumor tissue on VENTANA BenchMark instruments. It classifies samples as MET positive or negative by predefined scoring criteria to help identify patients who may be candidates for MET-directed treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Non-Small Cell Lung Cancer (NSCLC)METMET protein expression (>= 50% of tumor cells exhibiting strong membrane and/or cytoplasmic staining 3+)EMRELIS

IVD Manufacturer

Ventana Medical Systems, Inc. (Roche Diagnostics)

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Order this test

If your organization is connected to Casandra, you can place an electronic order forVentana MET (SP44) RxDx Assay directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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