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VENTANA® MET (SP44) RxDx Assay
US-FDA
IVD
For in vitro diagnostic use.
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First IHC companion diagnostic for determining MET protein expression in patients with non-squamous, non-small cell lung cancer eligible for treatment with EmrelisTM (telisotuzumab vedotin-tllv)1
The VENTANA MET (SP44) RxDx Assay is the first FDA-approved immunohistochemistry (IHC) assay to identify patients with non-squamous, non-small cell lung cancer (NSQ-NSCLC) who are eligible for MET-targeted treatment with EmrelisTM (telisotuzumab vedotin-tllv).1
Lung cancer is one of the most frequently diagnosed cancers and is the leading cause of cancer-related death worldwide in both men and women.2 NSCLC represents approximately 80-85% of all new lung cancer cases. Patients diagnosed with advanced NSCLC often face a poor prognosis, with median survival of less than one year.1,2
MET serves as a predictive biomarker for the likelihood of response to MET-targeted therapy for patients with non-small cell lung cancer.1
MET (also called tyrosine-protein kinase MET or c-MET) is a heterodimeric receptor tyrosine kinase encoded by the MET proto-oncogene located on chromosome 7q21-q31 and is expressed on the surface of various epithelial cells.3
This makes the MET protein an actionable target for antibody drug conjugates (ADCs).4,5
MET protein overexpression is found in approximately 25% of advanced EGFR wild type NSCLC patients and is often associated with poor prognosis.5
VENTANA MET (SP44) RxDx Assay staining in NSQ-NSCLC exhibits a membranous and/or cytoplasmic pattern. The staining signal intensity is classified as strong, moderate, weak, or negative based on membranous and/or cytoplasmic localization.1
In NSQ-NSCLC, tumor cells stained with VENTANA MET (SP44) RxDx Assay are evaluated for percentage of tumor cells exhibiting strong (3+) intensity. Strong staining intensity is characterized by dark brown to black staining of the membranes and/or cytoplasm. Strong staining membranes and/or cytoplasm are easily detectable at low power magnifications such as 2x or 4x.1
References
- VENTANA MET (SP44) RxDx Assay, US FDA Package Insert (1018335US Rev A), 2025.
- Camidge DR, et al. Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein-Overexpressing Advanced Nonsquamous EGFR-Wildtype Non-Small Cell Lung Cancer in the Phase II LUMINOSITY Trial. J Clin Oncol. 2024 Sep 1;42(25):3000-3011. Doi: 10.1200/JCO.24.00720.
- American Society of Clinical Oncology. What is Lung Cancer?. https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed Jan 21, 2025.
- Trusolino, L, Bertotti, A, & Comoglio, PM (2010). MET signalling: Principles and functions in development, organ regeneration and cancer. Nature Reviews Molecular Cell Biology, 11(12), 834-848. doi:10.1038/nrm3012
- Wang J, Anderson MG, Oleksijew A, et al. ABBV-399, a c-Met Antibody–Drug Conjugate that Targets Both MET–Amplified and c-Met–Overexpressing Tumors, Irrespective of MET Pathway Dependence. Clin Cancer Res 15 February 2017; 23 (4): 992–1000. https://doi.org/10.1158/1078-0432.CCR-16-1568
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