SHERIDAN, WYOMING – May 27, 2025 – Roche has announced FDA approval of its VENTANA® MET (SP44) RxDx Assay, marking a major milestone in companion diagnostics for non-small cell lung cancer (NSCLC). This approval paves the way for a more precise identification of patients eligible for AbbVie’s Emrelis™ (telisotuzumab vedotin-tllv), a targeted therapy for non-squamous NSCLC with MET protein overexpression.
Enhancing Treatment Precision in Lung Cancer Care
The VENTANA MET (SP44) RxDx Assay is the first FDA-approved companion diagnostic for detecting MET protein expression in NSQ-NSCLC patients. By identifying those with elevated levels of MET—a key predictive biomarker—the assay supports clinicians in selecting patients who are most likely to benefit from c-Met-targeted therapy.
“Understanding the molecular drivers in patients with non-small cell lung cancer is critical for therapy selection,” said Matt Sause, CEO of Roche Diagnostics. “By identifying MET protein expression at the appropriate stage in the patient journey, we can help provide timely, tailored treatment options that may improve patient outcomes and offer hope to those facing this challenging disease.”
Addressing the Leading Cause of Cancer-Related Deaths
Lung cancer remains the most fatal cancer worldwide, often detected only at advanced stages when treatment choices are limited and prognosis is poor. NSCLC accounts for approximately 85% of all lung cancer cases. Among patients with EGFR-wildtype NSQ-NSCLC, about 25% present high MET protein levels, making MET a vital factor in treatment planning.
The FDA’s accelerated approval of the assay is based on findings from the ongoing Phase 2 LUMINOSITY study, which investigates the efficacy and safety of Emrelis in patients with MET-overexpressing tumors. Notably, Emrelis demonstrated a 35% overall response rate and a median duration of response of 7.2 months in this subgroup.
Innovating with Companion Diagnostics for Personalized Care
The VENTANA MET (SP44) RxDx Assay stands out as the first immunohistochemistry (IHC) companion diagnostic for MET. It reflects Roche’s commitment to expanding its robust portfolio of IHC and in situ hybridisation (ISH) tests. These diagnostics are designed to provide crucial insights that inform clinical decision-making and enhance outcomes in personalized oncology.
Key features of the assay include:
- Detection of MET protein through IHC staining.
- Scoring by pathologists based on staining intensity and tumor cell percentage.
- MET overexpression defined as ≥50% tumor cells showing strong (3+) staining.
This innovation is more than a technological leap—it’s a strategic advance that aligns with Roche’s vision of precision medicine, providing actionable data that helps physicians personalize treatment plans for NSQ-NSCLC patients.
Roche’s Role as a Market Leader in Diagnostics
As the world’s largest biotech company and global leader in in-vitro diagnostics, Roche continues to leverage its legacy of scientific innovation to transform patient care. Founded in 1896, the company has remained at the forefront of personalized healthcare by integrating data, diagnostics, and pharmaceuticals to meet evolving clinical needs.
Sustainability and long-term impact are also cornerstones of Roche’s strategy. The company is committed to achieving net-zero emissions by 2045 and participates in major global initiatives, including the Science Based Targets initiative and the Sustainable Markets Initiative.
Looking Ahead
With the approval of the VENTANA MET (SP44) RxDx Assay, Roche not only sets a new benchmark in companion diagnostics but also strengthens the global oncology community’s capacity to offer individualized and effective treatments. This advancement underscores Roche’s leadership in precision oncology and its mission to improve lives through science.
Learn more at www.roche.com.