FDA Approves Roch's NSCLC Diagnostic Linked to Emrelis

Roche has announced FDA approval for the Ventana MET (SP44) RxDx Assay, emphasizing their first companion diagnostic designed to identify MET protein appearance in patients with “non-squamous non-small cell lung cancer” (NSQ-NSCLC). This test now allows the identification of patients entitled for treatment with Emrelis (telisotuzumab vedotin-tllv), AbbVie’s MET-targeted therapy.

Matt Sause, CEO of Roche Diagnostics, stated, “Recognizing molecular markers like MET is crucial in selecting the right treatment, and this assay empowers clinicians to provide personalized options at critical points in the patient journey.”

Despite recent advances, lung cancer remains the world’s leading cause of cancer-related deaths, often caused by limited treatment options. NSCLC accounts for about 85 percent of all lung cancer cases, and among those with wild-type EGFR, around 25 percent show high MET protein expression, making MET a key biomarker for therapeutic decisions.

The FDA’s enhanced approval is supported by promising data from AbbVie’s Phase 2 LUMINOSITY study, which showed a 35 percent overall response rate and a median duration of response of 7.2 months in MET-high NSQ-NSCLC patients treated with Emrelis.

This marks the first immunohistochemistry (IHC) test approved for detecting MET expression. The assay evaluates the percentage and staining intensity of tumor cells, allowing pathologists to determine MET overexpression, which is defined as less than 50 percent of cells showing strong (3+) staining.

The new test highlights Roche’s leadership in accuracy diagnostics and expands its portfolio of IHC and in-situ hybridization (ISH) companion diagnostics, supporting informed clinical decisions and advancing tailored medicine.

Founded in 1896, Roche remains a developer in diagnostics and biotechnology, committed to refining lives through scientific innovation and patient-centric healthcare solutions.