Workflow
Roche receives FDA approval for the VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-squamous non-small cell lung cancer patients eligible for treatment with Emrelis
RocheRoche(US:RHHBY) GlobeNewswire News Room·2025-05-14 20:00

Core Insights - Roche announced the FDA approval of the VENTANA® MET (SP44) RxDx Assay, the first companion diagnostic for determining MET protein expression in non-squamous non-small cell lung cancer (NSQ-NSCLC) patients, enabling eligibility for AbbVie's c-Met-targeted therapy Emrelis™ [1][2][3] Company Overview - Roche, founded in 1896 in Basel, Switzerland, is the world's largest biotechnology company and a leader in in-vitro diagnostics, focusing on developing medicines and diagnostics to improve patient lives [4] - The company emphasizes personalized healthcare and collaborates with various stakeholders to enhance healthcare delivery [4] Industry Context - Lung cancer is the leading cause of cancer-related deaths globally, with approximately 85% classified as NSCLC, often diagnosed at advanced stages with limited treatment options [1][2] - Among advanced NSCLC patients with a normal EGFR gene, about 25% exhibit high levels of MET protein, making it a critical factor in treatment decisions [1][2][3] Product Details - The VENTANA MET (SP44) RxDx Assay detects MET protein and is scored based on tumor cell staining percentage and intensity, informing clinicians about the likelihood of patient response to c-Met-targeted therapy [3][6] - The FDA's approval is based on data from AbbVie's Phase 2 LUMINOSITY study, which showed a 35% overall response rate and a median duration of response of 7.2 months for patients with high c-Met protein expression receiving Emrelis [2][3]