Roche has announced that the FDA has approved the VENTANA MET (SP44) RxDx Assay, a companion diagnostic that detects the MET protein in non-squamous non-small cell lung cancer (NSQ-NSCLC) patients. The MET protein is over-expressed in some NSQ-NSCLC patients and serves as a predictive biomarker for response to c-Met-targeted therapy. The assay is the first companion diagnostic approved to aid in determining MET protein expression in NSQ-NSCLC patients, who may now be eligible for treatment with AbbVie's c-Met-targeted therapy Emrelis. Understanding the molecular drivers in NSCLC patients is critical for therapy selection, and identifying MET protein expression can provide timely, tailored treatment options that may improve patient outcomes. Lung cancer remains the leading cause of cancer-related deaths worldwide, with approximately 85% of lung cancers classified as NSCLC. Among advanced NSCLC patients with a normal epidermal growth factor receptor (EGFR) gene, around a quarter exhibit high levels of MET protein, making MET protein expression an important factor in determining treatment options. The FDA's approval is supported by data from the Phase 2 LUMINOSITY study, which showed patients with c-Met protein high expression who received Emrelis demonstrated a 35% overall response rate and duration of response with a median of 7.2 months. The launch of the first immunohistochemistry MET companion test represents an important addition to Roche's market-leading portfolio of immunohistochemistry and in situ hybridisation companion diagnostics. The VENTANA MET (SP44) RxDx Assay detects the MET protein and is scored by pathologists based on the percentage of tumour cells stained and the intensity of the staining.