Roche announced today that the U.S. Food and Drug Administration (FDA) has approved the VENTANA MET (SP44) RxDx Assay. This marks the first companion diagnostic approved to help identify patients with non-small cell lung cancer (NSCLC) who may be eligible for treatment with AbbVie's c-Met-targeted therapy, EMRELIS™.
The VENTANA MET (SP44) RxDx Assay detects the MET (also known as c-Met) protein, which is over-expressed in some NSCLC patients. This protein serves as a predictive biomarker for a patient's potential response to c-Met-targeted therapies.
About the VENTANA MET (SP44) RxDx Assay
The assay scores MET protein expression by analyzing tumor cell staining intensity. FDA approval was based on data from AbbVie's Phase 2 LUMINOSITY clinical study. By providing critical information on MET protein expression, the assay enables clinicians to determine the likelihood a patient will benefit from c-Met-targeted therapy, supporting a more personalized approach to treating NSCLC.
About Roche
Founded in 1896, Roche is a global leader in pharmaceuticals and diagnostics, dedicated to advancing scientific excellence to discover and develop innovative medicines and diagnostics. The company is a pioneer in personalized healthcare, aiming to improve and save lives worldwide.
For more information, visit www.roche.com.
