Roche's New Lung Cancer Diagnostic Test Ventana MET (SP44) RxDx Receives FDA Approval as Companion Diagnostic for AbbVie’s Emrelis

On May 14, Roche announced that its Ventana MET (SP44) RxDx Assay has been approved by the U.S. Food and Drug Administration as a companion diagnostic to identify which lung cancer patients are eligible for treatment with AbbVie's Emrelis (telisotuzumab vedotin-tllv).

This assay detects the MET protein, which is overexpressed in some patients with non-squamous non-small cell lung cancer and can serve as a biomarker to predict the likelihood of a patient's response to targeted therapies like Emrelis. In a statement, Roche noted that the immunohistochemistry assay is scored by pathologists based on the proportion of stained tumor cells and the intensity of staining.

The company pointed out that approximately 85% of lung cancers are classified as NSCLC, and among patients with advanced NSCLC who have the wild-type EGFR gene, about 25% exhibit higher levels of MET protein. Therefore, MET expression is a key factor in selecting treatment methods for these patients.

The approval was based on data from AbbVie's Phase 2 LUMINOSITY clinical study, which used the test as an enrollment assay.

Roche Diagnostics CEO Matt Sause said in a statement: "Understanding the molecular drivers of non-small cell lung cancer patients is crucial for selecting treatment options. By identifying the expression of MET protein during the patient's treatment process, we can help provide timely, tailored treatment plans, thereby improving patient outcomes and bringing hope to those facing this challenging disease."