Ventana MET RxDx Assay Receives FDA Approval as Companion Diagnostic in NSCLC

The FDA approved the Ventana MET RxDx assay to guide Emrelis use in patients with non-squamous non–small cell lung cancer and high MET protein expression.

The Ventana MET (SP44) RxDx assay has received approval from the United States Food and Drug Administration (FDA), making it the first companion diagnostic to aid in determining MET (also known as c-Met) protein expression for patients with non-squamous non–small cell lung cancer according to a news release from Roche Diagnostics.

The news release notes that these patients may now qualify for treatment with the c-Met-targeted therapy, Emrelis (telisotuzumab vedotin-tllv). Notably, the regulatory agency recently approved treatment with Emrelis on May 14^th, 2025.

“Understanding the molecular drivers in patients with non–small cell lung cancer is critical for therapy selection,” said Matt Sause, CEO of Roche Diagnostics, in the news release. “By identifying MET protein expression at the appropriate stage in the patient journey, we can help provide timely, tailored treatment options that may improve patient outcomes and offer hope to those facing this challenging disease.”

The Ventana MET RxDx assay is utilized in the detection of MET protein, which is often over-expressed in patients with non-squamous non-small cell lung cancer. The percentage of tumor cells stained is then reviewed and scored by pathologists based on the intensity of the staining, thus informing clinicians on the likelihood that a patient will benefit from c-Met-targeted therapy. Given the critical information on MET protein expression, this allows for a more personalized approach to treating this patient population.

This FDA approval is supported by data from the phase 2 LUMINOSITY study, in which, the test was utilized as an enrollment assay. Moreover, this clinical trial also supported the May regulatory approved of Emrelis treatment. The clinical trial criteria describe MET protein overexpression as when 50% or more tumor cells demonstrate strong (3+) membrane and/or cytoplasmic staining.

More Information on the Now-Approved Companion Diagnostic

Despite advances in the treatment landscape, lung cancer remains the leading cause of cancer-related mortality among both men and women globally. Lung cancer is frequently diagnosed at an advanced stage, when therapeutic options are limited; the median survival is less than one year. Approximately 85% of lung cancers are classified as non–small cell lung cancer, the news release notes.

Among patients with advanced non–small cell lung cancer and a normal (wild-type) epidermal growth factor receptor (EGFR) gene, approximately 25% exhibit elevated MET protein expression, making MET an important factor for guiding treatment decisions in this population.

The LUMINOSITY trial is an ongoing study evaluating the efficacy and safety of Emrelis in patients with c-Met–overexpressing advanced non-squamous non–small cell lung cancer. Results from the trial showed that of the 84 patients with high c-Met protein expression who received Emrelis achieved an overall response rate of 35%, with a median duration of response of 7.2 months.

What is Emrelis?

The Emrelis accelerated FDA approval marks the therapeutic agent as the first and only antibody drug conjugate approved for patients with previously treated, advanced non–small cell lung cancer with high c-Met protein overexpression.

The agent was found to be safe as well as effective in the phase 2 trial, according to a prior news release from AbbVie.

Peripheral neuropathy, fatigue, decreased appetite and peripheral edema were the most common side effects reported to have occurred in at least 20% of the patients treated. Decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium made up the grade 3 (severe) and 4 (life-threatening) laboratory abnormalities which occurred in at least 2% of patients.

In this prior news release, Dr. Jonathan Goldman, a professor of medicine in the Hematology/Oncology Division at UCLA Health, stated: “We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes. People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and Emrelis is a first-in-class antibody-drug conjugate that can address a critical unmet need for this patient population.”

Goldman is also the director of Clinical Trials in Thoracic Oncology and the associate director of Early Drug Development at UCLA Health, as well as the chair of University of California Lung Cancer Consortium.

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