Swiss healthcare company Roche has received the US Food and Drug Administration (FDA) approval for its VENTANA MET (SP44) RxDx Assay.
The assay detects the MET protein, also known as c-Met, a biomarker overexpressed in certain NSQ-NSCLC patients.
Its expression indicates the effectiveness of c-Met-targeted treatments, such as AbbVie’s Emrelis (telisotuzumab vedotin-tllv).
VENTANA MET is the first companion diagnostic test intended to identify non-squamous non-small cell lung cancer (NSQ-NSCLC) patients eligible for treatment with Emrelis.
Roche Diagnostics CEO Matt Sause said: “Understanding the molecular drivers in patients with non-small cell lung cancer is critical for therapy selection.
“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 FDA’s accelerated approval of the VENTANA MET (SP44) RxDx Assay is supported by data from AbbVie’s Phase 2 LUMINOSITY study.
The ongoing study evaluates the efficacy and safety of Emrelis in c-Met overexpressing advanced NSQ-NSCLC populations.
In the Phase 2 study, the VENTANA MET test served as the enrollment assay and showed a 35% overall response rate and a median duration of response of 7.2 months.
The VENTANA MET (SP44) RxDx Assay is scored by pathologists based on the percentage and intensity of tumour cell staining.
MET protein overexpression is defined as strong staining in 50% or more of tumour cells.
The assay helps clinicians in determining the likelihood of a patient’s benefit from c-Met-targeted therapy, fostering a more personalised approach to treating NSQ-NSCLC.
Recently, Roche has introduced the Elecsys PRO-C3 test, designed to assess liver fibrosis in people with metabolic dysfunction–associated steatotic liver disease (MASLD).
The diagnostic solution was developed through a licensing partnership with Nordic Bioscience and will be available on Roche’s cobas analyser systems.
