The FDA approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic for EMD Serono’s Tepmetko (tepotinib), expanding eligible sample types to include both tissue and liquid biopsy testing. The approval updates the biomarker workflow for MET exon 14 skipping alterations, shifting Tepmetko testing from a narrower assay footprint to broader patient access. Foundation said the new label transfers the existing seven companion diagnostic indications from the prior FoundationOne Liquid CDx approval, using real-world data from its Flatiron Health–Foundation Medicine clinico-genomic database. The company also highlighted that MET exon 14 skipping occurs in an estimated 3% to 4% of NSCLC tumors. Regulators have increasingly emphasized multi-modality testing approaches as sample availability and turnaround time remain recurring constraints in clinical practice.