The FDA approved an expanded companion diagnostic label for Foundation Medicine’s FoundationOne CDx to support EMD Serono’s Tepmetko (tepotinib) in metastatic NSCLC with MET exon 14 skipping alterations. The decision adds both tissue and liquid biopsy testing pathways, following an earlier approval for the FoundationOne Liquid CDx assay. Foundation said the Tepmetko label expansion is the first CDx approval based on its real-world-data powered approach, drawing on the Flatiron Health-Foundation Medicine clinico-genomic database. Tepmetko received accelerated approval in 2021 and full approval in February 2024 for the same molecular subset. MET exon 14 skipping alterations occur in an estimated 3% to 4% of NSCLC tumors and are associated with poor prognosis. The labeling update reinforces the current regulatory emphasis on providing multiple sampling options while maintaining test rigor and label-aligned evidence generation for oncology precision medicine.