FDA approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic for EMD Serono’s Tepmetko (tepotinib) to identify metastatic NSCLC patients with MET exon 14 skipping alterations. The approval expands Foundation’s earlier companion diagnostic coverage for Tepmetko to include both tissue-based and liquid biopsy assays. The update matters in metastatic settings where MET exon 14 skipping occurs in an estimated 3% to 4% of NSCLC tumors and is associated with poor prognosis. FDA previously granted accelerated approval for Tepmetko in 2021 and later expanded to full approval in February 2024. For providers, the expanded CDx pathway aims to give additional validated options when tissue is unavailable or when liquid biopsy is preferred for timely decision-making.