The FDA approved Foundation Medicine’s FoundationOne CDx tissue assay as a companion diagnostic for EMD Serono’s Tepmetko (tepotinib) to identify metastatic non-small cell lung cancer patients with MET exon 14 skipping alterations. The approval expands Foundation’s earlier companion diagnostic coverage to include both tissue-based and liquid biopsy formats. This marks another step in the Tepmetko diagnostic label expansion process after accelerated approval for the drug in 2021 and full approval in February 2024. MET exon 14 skipping alterations occur in an estimated 3–4% of NSCLC tumors, often linked to poor prognosis. For clinicians and testing labs, the key operational impact is broader test modality availability, which can reduce delays when sample quantity or tissue access is limited.