FDA approves FoundationOne CDx as TEPMETKO companion diagnostic in NSCLC
- FDA cleared FoundationOne CDx as a companion diagnostic for EMD Serono’s TEPMETKO (tepotinib) to identify MET exon 14 skipping alterations in metastatic non-small cell lung cancer.
- The label expansion adds a tissue-based option alongside the previously cleared FoundationOne Liquid CDx blood test, broadening testing pathways for TEPMETKO eligibility.
- The approval leverages real-world evidence from more than 150,000 patients in the Flatiron Health-Foundation Medicine clinico-genomic database, marking the company’s first real-world data-powered companion diagnostic clearance.
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