The 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 decision expands Foundation’s prior Tepmetko CDx coverage beyond liquid biopsy to include tissue-based testing, giving clinicians additional sample-type options. Foundation said the approval uses its real-world data-powered CDx offering and leverages outcomes tied to its Flatiron Health-Foundation Medicine clinico-genomic database. The company also emphasized that this becomes the first companion diagnostic approval based on its “real-world data-powered” approach for label expansion support. Tepmetko received accelerated approval in 2021 for metastatic NSCLC with MET exon 14 skipping alterations and full approval in February 2024. Foundation estimates MET exon 14 skipping alterations occur in roughly 3–4% of NSCLC tumors and are associated with poor prognosis, making timely and accurate diagnostics important. For the diagnostic market, the update also reinforces the growing role of tissue-and-liquid label expansion strategies to reduce testing bottlenecks and accelerate treatment matching.