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Foundation Medicine Receives FDA Approval for FoundationOne®Liquid CDx as a Companion Diagnostic for TEPMETKO® in NSCLC

NextEdge Admin

19 Nov 2024

2 min 14 sec

FDA approval,companion diagnostic,lung cancer

Foundation Medicine, Inc. has announced FDA approval for its FoundationOne®Liquid CDx as a companion diagnostic for TEPMETKO® (tepotinib), developed by EMD Serono, the healthcare business of Merck KGaA in Darmstadt, Germany. TEPMETKO received FDA accelerated approval in 2021 and traditional approval in February 2024 for treating adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations (METex14). FoundationOne Liquid CDx is the first FDA-approved liquid biopsy to identify patients eligible for TEPMETKO.

NSCLC accounts for approximately 85% of lung cancers, with 3–4% associated with METex14 alterations, which are linked to advanced disease and poor prognosis. FoundationOne Liquid CDx analyzes over 300 cancer-related genes from a routine blood sample, enabling comprehensive genomic profiling.

“This approval highlights the critical role of high-quality liquid biopsies in expanding precision medicine access,” said Mia Levy, M.D., Ph.D., Chief Medical Officer at Foundation Medicine. “Our test empowers clinicians to identify more patients with METex14 alterations for targeted treatment.”

Foundation Medicine leads in FDA-approved companion diagnostic indications, offering the most robust portfolio for NSCLC. The company has 19 FDA-approved indications for NSCLC and 50% of all NGS-based approvals in the U.S. and Japan.

Laurie Ambrose, CEO of GO2 for Lung Cancer, emphasized the significance of biomarker testing in making advanced treatments accessible, praising the role of non-invasive liquid biopsies in enhancing patient care.