Boston, Massachusetts, USA, May 21, 2026
Foundation Medicine has announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®CDx as a companion diagnostic for TEPMETKO® (tepotinib) to identify patients with MET exon 14 skipping alterations (METex14) in metastatic non-small cell lung cancer (NSCLC). The approval marks a significant advancement in precision oncology diagnostics and further strengthens Foundation Medicine’s leadership position in comprehensive genomic profiling for lung cancer treatment selection.
The latest FDA approval allows both FoundationOne®CDx tissue-based testing and FoundationOne®Liquid CDx blood-based testing to identify patients who may benefit from treatment with TEPMETKO®, a targeted therapy developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the United States and Canada. TEPMETKO previously received accelerated FDA approval in 2021 and full approval in 2024 for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations.
FDA Approval Advances Precision Oncology in NSCLC
MET exon 14 skipping alterations are found in approximately 3% to 4% of non-small cell lung cancer cases and are frequently associated with advanced disease progression and poor patient prognosis. Experts believe the latest approval may improve access to targeted therapies by expanding the availability of advanced genomic testing options capable of rapidly identifying eligible patients.
Foundation Medicine stated that the approval represents the company’s first companion diagnostic authorization powered by real-world data, highlighting a growing shift toward integrating clinical trial evidence with large-scale patient data analysis. The approval leveraged insights from more than 150,000 patients within the Flatiron Health–Foundation Medicine Clinico-Genomic Database (CGDB), allowing the company to support regulatory submissions through highly curated real-world evidence while reducing the need for additional large-scale patient enrollment studies.
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Company executives emphasized that the milestone demonstrates the increasing value of regulatory-grade real-world evidence in expanding diagnostic and therapeutic access for cancer patients. Foundation Medicine stated that integrating real-world data into companion diagnostic development could help accelerate precision medicine innovation while maintaining high scientific and regulatory standards.
The company also noted that tissue and blood-based genomic profiling options provide healthcare providers with greater flexibility in identifying actionable mutations, particularly in cases where tissue availability is limited or obtaining additional biopsies may be challenging.
Companion Diagnostics Drive Personalized Cancer Treatment
Foundation Medicine remains one of the global leaders in comprehensive genomic profiling and companion diagnostics for oncology applications. With the latest FDA authorization, the company now has more than 20 FDA-approved companion diagnostic indications in NSCLC and over 100 approved companion diagnostic indications overall, the highest among comprehensive genomic profiling companies.
FoundationOne®CDx is a next-generation sequencing-based in vitro diagnostic platform capable of analyzing more than 300 cancer-related genes using tumor tissue samples. The technology identifies genomic alterations including substitutions, insertions, deletions, copy number alterations, gene rearrangements, microsatellite instability, and tumor mutational burden, helping physicians select targeted therapies based on individual tumor biology.
Meanwhile, FoundationOne®Liquid CDx uses circulating cell-free DNA obtained from blood samples, enabling less invasive genomic testing for patients with advanced cancers. The company stated that the dual availability of tissue and liquid biopsy testing strengthens the precision medicine ecosystem by expanding patient access to genomic profiling regardless of sample type or disease stage.
Patient advocacy organizations welcomed the approval, noting that rapid and accurate biomarker testing remains essential for connecting patients with targeted therapies capable of improving treatment outcomes. Oncology specialists also highlighted that innovations combining genomic diagnostics, real-world evidence, and AI-powered data analysis may continue transforming personalized cancer care over the coming years.
Industry experts believe the latest approval further reinforces the growing role of companion diagnostics in modern oncology while accelerating broader adoption of precision medicine across lung cancer treatment pathways worldwide.
Source: Foundation Medicine press release
