U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for TEPMETKO® (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in[...]

Foundation Medicine's tissue and liquid biopsy tests can now be used to identify more patients eligible for treatment who could benefit from TEPMETKO®

This is Foundation Medicine's first real-world data-powered approval for a companion diagnostic

BOSTON, May 21, 2026 - Foundation Medicine, Inc., a global, patient-focused precision medicine company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic (CDx) for TEPMETKO® (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. TEPMETKO received accelerated approval from the FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations (METex14).¹

METex14 is found in 3-4% of NSCLC cases² and is commonly associated with advanced disease and a poor prognosis.³ In November 2024, through Foundation Medicine's longstanding partnership with Merck KGaA, Darmstadt, Germany, Foundation Medicine's high-quality blood-based comprehensive genomic profiling test, FoundationOne®Liquid CDx, became the first FDA-approved companion diagnostic to identify patients who may be eligible for TEPMETKO.

FoundationOne CDx as a companion diagnostic for this therapy marks the company's first approval leveraging its real-world data-powered CDx offering, a service that supports drug and diagnostic label expansion by supplementing clinical trials with expertly curated real-world evidence and integrated regulatory support. Drawing on data from over 150,000 patients in the Flatiron Health-Foundation Medicine Clinico-genomic Database (CGDB), Foundation Medicine is well-positioned to generate relevant and harmonized real-world data (RWD) cohorts reducing the need for incremental patient enrollment while maintaining the rigor required for regulatory use in companion diagnostic projects.

Foundation Medicine is the global leader in companion diagnostic indications.⁴ With today's approval, it has more than 20 FDA-approved companion diagnostic indications for NSCLC, and over 100 approved companion diagnostic indications in total, the most of any comprehensive genomic profiling company.⁵

"This approval reinforces the importance of having diverse, high-quality testing options to support healthcare providers in making informed treatment decisions for their patients, regardless of available sample type," said Todd Druley, M.D., Ph.D., Chief Medical Officer at Foundation Medicine. "This milestone also highlights our commitment to finding novel avenues to enable expanded patient access. In the many cases where samples are depleted and the time needed for a new trial is unfeasible, rigorous, regulatory-aligned real-world evidence can complement pre-existing clinical trial data to help expand the available options for patients."

"Innovation in targeted therapies for lung cancer has helped pave the way for progress in precision medicine, but there is still so much work needed to connect the right patients to the right therapies, and to find new options for patients," said Danielle Hicks, Co-Interim Chief Executive Officer and Chief Patient Officer at GO2 for Lung Cancer. "We're excited to see the value that regulatory-grade, real-world data can add to increase agility, while maintaining the highest standards for patient care."

Foundation Medicine is the only company to offer both tissue and blood-based comprehensive genomic profiling tests that are approved by the FDA. Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes in a patient's tumor.

Foundation Medicine and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

About Foundation Medicine
Foundation Medicine is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases. We provide tests and solutions to transform care throughout a patient's experience, from defining a diagnosis to determining the appropriate treatment to ongoing monitoring. We help accelerate the development of new personalized therapies by leveraging our vast knowledge of precision medicine, real world data and AI-powered tools, expanding the information our diagnostic solutions provide to enable improved outcomes for patients. Every day, we are inspired to think differently to transform the lives of people living with cancer and other diseases. For more information, visit us at www.FoundationMedicine.com and follow us on LinkedIn, X, YouTube, Facebook, Instagram and BlueSky.

About FoundationOne®CDx FoundationOne®CDx is a next-generation sequencing-based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit https://www.F1CDxLabel.com.

About FoundationOne®Liquid CDxFoundationOne®Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit https://www.F1LCDxLabel.com.

Media Contact:Holly Campbell, [email protected]

¹ TEPMETKO. Prescribing Information. EMD Serono; 2024. Accessed May 7, 2026. https://www.emdserono.com/us-en/pi/tepmetko-pi.pdf
TEPMETKO® is a registered trademark of Merck KGaA, Darmstadt, Germany.
² The Cancer Genome Atlas Research Network. Comprehensive molecular profiling of lung adenocarcinoma. Nature. 2014;511:543-550. https://doi.org/10.1038/nature13385
³ Awad MM, Leonardi GC, Kravets S, et al. Impact of MET inhibitors on survival among patients with non-small cell lung cancer harboring MET exon 14 mutations: a retrospective analysis. Lung Cancer. 2019;133:96-102. https://doi.org/10.1016/j.lungcan.2019.05.011
⁴ Data on File, Foundation Medicine, Inc. 2025
⁵ List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Accessed May 7, 2026. https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.