Foundation Medicine Achieves Historic Milestone of 100 Approved and Active Companion Diagnostic Indications, Solidifying Leadership in Precision Medicine

First and only company with 100 approved and active companion diagnostic indications for next-generation sequencing in the United States and Japan, setting the standard for high-quality genomic testing that helps accurately match patients to therapies

BOSTON - December 4, 2025 - Foundation Medicine, Inc., a precision medicine company transforming lives in cancer and beyond, today announced it has achieved a historic, unprecedented milestone of 100 approved companion diagnostic indications in the United States and Japan across FoundationOne®CDx and FoundationOne®Liquid CDx. Following its recent Ministry of Health, Labour and Welfare (MHLW) approval of FoundationOne CDx for a targeted therapy in NTRK fusion-positive solid tumors, Foundation Medicine is the first and only company with 100 approved companion diagnostic indications for next-generation sequencing, with 57 approvals in the United States¹ and 43 approvals in Japan.²

A companion diagnostic is a high-quality test relied on by healthcare providers to accurately match patients to therapies. These tests are the gold standard in personalized cancer care - they undergo extensive testing and review by an independent regulatory agency. Companion diagnostics are well proven to identify patients most likely to benefit from approved therapies, supplying healthcare providers with the information they need to direct personalized cancer care.

"Foundation Medicine paved the way for high-quality, accessible genomic testing by being the first to undergo parallel review by the Food and Drug Administration (FDA) and Centers for Medicare and Medicare (CMS), resulting in FDA approval of FoundationOne CDx as a pan-tumor companion diagnostic and a landmark national Medicare coverage determination," said Dan Malarek, chief executive officer at Foundation Medicine. "Since then, Foundation Medicine has continued to help usher in a new wave of precision medicine in cancer care. With 100 approved companion diagnostic indications, healthcare providers can confidently trust our high-quality and clinically actionable comprehensive genomic profiling tests. We are focused on making a meaningful difference in the lives of patients with cancer, allowing them to be matched to the most effective treatment based on the unique make-up of their cancer's DNA."

Foundation Medicine is the global leader in companion diagnostic approvals with more approved companion diagnostic indications for next-generation sequencing in the United States and Japan than any other company.³ The historic 100 companion diagnostic milestone translates directly to patient impact and reinforces the confidence biopharmaceutical partners need to accelerate innovation with Foundation Medicine's proven track record. Foundation Medicine has worked with biopharmaceutical companies to help bring over 35 medicines to more patients through our approved companion diagnostic indications and has delivered over 1.5 million patient comprehensive genomic profiling reports.⁴

Foundation Medicine's portfolio of tests offers healthcare providers both tissue- and blood-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Using a tissue sample, the FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient's tumor. From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights.

About Foundation Medicine
At Foundation Medicine, our mission is to transform lives in cancer and beyond. We strive to provide multi-modal precision diagnostic solutions to transform cancer care throughout a patient's experience, from pre-diagnosis to ongoing management and monitoring. Leveraging our vast knowledge of precision medicine, we partner with biopharmaceutical companies to accelerate the development of new personalized therapies in cancer and in a range of other diseases. For more information, visit us at www.FoundationMedicine.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

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 CDx
FoundationOne®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 www.F1LCDxLabel.com.

Media Contact:Abigail Linehan, [email protected]

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

¹ U.S. Food and Drug Administration. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Updated March 5, 2025. Accessed November 24, 2025. https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
² Pharmaceuticals and Medical Devices Agency. List of approved CDx in Japan. Updated November 20, 2025. Accessed November 24, 2025. https://www.pmda.go.jp/english/rs-sb-std/rs/0027.html
³ Data on File, Foundation Medicine, Inc., 2024
⁴ Data on file. Foundation Medicine, Inc., 2025