Clinical Development & CDx

Your Essential Partner for Companion Diagnostic (CDx) Approvals

We provide a global solution to help make your next breakthrough a standard of care.

  • Our FoundationOne®CDx and FoundationOne®Liquid CDx tests have 60% of all CDx approvals for NGS testing in the United States and Japan – the most of any diagnostic company1
  • We have profiled over 500,000 patient samples in clinical trials and continue to expand our global reach by preparing our portfolio for the upcoming European Union In Vitro Diagnostics Regulation (EU IVDR) and offering clinical trial services in China through a local provider
  • We can help to strengthen your submissions with the Flatiron Health Foundation Medicine Clinico-Genomic Database (CGDB), which is a unique, regulatory-ready data resource.

Our track record of success includes CDx approvals in multiple countries, in specific or pan-tumor cancer indications, and across challenging variant types like fusions or multi-gene signatures.


We can accelerate global trials in any phase of development with our blood- and tissue-based testing and our trial services – now including PD-L1 testing and our Trial Boost™ service, which uses clinical patient results from local testing without requiring a new specimen to give your prospective trials a fast-pass.


The Flatiron Health Foundation Medicine CGDB contains data from more than 100,000 patients, and it can support custom use cases to fit your clinical development program, like natural history of disease studies or control arms using real-world data (RWD).

We Have Even More to Offer

Learn more about our comprehensive genomic profiling tests or explore our solutions for clinical development and companion diagnostics (CDx) or access and commercialization.

1. Data on file, Foundation Medicine, Inc., data as of Nov. 18, 2022.

Important Safety Information


FoundationOne CDx

FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies 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. Some patients may require a biopsy. For the complete label, including companion diagnostic indications and important risk information, please visit