Clinical Trial & CDx Development

Advance your clinical trial enrollment and CDx development by utilizing our clinical trial solutions to identify the right patients, reduce regulatory risk, and accelerate your enrollment

Identify Patients

Utilize our portfolio of clinical trial assays to identify the right patients for your clinical trial

Reduce Regulatory Risk

Leverage our regulatory experience to support global clinical trials and reduce risks to approval

Accelerate Enrollment

Speed up your clinical trials by using our trial enrollment solutions to identify sites and patients of interest

Partner with Foundation Medicine to leverage our CDx development and clinical trial expertise for your therapy program

Our established NGS testing portfolio with existing approvals and new clinical trial assays can identify the right patients to enroll in your clinical trials


Identify common to complex biomarkers with our CDx approved tests

  • Foundation Medicine has nearly 60% of all approved CDx indications for NGS testing across the United States and Japan – the most of any diagnostic company1
  • Approved CDx indications across tumor types and pan-tumor indications
  • Ability to detect challenging variant types like fusions or multi-gene signatures

New clinical trial and CDx capabilities

  • We have experience to support clinical trials and submissions with new broad NGS platforms
  • New LDT capabilities for rare fusions, FoundationOne®RNA, and heme malignancies, FoundationOne®Heme

Enhance your submission with RWE

  • Our Clinico-Genomic Database (CGDB) powered CDx provides supplemental real-world evidence to support CDx submissions
Advance your global clinical trials with an experienced diagnostics partner

Foundation Medicine can support multiple paths to CDx with health authorities around the globe and can reduce risks to approval


United States

  • Only Foundation Medicine offers an FDA-approved portfolio with tissue and blood-based comprehensive genomic profiling tests2
  • Supported over 850 clinical trials2 with a track record of success

European Union

  • Completed IVDR submission for liquid biopsy and tissue NGS platforms
  • Successful experience with notification or authorization for clinical performance studies in 20+ EU member states


  • Dedicated Chugai team in Japan supporting two MHLW-approved tests with 35+ CDx indications


  • New partnership with Sequanta to support clinical trials in China and global regulatory filings
Our data trial solutions can help speed up your clinical trial enrollment

Leverage our timely data solutions and our extensive testing network to help you run faster, more efficient trials and accelerate your path to approval.

Download our Clinical Trial Solutions Overview

  • Identify specific sites with patients matching your trial criteria
  • Strategically prioritize sites for early trial planning and site identification
  • Weekly alerts help you find eligible patients to recruit
  • Enable timely education  for providers about clinical trials for their patients.
Trial BoostTM
  • Re-analysis of Foundation Medicine clinical results in less than 5 days for speedy trial enrollment and reduced patient burden

We can help you with your therapy development from initial discovery through regulatory approval and commercialization

Learn more about how we can help you with:

Biomarker Discovery & Translational Research

Biomarker Testing Access & Commercialization

Need More Details? 

We are here to help. Contact our Biopharma Team for more information. 

Contact Us

1. Data on File, Foundation Medicine, Inc., data as of May 4, 2023.

2. Data on File, Foundation Medicine, Inc., 2023.

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