Utilize our portfolio of clinical trial assays to identify the right patients for your clinical trial
Leverage our regulatory experience to support global clinical trials and reduce risks to approval
Speed up your clinical trials by using our trial enrollment solutions to identify sites and patients of interest
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
New clinical trial and CDx capabilities
Enhance your submission with RWE
Foundation Medicine can support multiple paths to CDx with health authorities around the globe and can reduce risks to approval
United States
European Union
Japan
China
Leverage our timely data solutions and our extensive testing network to help you run faster, more efficient trials and accelerate your path to approval.
Learn more about how we can help you with:
1. Data on File, Foundation Medicine, Inc., data as of May 4, 2023.
2. Data on File, Foundation Medicine, Inc., 2023.
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 www.F1CDxLabel.com
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as 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. When considering eligibility for certain therapies for which FoundationOne Liquid CDx is a companion diagnostic, testing of plasma is only appropriate where tumor tissue is not available. Patients who are negative for other 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.