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.
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.
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).
1. Data on file, Foundation Medicine, Inc., data as of Nov. 18, 2022.
Important Safety Information
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®Tracker is a clinical test performed exclusively as a laboratory service. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). FoundationOne Tracker is a personalized assay for oncology that is based on patient-specific somatic variants (substitutions and short insertions/deletions) identified from baseline tumor tissue testing and used to detect and longitudinally measure plasma circulating tumor DNA (ctDNA) abundance as a biomarker for tumor burden. Treatment decisions are the responsibility of the treating physician. ctDNA detection sensitivity may be limited if blood collection occurs within two weeks of surgery or while a patient is on therapy. A negative test result does not definitively indicate the absence of cancer. This test is not designed to detect or report germline variation, nor does it infer hereditary cancer risk for a patient. This test is designed to detect ctDNA from the assayed tumor only; new primary tumors will not be detected. This test is expected to have limited sensitivity in some cancer types due to limited ctDNA shed.
FoundationOne Liquid CDX
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.