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Discovery & Translational Research

Endless Possibilities for Your Global Drug Development with One High-Quality Comprehensive Portfolio

Our proven portfolio of tests, data solutions, and services can accelerate your efforts in biomarker discovery and translational research.

  • Discover new ways to stratify patients or gain early insights into treatment response

  • Identify and validate biomarkers, from the common examples, like EGFR, to novel or complex signatures, like homologous recombination deficiency (HRD)

  • Characterize tumor biology or search for patterns of drug resistance to inform future trials and development

We have a portfolio of tests to help you gain early insights into treatment response and advance your translational research, using serial ctDNA analysis with our liquid biopsy testing (shown left) or personalized monitoring with FoundationOne®Tracker, our tissue-informed ctDNA monitoring test.1,2

Our portfolio of tests, with a leading tissue and liquid biopsy, sequence DNA or RNA to offer results on 300+ genes and complex biomarkers like tumor fraction (TF)3, tumor mutational burden (TMB), microsatellite instability (MSI), and homologous recombination deficiency (HRD) to ensure we can meet the needs of your clinical program.

Gene List for F1LCDx

With our portfolio, you can characterize the genomics of your clinical cohort or identify distinct classes of resistance and drug-specific patterns, like KRAS G12C (shown left)4, to help identify combination trial opportunities and inform your clinical development programs.

Search for novel targets or design your clinical trials using our unique dataset

  • The Flatiron Health Foundation Medicine Clinico-Genomic Database (CGDB) is a unique, regulatory-ready data resource through a partnership with Flatiron Health, a leading provider of clinical data

  • CGDB contains data from more than 100,000 patients, including our rich genomics data and Flatiron Health’s clinical data from electronic medical records, including detailed information on a patient diagnosis, treatment history, and outcomes

Support research activities such as:

  • Biomarker Discovery & Validation

  • Clinical Trial Design

  • Natural History of Disease Studies

  • Real-World Data (RWD) Control Arms

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 Shum E, et al. Abstract presented at AACR 2022. Abstract CT184.

2 FoundationOne®Tracker is currently available only for research use. It is not available for clinical use. It has not been reviewed or approved by the FDA.

3 Reichert et al. Annals of Oncology 2022. Prognostic value of plasma circulating tumor DNA fraction across four common cancer types: a real-world outcomes study https://doi.org/10.1016/j.annonc.2022.09.163

4 Awad MM, et al. N Engl J Med 2021; 384:2382-2393. Awad et al 2021 Acquired resistance to KRAS G12C inhibition (v1.0)

Important Safety Information

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FoundationOne CDx

FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for advanced 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

FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced 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.