About Our Products and Services
Our Proven Portfolio
Discover the only FDA-approved portfolio of comprehensive genomic profiling tests for all solid tumors. With FDA approvals for tissue- and blood-based tests, our portfolio can help guide treatment strategies for advanced cancer patients.
Our comprehensive approach to next-generation sequencing and rigorous commitment to quality has set the industry standard. By partnering with biopharma and clinical stakeholders alike, we’ve developed an extensive genomic database and body of research that have strengthened the services we can offer all of our customers.
Health Care Providers
Our industry-leading testing and services bring in-depth genomic insights, experience, and a breadth of offerings into every practice to help predict patient benefit across multiple targeted therapies in multiple cancer indications.
We provide actionable insights into the oncogenomics of both rare and common cancers, fueling discovery through commercialization by using a robust database and deep experience with FDA approvals.
Foundation Facts & Figures
Foundation Medicine has the most experience with comprehensive genomic profiling in the industry.*
Latest CDx Test
FoundationOne®Liquid CDx is the broadest FDA-approved blood-based comprehensive genomic profiling test, providing guideline-recommended genomic results from a simple blood draw.
Latest CDx Indication
Our FoundationOne®CDx tissue-based test now includes a pan-tumor companion diagnostic claim for a new indication of Keytruda® (pembrolizumab), for the identification of TMB-H patients (≥ 10 mutations/megabase) with unresectable or metastatic solid tumors.1
*As defined by the number of cancer patients tested by Foundation Medicine in a clinical setting with comprehensive genomic profiling and the amount of evidence published by Foundation Medicine in a research setting about comprehensive genomic profiling
1FDA approves pembrolizumab for adults and children with TMB-H solid tumors.https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors. Accessed June 17, 2020.
Important Safety Information
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. Patients who are negative for 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.