About Our Products and Services
Our Proven Portfolio
Discover our portfolio of comprehensive genomic profiling tests. With 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.*
FoundationOne Liquid is our next-generation liquid biopsy test for solid tumors utilizing circulating tumor DNA (ctDNA). FoundationOne Liquid may help inform cancer care 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.
FoundationOne CDx is the only FDA-approved in vitro diagnostic test by Foundation Medicine. FoundationOne Liquid and FoundationOne Heme were developed and their performance characteristics determined by Foundation Medicine. They have not been cleared or approved by the U.S. Food and Drug Administration. For more information on our laboratory developed tests (LDTs) please see their respective Technical Specifications at www.foundationmedicine.com.
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.