Partnering with Providers
Foundation Medicine’s proven portfolio of tests and services offers the quality and commitment you need to help inform treatment strategies for your advanced cancer patients. Discover in-depth genomic insights and a breadth of offerings to help you integrate comprehensive genomic profiling into your practice.
Comprehensive Genomic Profiling Tests
Discover tissue- and blood-based FDA-approved comprehensive genomic profiling testing for all solid tumors with FoundationOne®CDx and FoundationOne®Liquid CDx. In addition, FoundationOne®Heme is a laboratory developed test for hematologic malignancies, sarcomas, or solid tumors where fusion detection is desired.
Online Ordering & Report Integrations
Foundation Medicine offers online ordering, digital reporting, and EMR and API integrations to help integrate comprehensive genomic profiling into your workflow.
Clinical Research & Trial Matching
Leverage our molecular information through our clinical research and trial matching services to help inform treatment decisions for your patients.
Decision Support & Provider Education
From interpretation of results on each report to expert consultations and ongoing education, we can help you make the most of comprehensive genomic profiling (CGP) in your practice.
Foundation Facts & Figures
Foundation Medicine has the most experience with comprehensive genomic profiling in the industry.*
Patient Samples Profiled
Actionable Insights Upfront
We understand that treatment planning for your cancer patients can be complex. That’s why we’re updating our FoundationOne CDx and FoundationOne Liquid CDx reports to pull the “Professional Services” summary section to the first page. This update will bring information for all reported biomarker and genomic findings and our new “Report Highlights” section upfront, to help you focus on the critical findings for your patients.
FoundationOne®CDx Adds First Group-Based CDx Claim
The U.S. Food and Drug Administration (FDA) has approved FoundationOne CDx as a companion diagnostic for a group of BRAF inhibitors and BRAF/MEK inhibitors in combination for melanoma patients with BRAF V600E and BRAF V600E/K mutations. FoundationOne CDx is the first comprehensive genomic profiling test to receive approval for a group-based companion diagnostic (CDx) claim.1 Based on this approval, FoundationOne CDx is now approved as a CDx for current and future therapies that are approved under these group indications.2
* 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. 1 U.S. Food & Drug Administration. List of Cleared or Approved Companion Diagnostic Devices. Content current as of December 9, 2021. Accessed December 9, 2021. www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools
2 FoundationOne CDx reports will include this indication by January 20th, 2022
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.