Foundation Medicine Announces Commercial Availability of FoundationOne CDx, the First FDA-Approved Comprehensive Genomic Profiling Assay for All Solid Tumors Incorporating Multiple Companion Diagnostics.
Foundation Medicine, Inc. announced on March 30th, 2018 that FoundationOne CDx(TM), the first U.S. Food and Drug Administration (FDA) approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. FoundationOne CDx is a first-of-its-kind test for individuals with advanced cancer that is offered as a nationally covered benefit across all solid tumors for Medicare and Medicare Advantage beneficiaries who meet eligibility requirements. MyOncoPath’s genetic counselors can assist you with determining if FoundationOne CDx is right for you or your patients.
“Now that FoundationOne CDx is widely available in the U.S., oncologists can begin using this valuable test to help guide and simplify personalized treatment decisions for their patients,” Vincent Miller, M.D., chief medical officer at Foundation Medicine. “By integrating FoundationOne CDx early into routine clinical care, oncologists can create treatment efficiencies and expand access to biomarker-driven medicines for patients, with the potential to improve treatment outcomes.”
Expanded access to clinically and analytically validated genomic profiling may establish a path toward improved patient outcomes. Personalized, biomarker-based therapy has been shown to be associated with clinical benefit across tumor types and biomarkers,(1) making therapy selection ever more complex. FoundationOne CDx offers treating physicians a single, FDA-approved comprehensive platform for all solid tumors to detect specific genomic alterations that help guide efficient, personalized treatment decisions, while reducing the time and tissue needed when testing for biomarkers one at a time.
FoundationOne CDx, an FDA-approved CGP assay for all solid tumors, assesses genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment options. FoundationOne CDx is also FDA-approved as a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, 12 of which are approved as first line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), that can help inform the use of other targeted oncology therapies, including immunotherapies and relevant clinical trial information. In all of these ways, FoundationOne CDx is available to biopharma companies as an FDA-approved platform for clinical research and as a CGP platform for biopharma companies seeking to develop companion diagnostics for their precision therapeutics.
About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic.
For more information on FoundtionOne CDx and personalized cancer genetic testing please contact us. Fill out the form below to find out more about how we help cancer patients and their health care providers identify genetic testing that could play a role in personalizing cancer treatment plans: