Comprehensive Genomic-Profiling Assay FoundationOne CDx Is Commercially Available

On March 30, Foundation Medicine announced that FoundationOne CDx, the first U.S. Food and Drug Administration (FDA)-approved comprehensive genomic-profiling 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.

“Now that FoundationOne CDx is widely available in the United States, oncologists can begin using this valuable test to help guide and simplify personalized treatment decisions for their patients,” said Vincent Miller, MD, 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.”

More About FoundationOne CDx

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, 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 comprehensive genomic-profiling 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 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 and tumor mutational burden—that can help inform the use of other targeted oncology therapies, including immunotherapies and relevant clinical trial information.

For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please click here.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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