FoundationOne CDx: A Broad Companion Diagnostic Test for Cancer Tumors

Vincent Miller, MD, chief medical officer of Foundation Medicine, Industry Innovation Awardee, discusses FoundationOne CDx, an FDA-approved diagnostic that is clinically validated for solid tumors.

Miller: Foundation One CDx is the latest iteration and improvement in our genomic profiling assays for patients with advanced cancer, and really, it’s one of the pinnacles of my career because we took this assay through the US Food and Drug Administration (FDA), we obtained FDA approval, and with that, also received a National Coverage Determination from the Centers for Medicare and Medicaid Services—and that’s incredibly important for patients.

Advanced cancer is many, many diseases and that’s part of the reason why we have this honor here tonight. Because many, many genomic alterations can be the Achilles’ heel of a patient’s cancer, and even the most astute physicians can’t predict when they’re seeing a patient in practice what the underpinning of that cancer is. One really needs to take this broad-based diagnostic approach with a really robust test to determine what’s driving that potentially lethal cancer.