Foundation Medicine FoundationOne CDx

Foundation Medicine's FoundationOne CDx is now available in the US, following approval by the US Food and Drug Administration last year and finalization of a national coverage determination by the Centers for Medicare and Medicaid Services earlier this month. The test is available for patients with advanced solid tumor cancers. It assesses genomic alterations in 324 cancer genes and serves as a companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer, and breast cancer to determine if they could benefit from one of 17 on-labeled therapies, of which 12 are approved as first-line therapy for their respective indication. In addition, the test reports genomic biomarkers, such as microsatellite instability and tumor mutational burden that can help inform the use of immunotherapies.