Genetic Test Evaluation

understanding how genetic tests impact patient management

FoundationOne CDx (Foundation Medicine Inc.)

August 29, 2018

According to the testing laboratory, the FoundationOne CDx (F1CDx) is a companion diagnostic test used to identify patients who may benefit from treatment with Food and Drug Administration (FDA)-approved targeted therapies. Additionally, the test is intended to provide tumor mutation profiling that includes the screening of biomarkers without companion diagnostic claims. This report evaluates the analytical validity, clinical validity, and clinical utility of the F1CDx test.