FDA Approves Pan-Tumor Companion Diagnostic


The US Food and Drug Administration (FDA) has approved a next-generation sequencing assay that may be used as a companion diagnostic for therapy selection for solid tumors.

FoundationOne CDx is Foundation Medicine’s comprehensive companion diagnostic assay which aids physicians in clinical decision support. The assay provides a report that details the genomic profile of a patient’s tumor along with the associated approved therapies and relevant clinical trial data for such tumors. With this FDA approval, FoundationOne CDx may be utilized as a companion diagnostic for therapy selection for patients diagnosed with solid tumors.

“The approval of FoundationOne CDx represents a major advance in the personalization of cancer care, facilitating access for patients in the US to a comprehensive pan-tumor companion diagnostic that will help identify approved treatment options based on the molecular footprint of each individual’s cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development, in a statement (December 4, 2017). “Our belief is that profiling will increasingly become routine in clinical practice, so we have worked closely with Foundation Medicine to develop an extensive clinically and analytically validated platform that can support both existing and future companion diagnostic needs.”

The assay is capable of assessing all four classes of genomic alterations in 324 genes known to drive cancer growth, identifying patients with advanced cancer who are likely to respond to targeted therapies, and reporting genomic signatures and alterations for use by physicians for patient management.


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Additionally, the approval of FoundationOne CDx represents the first next-generation sequencing (NGS)-based companion diagnostic for alectinib (Alecensa), which is approved as a monotherapy for the treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer.—Zachary Bessette