FDA Approves NGS Test for Any Solid Tumor Type


The US Food and Drug Administration (FDA) has granted approval to the first breakthrough-designated, next generation sequencing (NGS)-based test that detects mutations in 324 genes in any solid tumor type.

FoundationOne CDx (F1CDx) is a more extensive test than other companion diagnostics that matches one test to one drug approved by the FDA. Based on individual test results, F1CDx can identify which patients with any of five tumor types may benefit from 15 specific FDA-approved targeted treatment options.

“The F1CDx can help cancer patients and their health care professionals make more informed care decisions without the often-invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health (CDRH), in a press release (November 30, 2017). “With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options.”


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The Centers for Medicare & Medicaid Services (CMS) also proposed coverage of the F1CDx. The new diagnostic test is the second in vitro diagnostic to be approved and covered after overlapping review by the FDA and CMS under the Parallel Review Program.—Zachary Bessette