Foundation Medicine’s FoundationOne Cancer Tracker Named Breakthrough Device

Foundation Medicine’s circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOne Tracker, has been granted the FDA’s Breakthrough Device designation.

The assay uses algorithms to identify patient-specific variants that allows for the detection of ctDNA in plasma. The Breakthrough Device designation covers the assay’s use in the detection of residual disease in early-stage cancer after curative therapy.

The FoundationOne Tracker can help guide therapy decisions depending on disease status and an individual’s risk of relapse.

Foundation Medicine codeveloped the tracker with Natera, a clinical genetic testing company based in Austin, Tex.