Posted by Michael Wonder on 16 Feb 2022
Foundation Medicine’s ctDNA monitoring assay, FoundationOne Tracker, granted breakthrough device designation by U.S. Food and Drug Administration
15 February 2022 - Foundation Medicine today announced that the U.S. FDA has granted a breakthrough device designation for its circulating tumour DNA (ctDNA) detection and molecular monitoring assay, FoundationOne Tracker.
The assay uses optimised algorithms for identifying patient specific variants and a personalised assay design that allows for the detection of ctDNA in plasma.
